Manufacturing Investigator

27835 Greenville, North Carolina Actalent

Posted 12 days ago

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Job Description

Job Title: Manufacturing Investigator
Job Description
The Deviation Investigator is tasked with identifying, documenting, investigating, and resolving deviations from standard procedures, protocols, or regulatory requirements. This role is pivotal in ensuring that all deviations are managed in compliance with company policies and industry regulations, and that corrective and preventive actions (CAPAs) are implemented effectively.
Responsibilities
+ Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines.
+ Conduct thorough investigations to determine the root cause of deviations.
+ Collaborate with cross-functional teams to develop and implement corrective and preventive actions (CAPAs).
+ Maintain accurate and detailed records of all deviations, investigations, and corrective actions.
+ Present deviation reports to management and regulatory authorities as required.
+ Ensure documentation is completed in accordance with Good Documentation Practices (GDP).
+ Ensure all deviations are managed in compliance with company policies, industry standards, and regulatory requirements.
+ Participate in internal and external audits and inspections, providing necessary documentation and information related to deviations.
+ Analyze deviation trends and provide insights for continuous improvement initiatives.
+ Participate in training programs to enhance knowledge and skills related to deviation management and quality assurance.
Essential Skills
+ At least 2 years of experience in a pharmaceutical environment conducting investigations.
+ Strong analytical and problem-solving skills, with proficiency in root cause analysis using methods such as fishbone and 5 whys.
+ Proven experience in technical writing, particularly in writing investigations.
Additional Skills & Qualifications
+ Knowledge of Good Manufacturing Practices (GMP).
+ Experience in process improvement.
Work Environment
The role operates within a typical office environment, with working hours from Monday to Friday, 8:00 am to 5:00 pm. The hiring manager offers flexibility in the schedule. Expectation of 10 hours per week of overtime. Interviews will be conducted face-to-face.Manufacturing
Pay and Benefits
The pay range for this position is $50.00 - $50.00/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
- Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in Greenville,NC.
Application Deadline
This position is anticipated to close on Aug 25, 2025.
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email (% ) for other accommodation options.
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Scientist II, Manufacturing Sciences - Continuous Manufacturing

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 3 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us and Make a Difference!**
At Thermo Fisher Scientific, your work will make a global impact. From protecting the environment to ensuring food safety and supporting life-saving cancer research, we address the world's toughest challenges.
**About The Role:**
We are looking for a dedicated Manufacturing Scientist to support the development and advancement of manufacturing processes for oral solid dosage (OSD) products in both traditional batch and continuous manufacturing environments. You will contribute to scaling up new processes, performing product validations and post-approval qualifications, and supporting routine manufacturing operations to ensure timely product release. You will collaborate closely with analytical, quality, and project management teams to drive successful process development and commercial execution.
**Key Responsibilities:**
+ Collaborate with cross-functional teams-including validation, operations, quality, analytical development, and process development-to support technical project activities.
+ Contribute scientific input to product and process development efforts within commercial manufacturing areas.
+ Assist in applying risk-based approaches to process scale-up and commercialization, supporting the development of mitigation strategies.
+ Draft and review batch records, protocols, and reports to support development, validation, and commercial production activities.
+ Support routine manufacturing operations by troubleshooting issues and ensuring timely product release, while building technical expertise as a product steward.
**Education**
Bachelor's degree in chemical engineering, chemistry, pharmacy, or a related field with 1+ years of experience, Master's degree or Ph.D. with no experience required.
**Experience**
+ Minimum of 1 year of experience in a pharmaceutical manufacturing or process development environment, including exposure to scale-up, technology transfer, or commercial support for immediate and controlled-release dosage forms; familiarity with continuous manufacturing is a plus.
+ Foundational understanding of GMP, regulatory expectations, and process validation principles.
+ Ability to contribute to cross-functional projects in a fast-paced, results-driven setting, with emerging skills in navigating compliance-related activities.
+ Solid understanding of Python or MATLAB for data analysis, along with basic proficiency in statistical tools relevant to process development.
+ Strong communication, problem-solving, and teamwork skills, with the potential to contribute to internal and client-facing technical discussions.
**Why Thermo Fisher Scientific?**
+ Career Development: Opportunities for learning, growth, and leadership.
+ Benefits: Competitive pay, healthcare, retirement plans, and more.
+ Inclusive Culture: We value different perspectives and cultivate an encouraging environment.
+ Purposeful Work: Join a team that's making a tangible difference in the world.
Do you thrive in dynamic environments and love solving sophisticated challenges? If so, we want to hear from you.
**Reasonable Accommodations**
We are committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process, please contact our HR team.
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Scientist III, Manufacturing Sciences - Continuous Manufacturing

