7,286 Director Of Quality jobs in the United States
Director, Quality Control
Posted today
Job Viewed
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within in Quality Control within the CMC function, this position will be responsible for overseeing a team and individually contributing to the management of QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP) and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC related activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
- Provide strategic and tactical ownership for QC activities of late phase and commercial programs, including but not limited to commercial launch readiness including establishment of CDMO and/or CTL.
- End to end process management for analytical purposes in support of manufacturing operations for release of commercial product.
- Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs) for release and stability purposes.
- Manage quality events related to commercial QC testing such as lab investigation (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0) and CAPAs.
- Support regulatory submissions and commercial life cycle management to maintain operational uniformity.
- Collaborate with cross functional teams including CMC RA, DS, DP, Supply Chain and Quality Assurance to achieve project goals per timelines.
- BS or MS in Chemistry, Pharmaceutical Science or related discipline.
- 10+ years of relevant industrial experience in analytical development/QC.
- Solid understanding of relevant compliance and regulatory requirements as applicable to data integrity, process validation, manufacture sampling and testing, stability study, method validation and transfer, etc.
- Effective written and verbal communication skills and interpersonal skills.
- Extensive knowledge and understanding of cGMP guidelines and practices, as well as related / best industry practices.
- Strong problem-solving skills with sound technically driven decision-making ability
- Excellent communication skills (verbal, written and technical), strong interpersonal/collaboration skills and planning skills.
- Ability to think critically and creatively and be able to work independently to determine appropriate resources for resolution of problems.
- Ability to multi-task and thrive in a fast-paced innovative environment.
- Experience in solid oral dosage including dissolution testing.
- Work experience and knowledge of global regulatory submissions (IND, IMPD, NDA and MAA, etc.) is preferred.
- Commercial QC experience.
- Chromatographic experience in development, optimization, and troubleshooting.
The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact
#LI-Hybrid #LI-CT1
Director - Quality Control
Posted 12 days ago
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Job Description
**Position Summary**
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Working for Catalent Biologics is an opportunity to join an entrepreneurial team. Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast-growing business, backed by a private company. People joining our team will have the opportunity for career development as our business continues to grow and expand. Catalent-Madison employees are helping to improve future patient outcomes by working on products that are designed to treat COVID-19, cancer, various autoimmune, fibrotic and blood disorders, HIV, diabetes, heart and lung diseases as well as Alzheimer's.
The Director of Quality Control is responsible for all activities within the QC department. The QC team is responsible for testing products, raw materials, and the manufacturing environment to ensure the safety, quality, identity, purity, and potency produced by the Catalent Madison Biologics facility. The QC team is comprised of the following groups: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation and Sample Management.
Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
**The Role**
+ Manage QC resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, procedures, protocols, and reports.'
+ Interact and communicate with customers to ensure expectations are established, agreed to, and achieved.
+ Engage actively with Project Management and other department functions to ensure that CGMP programs are properly supported in order to achieve expectations; maintain effective and professional communication between all parties, including the customer.
+ Develop a team of quality professionals to support quality systems and investigation management objectives and ensure continual quality improvement.
+ Accountable for all activities within the Quality Control department: Microbiology, Environmental Monitoring, Stability, Release and In-Process, Method Validation, Sample Management as well as other functions (which include: technical data review, training, instrument maintenance, lead investigator, LIMS).
+ Effectively communicates Quality vision and expectations across site, including periodic site wide GMP training in addition to focused trainings.
+ Drives systemic process changes as a result of Deviations/Complaints and other quality trends.
+ Helps define department objectives to align with BU goals. Regularly communicates to team, department and company about department and company priorities. Monitors and evaluates social, fiscal, and political trends that affect the plan.
+ Other duties as assigned.
**The Candidate**
+ Doctorate Degree in STEM discipline with 8+ years related experience, OR Master's Degree in STEM discipline with 12+ years related experience, OR Bachelor's Degree in STEM discipline with 15+ years related experience.
+ 6+ years of leadership experience required.
+ Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, GM Excellence, and GROW) may be considered in place of external experience.
+ Understand the requirements of clinical and commercial programs for active pharmaceutical ingredients and bulk drug substances.
+ Ability to communicate complex technical information to non-technical audiences.
+ Able to lead difficult discussions with customers and subordinates and drive the conversation to an acceptable resolution.
+ Able to combine and interpret data from multiple disciplines and has a commanding understanding of the full Biologics process.
+ Experienced in all aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones.
**Why You Should Join Catalent**
+ Defined career path and annual performance review and feedback process
+ Diverse, inclusive culture
+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
+ Dynamic, fast-paced work environment
+ Community engagement and green initiatives
+ Generous 401K match and Paid Time Off accrual
+ Medical, dental and vision benefits effective day one of employment
+ Tuition Reimbursement
**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers ( to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE ( .
Director, Quality Control
Posted today
Job Viewed
Job Description
Job Description
Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a clinical stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.
Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.
Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.
The Position
The purpose of this position within the Quality and Compliance department is to lead Quality Control (QC) Laboratory consisting of analytical, microbial, stability, reference standard quality control. This includes the establishment and optimization of processes, procedures, analytical methods, and ensuring our Quality Control (QC) align with business strategy and needs. Functions as the GMP laboratory testing technical consultant to QC staff, business operations per strategic business needs.
Responsibilities
- Setting strategy, planning, coordinating, directing, coaching, developing, hiring, and planning the resources, facilities and budgets to manage QC laboratory including setting of vision and strategy, develop and manage operating budgets, management of technical employees, project management, and unit operational management.
- Apply scientific and technological expertise to the validation and optimization of analytical techniques for the identification and characterization of molecules oligo- and polynucleotides and raw materials in cGMP compliant laboratories. Apply extensive advanced scientific knowledge to design and manage multi-disciplinary projects.
- Provide leadership in product testing and Quality System to support overall business operations. Responsible for site processes and procedures related to Quality Control laboratory to ensure product quality and compliance.
- Provide technical leadership in a multidisciplinary environment to ensure activities are on track per business needs and established timeline. Serves as an expert in technical/functional areas.
- Apply advanced technical writing skills to prepare project protocols and reports to support product registration and/or business needs. Technical Reports and Procedural Documents (SOPs, Wis, Test Methods, Policies, Forms, ).
- Develop, negotiate, finalize timelines and cost estimates for projects and/or service contracts to support business operations and/or external partner's needs.
- Represent QC function during 3rd party, QP, and regulatory inspections at Verona, WI facility.
- Hiring and development of QC department staff at the Verona, WI
- Other duties consistent with the position as assigned from time to time.
Requirements:
- Master's Degree
- 10 years of experience in a GxP pharmaceutical/biotech company, contract manufacturing organization, or contract research
- 5 years of experience Directing QC laboratory in cGMP facility.
- Extensive knowledge of GMP and GDP regulations, as well as ICH/FDA guidance documents, including experience with development of applicable compliance programs. Knowledge of GLP/GCP regulations
- Understanding of document control requirements in a FDA regulated
- Competent knowledge of and ability to use Microsoft Word and Excel
- Ability for occasional business
- Strong people leadership skills.
- Solid understanding of financials and budgetary management experience.
- Knowledge and understanding of operation of product quality control lab, product quality control requirement and system.
- Shows broad understanding of the issues relevant to the technical/science and business
Preferred:
- Doctorate degree
Wisconsin pay range
$180,000—$210,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
All applicants must have authorization to work in the US for a company.