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 3 days ago

Job Viewed

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Join Us and Make a Difference!**
At Thermo Fisher Scientific, your work will make a global impact. From protecting the environment to ensuring food safety and supporting life-saving cancer research, we address the world's toughest challenges.
**About The Role:**
We are seeking a dedicated Manufacturing Scientist to support the development of oral solid dosage (OSD) manufacturing processes in both batch and continuous manufacturing environments. Responsibilities include scaling up new processes, performing product validations and post-approval qualifications, and supporting routine operations to ensure timely product release. You may serve as the primary technical representative on client projects and will collaborate closely with analytical, quality, and project management teams to drive successful process development and commercialization. Experience with data science or statistical tools (e.g., Python, MATLAB) to support process optimization is desirable.
**Key Responsibilities:**
+ Collaborate with cross-functional teams to complete technical activities and provide scientific support for product and process development in commercial manufacturing.
+ Lead technical planning and serve as the primary scientific representative in client interactions, providing rationale for decisions and ensuring alignment across multiple projects.
+ Apply a risk-based approach to process scale-up and commercialization, developing and implementing mitigation strategies.
+ Prepare batch records, protocols, and reports to support development, validation, and routine commercial production.
+ Support routine manufacturing and act as technical steward for assigned products.
**Education**
Bachelor's degree in chemical engineering, chemistry, pharmacy, or a related field with 2+ years of experience, Master's degree or Ph.D. with no experience required.
**Experience**
+ Proven experience in a pharmaceutical manufacturing environment, with hands-on experience in product or process development, including scale-up and technology transfer for immediate and controlled-release dosage forms; knowledge of continuous manufacturing is preferred.
+ Strong understanding of GMP, regulatory compliance, and process validation requirements.
+ Demonstrated capability in coordinating complex projects and handling compliance-related obstacles in a fast-paced environment.
+ Proficient in Python or MATLAB for data analysis, with solid knowledge of statistical tools and their application to process development.
+ Excellent problem-solving, communication, and collaboration skills, with the ability to lead technical discussions across cross-functional teams and with external clients.
**Why Thermo Fisher Scientific?**
+ Career Development: Opportunities for learning, growth, and leadership.
+ Benefits: Competitive pay, healthcare, retirement plans, and more.
+ Inclusive Culture: We value different perspectives and cultivate an encouraging environment.
+ Purposeful Work: Join a team that's making a tangible difference in the world.
Do you thrive in dynamic environments and love solving sophisticated challenges? If so, we want to hear from you.
**Reasonable Accommodations**
We are committed to providing reasonable accommodations to individuals with disabilities. If you require assistance during the application process, please contact our HR team.
Thermo Fisher Scientific is an Equal Opportunity Employer. We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Manufacturing Production Operator