California Applicant Privacy Policy
Director, Quality Control- CMC
Posted 14 days ago
Job Viewed
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity: Playing a project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within the CMC function, this position will be responsible for overseeing a team and individually contributing to the management of QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP), and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC activities including lifecycle management regulatory submissions such as CBE, PAS, etc. Provide strategic and tactical ownership for QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, including establishment of CDMO and/or CTL. End-to-end process management for analytical purposes in support of manufacturing operations for the release of commercial products. Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs) for release and stability purposes. Manage quality events related to commercial QC testing such as lab investigations (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0), and CAPAs. Support regulatory submissions and lifecycle management to maintain operational compliance. Collaborate with cross-functional teams including CMC RA, DS, DP, Supply Chain, and Quality Assurance to achieve project goals within timelines. Required Skills, Experience, and Education: BS or MS in Chemistry, Pharmaceutical Science, or related discipline. 10+ years of relevant industrial experience in analytical development/QC. Solid understanding of compliance and regulatory requirements related to data integrity, process validation, manufacturing sampling and testing, stability studies, method validation, and transfer. Effective written and verbal communication skills and interpersonal skills. Extensive knowledge of cGMP guidelines and practices, as well as related industry best practices. Strong problem-solving skills with sound technically driven decision-making ability. Excellent communication skills (verbal, written, and technical), strong interpersonal and collaboration skills, and planning skills. Ability to think critically and creatively, work independently, and determine appropriate resources for problem resolution. Ability to multi-task and thrive in a fast-paced, innovative environment. Preferred Skills: Experience in solid oral dosage forms, including dissolution testing. Knowledge and work experience with global regulatory submissions (IND, IMPD, NDA, MAA, etc.) is preferred. Experience in Commercial QC. Chromatographic experience in development, optimization, and troubleshooting. The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed is intended for onsite workers in Redwood City and will be adjusted based on the candidate's location. Salary ranges are determined by role, level, and location, with individual pay influenced by skills, experience, market conditions, and education. Please note that base salary is part of the overall rewards package, which includes competitive cash compensation, equity awards, benefits, and development opportunities. Revolution Medicines is an equal opportunity employer and prohibits discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, medical condition, or veteran status. We prioritize the protection and security of personal data, collecting and processing it in accordance with our CCPA Notice and Privacy Policy . For more information, contact . #LI-Hybrid #LI-CT1 #J-18808-Ljbffr
Sr. Director - Quality Control
Posted 1 day ago
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Job Description
**Organization Overview:**
_Lilly is currently constructing an advanced manufacturing facility for production of APIs (small molecule and peptide) located in Lebanon, IN (Lilly Lebanon API). This facility is Lilly's largest investment in manufacturing capacity and is intended to provide for current and future products, including new modalities. This is a unique opportunity to be a part of the startup team for a greenfield manufacturing site, and the successful candidate will help to build the processes and facility to enable a successful startup into GMP manufacturing operations._
**Main Purpose and Objectives:**
The Senior Director - Quality Control is part of the Senior Leadership Team of the Lilly Lebanon API site (LP1). The QC Senior Director provides administrative and technical leadership in the development, performance, and maintenance of the QC Labs throughout the start-up, implementation, and day-to-day operations of LP1.
The Sr. Dir. - QC must balance coaching a technical staff, prioritization and staffing for routine production support activities, implementation of technical projects, and process optimizations. The position requires knowledge of cGMPs, applicable global regulatory manufacturing guidance, and the corporate/industry standards for validation. The Sr. Dir. - QC will work cross-functionally within the site, network, commercialization teams, and other functions to deliver on technical objectives, specific product business plan, and quality objectives.
In the project delivery and start-up phase of the LP1 site, the Sr. Dir. - QC will be flexible in supporting project delivery, building a new organization, developing and implementing the necessary systems and business processes required to support GMP operations, and building the site culture. This will require significant collaboration, creativity, and resilience as the site grows to a full-scale GMP manufacturing operation.
**Key Responsibilities:**
+ Provide technical leadership, performance management, training and development of staff
+ Maintain a safe work environment
+ Ensure GMP compliance
+ Ensure technical review and approval for documents, including investigations, change controls, regulatory submissions, expert opinions, validations, annual product reviews, manufacturing tickets, procedures, process flow documents, personnel qualification strategies, control strategies, technical studies, etc.