27835 Greenville, North Carolina Catalent Pharma Solutions

Posted 4 days ago

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Job Description

**Manufacturing Production Operator**
**Position Summary**
Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development. 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 Manufacturing Production Operator is responsible for cleaning equipment as well as dispensing, sifting, and blending of good manufacturing practice (GMP) commercial batches in an oral solid dosage (OSD) environment. 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.
Shift: Monday - Thursday 4 pm - 2:30 am
This position is 100% on-site at the Greenville site.
**The Role**
+ With close oversight, operate equipment needed to dispense and sift scale-up, bio-batches, full commercial scale batches, and CTM batches.
+ Ensure all batch records and logbook entries are accurately documented and compliant with SOPs and FDA cGMP guidelines.
+ Assist with setup, manufacturing, and changeovers with adherence to SOPs and safety requirements.
+ All other duties as assigned.
**The Candidate**
+ High school diploma or equivalentwith at least 1 year of manufacturing or related experience or completion of Grads2Work Program or BioWorks certificate program required.
+ Required to obtain internal forklift operation certification.
+ Position requires the ability to lift 50 lbs unassisted, and push and pull in excess of 100 lbs.
+ Majority of work day is performed while standing and walking.
+ Requires the use of hands for simple grasping and fine manipulations.
+ Ability to occasionally bend, stoop, twist, and have full range of motion in upper and lower extremities.
+ Exposure to hazardous chemicals, other active chemical ingredients, dust, fumes, gases, skin and respiratory irritants, moving machinery parts, and damp, humid and wet environments.
+ Must be able to use a variety of tools, equipment, and machinery.
+ This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
**Why You Should Join Catalent**
+ Competitive medical benefits and 401K
+ 152 hours of PTO + 8 Paid Holidays
+ Dynamic, fast-paced work environment
+ Opportunity to work on Continuous Improvement Processes
**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 ( .
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Pharmaceutical Manufacturing Specialist

27835 Greenville, North Carolina Catalent Pharma Solutions

Posted 4 days ago

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Job Description

**Pharmaceutical Manufacturing Specialist**
**Position Summary**
Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
The Pharmaceutical Manufacturing Specialist has a primary focus on new technology and business moving into Commercial Manufacturing Operations as well as serves as a liaison with other functional teams to lead/support commercial manufacturing operations and cross-functional execution. The Pharmaceutical Manufacturing Specialist provides on-the-floor oversight, direction, and support to manufacturing personnel to ensure timeliness and accuracy in the completion of assigned work. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 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.
**Shift:** Monday - Thursday 4 pm - 2:30 am
This position is 100% on-site at the Greenville site.
**The Role**
+ Frontline interface between the Commercial Manufacturing team, internal support teams as well as external clients to lead/support project work requiring cross-functional support. Assist in Commercial, Technical Transfer, Engineering and Development batches.
+ Maintain the inventory system for raw materials components; train and assist others in the use of the inventory system.
+ Assist in decisions on equipment selection, placement, and procedures to use equipment most effectively.
+ Ensure manufacturing area and equipment are maintained in accordance with company and regulatory requirements.
+ Recognize potential problems and provide input on corrective action(s), assist in completion of resolutions for issues in Commercial Manufacturing Operations.
+ Identify and recommend opportunities for improved efficiencies, client service and teamwork within Commercial Manufacturing Operations.
+ Troubleshoot equipment, process issues, and escalate problems that require quality assurance or Maintenance involvement; provide leadership and support for the timeliness and accuracy in the completion of Commercial Manufacturing operations.
+ Support and occasionally lead under supervision the scheduling and planning of client project work to ensure the highest levels of efficiency and quality standards are met.
+ Other duties as assigned.
**The Candidate**
+ High school diploma or equivalent with at least 5 years of experience in pharmaceutical Oral Solid Dosage (OSD) manufacturing required OR
+ Associate degree with at least 4 years of experience in pharmaceutical Oral Solid Dosage (OSD) manufacturing.
+ Demonstrated proficiency in Oral Solid Dosage (OSD) manufacturing operations related to Dispensing, Granulation, Compressing/Encapsulation and Coating. Must have previous experience with inventory management systems and be able to learn QAD (inventory Management System) to assist in the timely start and completion of batches and documentation.
+ This position requires that a respirator be worn for your safety, and as such, employment is contingent upon being able to complete a medical evaluation with satisfactory results. The medical evaluation is conducted via an external vendor assigned by Catalent.
+ Position requires the ability to lift 50 lbs. unassisted, and push and pull in excess of 100 lbs.
**Why You Should Join Catalent**
+ 152 hours of PTO + 8 paid holidays.
+ Medical, dental and vision benefits effective day one of employment.
+ Defined career path and annual performance review and feedback process.
**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 ( .
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Sr Manager, Continuous Manufacturing

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 8 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Job Summary:**
Leads the Manufacturing Sciences Teams and provides strategic direction and mentorship in the areas of manufacturing processes and technology, process improvement, quality performance and formulation development.
Lead and coordinate Operations for the Continuous Manufacturing Dept. Provide technical and managerial mentorship while implementing operational strategies. Collaborate with business unit leaders to support overall client and business unit goals.
Essential Functions
+ Provides leadership to assigned staff through leading organizational change, empowerment, cultivates relationships; helps them achieve their personal career goals while also achieving organizational goals.
+ Builds effective teams that apply their diverse skills and perspectives to achieve common goals; driving engagement and creating a climate where staff are motivated to do their best.
+ Ensures the rapid development of new dosage forms and processes according to customer requirements. Assures that processes are safe, reproducible, cost effective, environmentally sound and can be successfully validated and transferred to production operations, in order to meet agreed standards and require minimal continuing support.
+ Defines resource needs (capital, expense, and headcount) so that current and future development needs are met. Recruits, hires, retains, trains, and motivates a scientifically proficient staff. Provides opportunities for staff career development.
+ Ensure all production operations and equipment are controlled, validated, and in regulatory compliance and appropriate Standard Operating Procedures (SOPs) and batch record documents exist and are followed and reviewed regularly.
+ Technical representation on new business quotes and senior-level client visitors and inter-site visitors. Leads development and coordination of realistic proposals and timelines, reviews technical packages. Leads meetings/teleconferences with clients.
+ Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices and Safety guidelines.
+ Works with Client Departments to introduce new technology and resolve complex OSD problems related to both existing portfolio and development work.
+ Leads research of industry practices and processes and applies to innovative drug development internally and for client products. Presents recommendations internally and to clients. Publicizes research, scientific reports and white papers. Represents the organization on formal technical and scientific forums.
+ Recommends and assists in implementing organizational and technical improvements designed to enhance the efficiency, reliability, and productivity of operations all conforming to applicable regulatory standards.
+ Tracks quality performance trends and keeps Corrective Action Preventative Action (CAPA) actions on track.
**Education:**
+ PHD in engineering or relevant physical science is preferred
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, or related physical science required.
**Experience:**
+ Minimum 5 years of Oral solid dose manufacturing experience
+ Minimum 5 years of management experience
+ Minimum 10 years of progressive scientific experience, including 9 years in a related life sciences field.
+ Experience working directly with clients
+ Previous Continuous Manufacturing Experience preferred
+ Experience with Process Analytical Technology ( **PAT** ) preferred
**Equivalency:**
Equivalent combinations of education, training, and meaningful work experience may be considered.
**Competencies:**
Ability to drive functional, technical and operational excellence.
Ability to inspire and champion innovation, collaboration, transparency and team effectiveness.
Exceptional Good Manufacturing Practices knowledge.
Demonstrated decision making capabilities.
Strong leadership and conflict resolution skills.
Consistent track record to balance/maintain goals, responsibilities, and priorities of the organization.
Demonstrated success as agent of change.
Excellent interpersonal and communication skills, as well as the ability to empower and lead.
Working knowledge of Microsoft (MS) Office Applications (Word, Excel, PowerPoint, Share point)
Proficiency with the English language.
Demonstrated commitment to our fundamental principles of Integrity, Respect & Excellence.
**Physical Requirements:**
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
Relocation assistance is NOT provided.
Must be legally authorized to work in the United States without sponsorship, now or in the future.
Must be able to pass a comprehensive background check, which includes a drug screening.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Director, Manufacturing Science and Technology