+ Partner within Quality Control and across functional disciplines to influence and implement the technical agenda, site business plan objectives, and GMP Quality Plan objectives
+ Interact with regulators, customers, or other outside stakeholders on business issues or in support of internal and external agency audits
+ Ensure adequate oversight and technical excellence for investigations and complaints
+ Collaborate with site team to develop the strategy for the technical agenda to improve process control, yield, efficiency and productivity for all products within the site portfolio
+ Provide oversight for technical projects to improve process control, capacity, yield, and quality
+ Ensure adequate technical representation and engagement within the site and network governance meetings to influence technical agendas
+ Network globally to share best practices, rationale, and control strategies to ensure harmonization and alignment between sites
+ Engage and influence Pharmaceutical Product Development groups for any applicable technical transfer deliverables for processes related to new molecule entities during each stage of commercialization
**Minimum Requirements:**
+ Bachelor's Degree in scientific disciplines of Chemistry, Biochemistry, Biology, Pharmaceutical Science, Engineering or a related field
+ 10+ of experience in Quality Control and team leadership in a pharmaceutical manufacturing environment
**Additional Preferences:**
+ Ability to influence and lead diverse groups
+ Experience with complex regulatory, business, or technical issues for pharmaceutical manufacturing
+ Strong analytical and quantitative problem-solving skills
+ Experience with Empower software
+ Experience with LIMS implementation and use within a manufacturing environment
+ Experience with statistical analysis of data
+ Technical leadership, administrative and organizational skills
+ Proficiency in delivering highly complex tasks and/or tasks that are highly cross-functional
+ Demonstrated Project Management skills and ability to coordinate complex projects
+ Ability to communicate and influence effectively across functional groups and stakeholders
+ Strategic thinking and ability to balance short term needs with long term business evolution
+ Ability to build relationships with internal and external customers and partners
+ Enthusiasm for changes, team spirit and flexibility
+ Demonstrated ability to learn & apply technical/scientific knowledge
**Additional Information:**
+ Ability to travel (approximately 10-20%)
+ Onsite position
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form ( ) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is
$151,500 - $222,200
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
#WeAreLilly
Associate Director, Quality Control
Posted 2 days ago
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Job Description
**Job Description**
**About the role**
The Associate Director of Quality Control will lead the establishment of a state-of-the-art quality control laboratory. Responsibilities include overseeing its design, construction, qualification, and regulatory approval. Collaborate with global teams to align with Takeda's laboratory-of-the-future strategy, focusing on automation and paperless systems. Hire and train the Quality Control team, eventually overseeing lab operations to support a 24/7 pharmaceutical manufacturing site.
**How you will contribute**
·Lead the planning and execution of a new Quality Control Laboratory startup, ensuring full compliance with regulatory standards.
·Design and implement efficient lab processes and workflows to optimize operational performance and throughput.
·Collaborate cross-functionally with IT, R&D, and Manufacturing to ensure seamless system integration.
·Oversee the selection, validation, and implementation of laboratory automation technologies and LIMS platforms.
·Develop and enforce SOPs that uphold the highest standards of safety and quality.
·Manage resources, timelines, and deliverables to ensure a successful and timely lab launch.
·Recruit, train, and lead a high-performing laboratory team, fostering a culture of excellence and accountability.
·Stay current with industry best practices, emerging technologies, and regulatory developments to drive innovation.
·Develop and manage departmental budgets, ensuring alignment with organizational goals and fiscal responsibility.
·Promote team development, engagement, and retention through effective leadership and mentorship.
·Communicate and present effectively to senior leadership and key stakeholders.
·Supervise and support technical teams in a regulated environment, ensuring operational excellence.
·Lead and support regulatory audits and submissions with confidence and precision.
·Maintain clear and consistent communication with the Site Quality Head regarding quality and safety matters.
**What you bring to Takeda**
·Bachelor's degree in science, engineering, or a related technical field.
·Minimum of 8 years of industry experience, including at least 3 years in a managerial or leadership role.
·Demonstrated expertise in Quality Assurance, Quality Control, and laboratory startup operations.
·Strong working knowledge of FDA regulations, current Good Manufacturing Practices (cGMP), and EU regulatory standards.
·Proven ability to lead teams and thrive in dynamic, fast-paced environments.
·Proficient in assessing quality risks and authorized to approve or reject laboratory results.
·Active participation in global forums to stay informed on industry innovations and best practices.
·Deep understanding of Quality Control and Sterility Assurance, including experience with technical upgrades and system improvements.
·Skilled in applying risk management principles to daily operations and decision-making.
·Ability to safely manage hazardous and biological materials in compliance with safety protocols.
**About our Round Lake Facility:**
Takeda's manufacturing facility in Round Lake, Illinois, is an integral part of Takeda's Plasma Network. Close in proximity to both Chicago and Milwaukee, the state-of-the-art facility specializes in producing Flexbumin through the GALAXY manufacturing process. Flexbumin is albumin, contained in a flexible pouch, for patients who experience a loss of plasma volume from situations such as trauma, surgery, blood loss and burns. Round Lake supplies its product to patients all over the world, with key markets in the U.S., China, and India.
Join us to make a difference.
**What Takeda can offer you:**
+ Comprehensive Healthcare: Medical, Dental, and Vision
+ Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
+ Health & Wellness programs including onsite flu shots and health screenings
+ Generous time off for vacation and the option to purchase additional vacation days
+ Community Outreach Programs and company match of charitable contributions
+ Family Planning Support
+ Flexible Work Paths
+ Tuition reimbursement
**Important Considerations**
At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
+ Work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
+ Need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
+ Work in a cold, wet environment.