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 3 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Office
**Job Description**
**Position: Director, Manufacturing Science and Technology (MSAT)**
**Reports To: Site Vice President and General Manager**
**Location: Greenville, NC**
**How will you make an impact?**
The MSAT Director provides scientific leadership to ensure compliance, resilience & competitiveness of Thermo Fisher's commercialized Grow, Value Optimization and Late Lifecycle portfolio.
The successful candidate is a Subject Matter Expert (SME) in Large and Small Molecule Drug Products and directs a team of Molecular Biologists, Chemical & Process Engineers, and Scientists. This team leads strategic, tactical and operational technical projects for the commercialized product portfolio, working closely with operations, QA, QC, and various supply chain and development functions. This role builds strong partnerships with functions such as Sales, Business Marketing, Quality, Planning, Regulatory, Procurement etc.
This leader has a strong scientific background and drives successful commercialization of the current and future portfolio. They ensure successful New Product Introduction by prioritizing resources. The team manages Life Cycle Management projects, such as supply chain resilience, process optimization, and innovative improvements for efficiency, competitiveness, compliance, and health authority advocacy.
The Director possesses a strong approach for people leadership and talent development resulting in the continuous uplift in team technical capability and project delivery excellence.
**What will you do?**
Own the site's technical continuous improvement strategy in collaboration with Site Leadership.
Encourage a team supporting projects at all stages of the product life cycle, delivering the following aspects:
+ Budget responsibility for team and related activities
+ Define and own lab experiments
+ Post PPQ, full ownership of all continuous process validation activities
+ Lead and coordinate large-scale technical projects from initiation to completion, defining scope, objectives, actions, timelines, and budget, and collaborating with cross-functional teams for successful execution.
Prioritize projects to support supply chain and the value optimization targets.
Lead strategic change management initiatives, engaging and influencing key partners at all levels of the organization. Develop and implement communication plans for successful adoption and implementation.
**How will you get here**
+ Master's degree in engineering, science, or a related field, or PhD.
+ 10 years of expertise in pharmaceutical processes, including DP characterization, stability profile understanding, and linking DP characteristics with bio-pharmaceutical performance.
+ A minimum of 5 years people leader experience, including technical and non-technical coaching and mentoring.
+ Knowledge and experience with both current and new technologies in chemical synthesis, biologics, and new modalities.
+ Strong Experience and track record in technical transfer activities in commercial and clinical space to favor agility and fast time to market in a high VUCA environment (volatile, uncertain, ambiguous).
+ Track record of translating innovative ways into problem solutions and the timely project advancement.
+ Applied critical thinking and vision for the future with a strong record of analyzing and interpreting sophisticated situations to provide clear direction.
+ Effective communicator with experience in teamworks and interactions, building positive relationships with customers, including connections to academic and industry networks.
**About Thermo Fisher Scientific**
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are advancing life sciences research, solving complex analytical challenges, optimizing efficiency in their laboratories, optimizing patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our distributed team of over 130,000 colleagues presents a ground-breaking blend of powerful technologies, user-friendly purchasing options, and pharmaceutical services across our top brands like Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD. For more information, please visit ( .
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here ( for further assistance!
_Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Manufacturing Scientist III (Technology Transfer)

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 4 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Role Overview**
Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare necessary documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification as needed and update status of project work.
**Discover Impactful Work!**
+ Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
+ Leads technical/scientific process/product/project activities to implement strategies and technical solutions.
+ Drives creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
+ Makes decisions that involve direct application of technical knowledge.

**A Day in the Life.**
+ Design, implement, and evaluate studies, lead tech transfer, commercial scale-up and support process validation.
+ Represent the organization on formal technical and scientific forums.
+ Lead and/or participate in problem solving and project work for formulations, equipment and processes.
+ Write/revise work orders for new processes, FORMs, reports, memos, and protocols as required.
+ Independently manage projects, proficient in evaluating and organizing all technical aspects of the project to achieve necessary landmarks and turning points.
+ Support manufacturing operations, change controls, investigations as subject matter expert (SME), resolve accurate CAPAs.
+ Assess material changes and determine change impact.
+ Support development of proposals and timelines for projects, leading relevant client meetings.
+ Review new bid quotes, protocols, technical documents, results, and reports.
**Keys to Success**
**Education:**
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical or related physical science.
**Experience:**
+ Bachelors and 3+ years confirmed experience
+ CMO or Pharmaceutical product development experience PREFERRED
**Equivalency:**
Equivalent combinations of education, training, and meaningful work experience may be considered.
**Knowledge, Skills, Abilities:**
+ Advanced knowledge of variety of aspects of a subject area and working knowledge of principles and concepts in other relevant technical subject areas.
+ Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
+ Detailed knowledge of Good Manufacturing Practices.
+ Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
+ Effective written, interpersonal, and presentation skills, including leading technical discussions with internal and external clients.
+ Ability to work on multiple projects simultaneously.
+ Proficiency at developing knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
+ Capability to keep current with scientific literature and industry trends relating to process technologies.
+ Ability to develop technical solutions.
+ Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Manufacturing Scientist II (Technology Transfer)

27835 Greenville, North Carolina ThermoFisher Scientific

Posted 4 days ago

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Job Description

**Work Schedule**
Standard (Mon-Fri)
**Environmental Conditions**
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
**Job Description**
**Job overview**
Complete Technology Transfer activities by performing manufacturing process development for Injectables products to commercial lines. Using experimental design, establish formulation processes, product pathway and select components for successful scaleup. Support client calls, prepare documentation (including but not limited to work orders, protocols, summaries, with minimum supervision), and provides scientific justification and update status of project work as needed.
**Discover Impactful Work!**
+ Technically supports day-to-day operations in the Formulation, Filling, and/or Freeze Drying areas of the Steriles plant.
+ Works on technical/scientific process/product/project activities to implement strategies and technical solutions.
+ Assists in the creation of processes, single use systems, and equipment designs for clinical, scale up, and/or registration batches, including technology transfer of projects from clients.
+ Makes decisions that involve direct application of technical knowledge.
**A Day in the Life.**
+ Complete studies, tech transfer, commercial scale-up and support process validation.
+ Represent the organization on internal technical discussions.
+ Actively participate in problem solving and project results for formulations, equipment and processes.
+ Write/revise work orders for existing processes, FORMs, reports, memos, and protocols.
+ Lead projects with a moderate level of supervision, implement change control actions, review and plans technical aspects of the project to meet timeline and project goals.
+ Support manufacturing operations, change controls, investigations as subject matter expert (SME).
+ Collects data for statistical analysis. Can support interpretation and summary of data.
**Keys to Success**
**Education:**
+ Bachelor's of Science in Chemistry, Biochemistry, Biology, Pharmaceutical, Engineering or related physical science.
**Experience:**
+ Bachelors and 2+ years of related experience, or, related Master's degree.
+ Experience in a CMO or Pharmaceutical product development field PREFERRED.
**Equivalency:**
+ Equivalent combinations of education, training, and meaningful work experience may be considered.
**Knowledge, Skills, Abilities:**
+ Excellent knowledge of scientific methodology and development as related to the pharmaceutical industry.
+ Detailed knowledge of Good Manufacturing Practices.
+ Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint). Excellent critical and logical thinking skills.
+ Effective written, interpersonal, and presentation skills, including running technical discussions with internal and external clients.
+ Ability to work on multiple projects simultaneously.
+ Ability to acquire knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
+ Ability to keep current with scientific literature and industry trends relating to process technologies.
+ Ability to run technical solutions.
+ Position requires ordinary ambulatory skills and physical coordination sufficient to move about office locations; ability to stand and walk; ability to lift and/or carry light objects of up to 25 lbs. for brief periods.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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Industrial Project Manager - Chemical/Manufacturing Facilities