+ Work multiple shifts, including weekends, or be asked to work supplemental hours, as necessary.
+ Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
**More about us:**
At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
This posting excludes Colorado applicants.
**Empowering our people to shine:**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
#GMSGQ
#LI-FM1
**Takeda Compensation and Benefits Summary**
We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
**For Location:**
USA - IL - Round Lake Innovation Park
**U.S. Base Salary Range:**
$153,600.00 - $241,340.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job?The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based employees may be eligible for short-term and/ or long-term incentives. U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
**EEO Statement**
_Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law._
**Locations**
USA - IL - Round Lake Innovation Park
**Worker Type**
Employee
**Worker Sub-Type**
Regular
**Time Type**
Full time
**Job Exempt**
Yes
Associate Director Quality Control
Posted 12 days ago
Job Viewed
Job Description
As an Associate Director **,** a typical day might include the following:
+ Support filling operations for any technical support.
+ QC method validation and transfer processes.
+ Maintain open communications with scientist including internal, partner and contract manufacturing organizations.
+ Provide direction to Managers and scientist that support the method development, validation and transfer processes.
+ Coordinate with members of Process Sciences, Manufacturing, QC, Stability, and Business Ops to provide analytical support.
+ Oversee Project Management of Method transfer and validations.
+ Report progress monthly to upper management and reports any deficiencies.
+ Ensures QC Analysts receive proper training.
+ Ensures compliance with applicable cGMP regulations and SOPs, and safety standards are maintained.
+ Oversee investigations atypical and OOS test results as necessary.
This role might be for you if:
+ Looking to join a growing, diverse team that supports other QC teams to achieve continued growth and success.
+ Creative problem solver, effective communicator, goal and achievement motivated.
+ Have experience working with cross-functional teams for analytical development, support and challenges.
+ Customer service focused for internal and external partners.
To be considered for this position you must have a BS/BA in Science, Engineering, or related field, with experience in the pharmaceutical or biotech industry. Previous management experience required. Higher level degree preferred.
+ Associate Director - Requires 10+ years relevant experience
+ Director - Requires 12+ years relevant experience
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.
Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.
**Salary Range (annually)**
$145,600.00 - $237,600.00
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About the latest Director of quality Jobs in United States !
Associate Director / Director, Quality Control
Posted 9 days ago
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Job Description
Company Overview:
Mythic Therapeutics is a privately held product-platform company building a pipeline of best-in-class antibody drug conjugates (ADCs) exhibiting a combination of unprecedented efficacy and therapeutic index. The Company’s FateControl engineering technology dramatically enhances tumor uptake of ADC per dose, thereby safely increasing potency and opening up new therapeutic opportunities against a broad array of tumor targets.
At Mythic Therapeutics, we approach our work as entrepreneurs and innovators, blazing new trails that lead to better patient outcomes. We do so decisively and thoughtfully, drawing upon the decades of experience within our leadership team and scientific advisers. If you share our passion and sense of urgency for developing effective cancer treatment options, and are looking for a dynamic, collaborative, and fulfilling work environment, we invite you to explore opportunities to join our team. Together, we are re-envisioning cancer therapy.
Job Summary:
Mythic Therapeutics is searching for a dynamic AD/Director, Quality Control to join our growing Quality team.
The AD/Director, Quality Control will be responsible for ensuring analytical methods are appropriately qualified and/or validated. Specifications are managed and appropriately set to support the release of clinical and commercial material. Managing the Stability Program for intermediate, Drug Substance, and Drug Product for clinical and intended commercial material. The successful candidate will have a proven track record and hands-on experience building phase appropriate quality systems and a demonstrated ability to work in an entrepreneurial environment in a transitional development environment and understands the requirements for managing analytical methods/QC release tests for late-stage programs. They will possess a “can-do”, execution-oriented mindset. This position will report directly to the VP of Quality.
Key Responsibilities and Opportunities:
As a key member of the Quality Team at Mythic Therapeutics you will:
- Work effectively to establish a relationship with the CMC focused internal and external stakeholders
- Work effectively to establish a relationship with and to perform appropriate oversight of Mythic CMO’s and CTLs as it related to QC functions and responsibilities
- Work cross-functionally to further develop, implement, and improve the Quality Control procedures and Quality Control oversight.
- Review Intermediate, Drug Substance, and Drug Product lot related analytical results and generate Mythic certificate of analysis in support of lot disposition for each material.