27835 Greenville, North Carolina CDM Smith

Posted 3 days ago

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Job Description

**41941BR**
**Requisition ID:**
41941BR
**Business Unit:**
IND
**Job Description:**
CDM Smith is seeking a Project Manager to lead and manage multiple small to large consulting, environmental compliance, design, and design-build Chemical and manufacturing facilities projects for multiple major clients in the domestic United States. This position is part of our Industrial Division, which serves Oil & Gas, Chemicals, Food & Beverage. Metals & Mining, Utility, Manufacturing and other industrial clients. As a member of this team, you would contribute to CDM's mission by:
- Managing multiple large complex engineering projects concurrently within the Chemicals, Petrochemicals, and Downstream Oil and Gas sectors from early concept development through detailed design and construction
- Serving as a mentor and leader of multi-discipline project teams
- Performing technical problem solving
- Leading and managing multi-discipline teams
- Performing guidance and review at the project level while assuring discipline and quality standards are adhered to
- Leading proposal teams and developing project approaches that lead to project wins
- Applying experience and innovation to solve problems of high complexity in area of expertise
- Effectively working with lead practitioners, quality managers, and key technical specialists
- Preparing and monitoring project budgets and schedules in conjunction with assisting in negotiation of contracts and amendments
- Identifying opportunities with existing clients, particularly by expanding service offerings
For more information about our Project Management roles, tools and culture, please visit this website Title:**
Industrial Project Manager - Chemical/Manufacturing Facilities
**Group:**
IND
**Employment Type:**
Regular
**Minimum Qualifications:**
Bachelor's Degree. 10 years of related experience. PMP (PMI), CCM or DBIA certification is required (within 12 months of hire or promotion onto the Approved Project Manager list). Domestic and/or international travel may be required. The frequency of travel is contingent on specific duties, responsibilities, and the essential functions of the position, which may vary depending on workload and project demands. Equivalent additional directly related experience will be considered in lieu of a degree.
**Preferred Qualifications:**
- Bachelor's degree in Engineering or related field
- Registered Professional Engineer (PE)
- Experience managing facilities infrastructure and/or environmental projects for chemicals or manufacturing clients
- Proven experience managing preparation of engineering design packages for construction
- Experience managing project scope, schedule, and budgets
- Exemplary skills in communicating project findings to technical and nontechnical audiences
**EEO Statement:**
We attract the best people in the industry, supporting their efforts to learn and grow. We strive to create a challenging and progressive work environment. We provide career opportunities that span a variety of disciplines and geographic locations, with projects that our employees plan, design, build and operate as diverse as the needs of our clients. CDM Smith is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, pregnancy related conditions, childbirth and related medical conditions, sexual orientation, gender identity or gender expression), national origin, age, marital status, disability, veteran status, citizenship status, genetic information or any other characteristic protected by applicable law.
**Why CDM Smith?:**
Check out this video and find out why our team loves to work here! ( Us! CDM Smith - where amazing career journeys unfold.**
Imagine a place committed to offering an unmatched employee experience. Where you work on projects that are meaningful to you. Where you play an active part in shaping your career journey. Where your co-workers are invested in you and your success. Where you are encouraged and supported to do your very best and given the tools and resources to do so. Where it's a priority that the company takes good care of you and your family.
Our employees are the heart of our company. As an employer of choice, our goal is to provide a challenging, progressive and inclusive work environment which fosters personal leadership, career growth and development for every employee. We value passionate individuals who challenge the norm, deliver world-class solutions and bring diverse perspectives. Join our team, and together we will make a difference and change the world.
**Job Site Location:**
United States - Nationwide
**Agency Disclaimer:**
All vendors must have a signed CDM Smith Placement Agreement from the CDM Smith Recruitment Center Manager to receive payment for your placement. Verbal or written commitments from any other member of the CDM Smith staff will not be considered binding terms. All unsolicited resumes sent to CDM Smith and any resume submitted to any employee outside of CDM Smith Recruiting Center Team (RCT) will be considered property of CDM Smith. CDM Smith will not be held liable to pay a placement fee.
**Amount of Travel Required:**
10%
**Assignment Category:**
Fulltime-Regular
**Visa Sponsorship Available:**
No - We will not support sponsorship, i.e. H-1B or TN Visas for this position
**Background Check and Drug Testing Information:**
CDM Smith Inc. and its divisions and subsidiaries (hereafter collectively referred to as "CDM Smith") reserves the right to require background checks including criminal, employment, education, licensure, etc. as well as credit and motor vehicle when applicable for certain positions. In addition, CDM Smith may conduct drug testing for designated positions. Background checks are conducted after an offer of employment has been made in the United States. The timing of when background checks will be conducted on candidates for positions outside the United States will vary based on country statutory law but in no case, will the background check precede an interview. CDM Smith will conduct interviews of qualified individuals prior to requesting a criminal background check, and no job application submitted prior to such interview shall inquire into an applicant's criminal history. If this position is subject to a background check for any convictions related to its responsibilities and requirements, employment will be contingent upon successful completion of a background investigation including criminal history. Criminal history will not automatically disqualify a candidate. In addition, during employment individuals may be required by CDM Smith or a CDM Smith client to successfully complete additional background checks, including motor vehicle record as well as drug testing.
**Pay Range Minimum:**
$119,829
**Pay Range Maximum:**
$209,726
**Additional Compensation:**
All bonuses at CDM Smith are discretionary and may or may not apply to this position.
**Work Location Options:**
Hybrid Work Options may be considered for successful candidate.
**Massachusetts Applicants:**
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
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