- Manage the Stability Program for Intermediates, Drug Substance and Drug Product. Review stability data, provide interim stability and final stability report and manage the process of extending expiration dates based on stability data.
- Work with CMO/CTL to resolve any Quality Events related to analytical testing of lots to enable disposition.
- Work within the Quality QMS system and initiate and/or support any Quality events and/or change controls related to analytical testing.
- Evaluate and propose appropriate QC focused quality systems to enhance and incorporate into Mythic’s Quality Management System.
- Nurture a strong, risk-based, quality compliance culture within Mythic.
- Write and review Quality Control focused SOP’s, protocols and reports.
- Review and revise as applicable the IND and IMPD CMC sections as it related to analytical methods, specifications and stability.
- Lead preparations for regulatory inspections and ensure inspection readiness as it relates to Quality Control at Mythic.
- Keep up to date with all related analytical/quality control -related regulations and guidance as well as relevant industry and best practices.
Minimum Requirements
- Bachelor’s degree in a science discipline (Biology, Chemistry, Biochemistry or similar) with at least 10 years of Quality Control/Analytical experience in the Biotech/Pharmaceutical Industry; at least 5 years of experience as lead QC.
- Thorough knowledge of all facets of GxP regulations, ICH guidelines and industry standards
- Ability to work cross functionally in a team environment
- Proven skills and track record of leading, and developing Quality Control function within the pharmaceutical or biotechnology industry
- Extensive experience with biological manufacturing and testing
- Experience with ADC’s a plus
- Ability to deliver under tight timelines
Personal Characteristics and Cultural Fit:
- Good judgement : Strong problem solving, critical thinking and analytical skills required to make evidence-based decisions. Good judgment, level-headed, neutral, and objective.
- Builds Relationships and Culture : Reputation for creating strong team cultures of quality, trust, and collaboration. Skilled at building and managing relationships cross-functionally and with external collaborators/partners, consultants, and vendors.
- Excellent written and oral communication skills
- Influences : Highly credible with various stakeholder group (internal employees up-down and across the organization, external collaborators, partners, and vendors and with site teams and investigators). Skilled at building and cultivating stakeholder confidence
- Execution mindset: Self-starter with a can-do mindset and do what is needed to advance the company’s programs and initiatives. Drives self, individual and team accountability, develops and implements goals, objectives, measurable targets, and processes to achieve results.
- Demonstrated ability to work in a fast-paced, innovative biotech environment.
Location
Highly preferable to be based in the Boston area, or willing to relocate. This is a hybrid position 3 days in the office and 2 days remote
Mythic Therapeutics offers a fast-paced, entrepreneurial, team-focused work environment. We also offer a top-notch benefits package and work/life integration. Being part of the Mythic team allows you to become part of a small team that supports professional development while working together to meet the company goals.
Director, Quality Control- CMC (San Francisco)
Posted 3 days ago
Job Viewed
Job Description
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding scientists in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Playing a project leading role and Subject Matter Expert (SME) of late phase and commercial Quality Control within the CMC function, this position will be responsible for overseeing a team and individually contributing to the management of QC activities from process validation to commercial launch readiness supports of drug substance (DS), drug product (DP), and final product (FP) manufacturing. The candidate will also be responsible for post-approval QC activities including lifecycle management regulatory submissions such as CBE, PAS, etc.
Provide strategic and tactical ownership for QC activities of late phase and commercial programs, including but not limited to commercial launch readiness, including establishment of CDMO and/or CTL.
End-to-end process management for analytical purposes in support of manufacturing operations for the release of commercial products.
Oversee and manage outsourced commercial QC activities at CDMOs and/or contract testing labs (CTLs) for release and stability purposes.
Manage quality events related to commercial QC testing such as lab investigations (e.g., OOS/OOT), deviations, change controls (e.g., CBE 30/CBE 0), and CAPAs.
Support regulatory submissions and lifecycle management to maintain operational compliance.
Collaborate with cross-functional teams including CMC RA, DS, DP, Supply Chain, and Quality Assurance to achieve project goals within timelines.
Required Skills, Experience, and Education:
BS or MS in Chemistry, Pharmaceutical Science, or related discipline.
10+ years of relevant industrial experience in analytical development/QC.
Solid understanding of compliance and regulatory requirements related to data integrity, process validation, manufacturing sampling and testing, stability studies, method validation, and transfer.
Effective written and verbal communication skills and interpersonal skills.
Extensive knowledge of cGMP guidelines and practices, as well as related industry best practices.
Strong problem-solving skills with sound technically driven decision-making ability.
Excellent communication skills (verbal, written, and technical), strong interpersonal and collaboration skills, and planning skills.
Ability to think critically and creatively, work independently, and determine appropriate resources for problem resolution.
Ability to multi-task and thrive in a fast-paced, innovative environment.
Preferred Skills:
Experience in solid oral dosage forms, including dissolution testing.
Knowledge and work experience with global regulatory submissions (IND, IMPD, NDA, MAA, etc.) is preferred.
Experience in Commercial QC.
Chromatographic experience in development, optimization, and troubleshooting.
The base salary range for this full-time position is $204,000 to $255,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed is intended for onsite workers in Redwood City and will be adjusted based on the candidate's location. Salary ranges are determined by role, level, and location, with individual pay influenced by skills, experience, market conditions, and education.
Please note that base salary is part of the overall rewards package, which includes competitive cash compensation, equity awards, benefits, and development opportunities.
Revolution Medicines is an equal opportunity employer and prohibits discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin, age, disability, marital status, medical condition, or veteran status.
We prioritize the protection and security of personal data, collecting and processing it in accordance with our CCPA Notice and Privacy Policy . For more information, contact .
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#J-18808-LjbffrDirector of Quality Control
Posted 5 days ago
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Job Description
Our client is looking for a Director of Quality who oversees and executes the company's overall quality program. Responsibilities manage a multidisciplinary team, covering food safety, food quality, sanitation, and regulatory compliance at the manufacturing/warehouse level with a focus on continuous improvement. JOB DUTIES AND RESPONSIBILITIES: Ensure manufacturing site is producing safe, quality food that meets the needs and requirements of our customers, stakeholders, and regulatory agencies (audit ready, every day) Ensure sites are maintaining high sanitary standards through the execution of effective Sanitation Operating Procedures and Master Cleaning Schedules. Provide site teams with assistance in managing customer relations including site audit preparation & facilitation as needed Ensure that site teams are effectively managing customer complaints with thorough root cause investigation, effective CAPA plans and timely and meaningful responses Ensure all food safety and quality management programs are effectively implemented and executed Manage team developmental plans and performance issues Develop, manage, and improve key performance metrics Partner cross-functionally to ensure that FSQA is built into all processes Lead change and improve ways of working Mitigate risk through the application of scientific principles, technical experience and employment of Quality and Food Safety Standards Troubleshoot problems associated with product and process industrialization across all facilities; ensure root cause/corrective actions are appropriate and are fully implemented Collaborate with internal functions including Operations, Maintenance/Engineering, Research & Development, Environmental Health and Safety, Operational Excellence, Regulatory, and Commercialization to deliver products to the market that meet company standards Utilize Six Sigma, Lean, and/or other continuous improvement concepts to improve quality, efficiency, and waste Ensure quality teams are effectively testing inbound ingredients to ensure quality, safety and supplier accountability and compliance to established specifications Ensure quality teams are effectively testing finished products to ensure adherence to product specifications and quality standards Stay current with all regulatory and certifying agency guidelines Manage regulatory issues across the company All other duties as assigned REQUIREMENTS: Demonstrated excellence in achieving process improvements and associated operating efficiencies from the application of “LEAN / Six Sigma” operational excellence thinking and toolset Expert understanding of Quality Systems, Food Safety, Quality Assurance and Food Regulations People management experience including coaching, performance reviews, and career development Ability to understand technical and scientific concepts Experience in high-volume, automated food manufacturing Ability to work under deadlines, with multiple priorities Ability to work cross-functionally within the organization Must be adaptable, flexible and comfortable in a change management role Self-driven, results-oriented, and able to work independently Excellent communication/presentation skills Detail-oriented - Excellent record-keeping/documentation skills Able to quickly learn new systems, tools, and programs Experience with 3rd party audits Working knowledge of ERP systems electronic food safety/quality document management systems Compensation: $140,000 plus benefits If this sounds like the position you have been waiting for, please apply using the online application or the link below - all inquiries are strictly confidential. Our focus is to assist you to make your best next career move, and we will not use your information for any other purpose. Kalon Staffing is an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. #J-18808-Ljbffr