127 Biopharmaceutical jobs in the United States

Join a leading biopharmaceutical company in Huntsville, Alabama as a Lead Biopharmaceutical Process Engineer. This role is critical in the development, optimization, and scale-up of innovative biomanufacturing processes for novel therapeutic proteins and vaccines. You will be instrumental in ensuring the efficiency, robustness, and regulatory compliance of our upstream and downstream manufacturing operations. The successful candidate will possess a Master's or Ph.D. in Chemical Engineering, Biochemical Engineering, or a related discipline, with a minimum of 7 years of experience in the biopharmaceutical industry. Responsibilities include designing and executing process development studies, performing risk assessments, and leading technology transfer activities from pilot scale to commercial manufacturing. You will troubleshoot complex process issues, implement process analytical technology (PAT), and stay abreast of emerging trends in bioprocessing, such as continuous manufacturing and single-use systems. This position demands strong analytical and problem-solving skills, a thorough understanding of GMP guidelines, and experience with cell culture, chromatography, filtration, and sterile fill-finish operations. Proficiency in process simulation software (e.g., Aspen Plus, SuperPro Designer) and statistical analysis tools (e.g., JMP, Minitab) is required. As a lead engineer, you will mentor junior team members, manage project timelines, and collaborate effectively with cross-functional teams including R&D, Quality Assurance, and Regulatory Affairs. We are looking for an individual with exceptional leadership qualities, excellent communication skills, and a passion for bringing life-saving medicines to patients worldwide. This is a unique opportunity to shape the future of biopharmaceutical manufacturing and contribute to impactful scientific advancements.

Job Description

Job Description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the clients facilities.

This role is forC&Q Specialist to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

Responsibilities

Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.

Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.

Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all specifications are met.

Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.

Experience with C&Q parts washer and autoclave is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.

• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Supervise contractors during critical testing of systems and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 8+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6 years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is an asset.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

**Why Mayo Clinic**
Mayo Clinic is top-ranked in more specialties than any other care provider according to U.S. News & World Report. As we work together to put the needs of the patient first, we are also dedicated to our employees, investing in competitive compensation and comprehensive benefit plans ( - to take care of you and your family, now and in the future. And with continuing education and advancement opportunities at every turn, you can build a long, successful career with Mayo Clinic.
**Benefits Highlights**
+ Medical: Multiple plan options.
+ Dental: Delta Dental or reimbursement account for flexible coverage.
+ Vision: Affordable plan with national network.
+ Pre-Tax Savings: HSA and FSAs for eligible expenses.
+ Retirement: Competitive retirement package to secure your future.
**Responsibilities**
Works with the Technical Specialist Coordinator and the lab management team to provide direction for the technical operation of the laboratory. Validates and documents operational changes using divisional processes. Provides direction for operational workflow and serves as an expert resource for the work unit. Responsibilities also include addressing customers concerns, developing and implementing processes and services according to the Mayo Quality System Essentials. Completes other projects or assignments as assigned.
The BPU is a non-testing DLMP laboratory which specializes in the handling, shipping, storage, and preparation for administration of externally manufactured cellular therapies. The TS II role will be one of the primary roles in charge of evaluating the lab's ability to implement new externally manufactured therapies as well as determining the logistics and internal processes the lab will utilize to work with these products. A large amount of the work performed will be working with stake holders outside of the work unit to ensure a seamless process is created while bringing these therapies into the clinic. Additionally, the TS II role is a primary component in the development and maintenance of the work units' internal procedures and batch records that are created based on review and understanding of external sponsor manuals specific to each new cellular therapy.
***Individuals hired to this position are required to complete 2 years in this position before becoming eligible to transfer to other positions within Mayo Clinic***
***This position is not eligible for visa sponsorship with the exception of the TN visa classification; Also, Mayo Clinic DOES NOT participate in the F-1 STEM OPT extension program***
**Qualifications**
Bachelor's degree in clinical/medical laboratory science (CLS/MLS), medical technology (MT), chemistry, biological science from an accredited institution or bachelor's degree from an accredited institution in addition to a certificate in MLS. In histopathology or non-testing laboratories, bachelor's degree with laboratory certification if applicable. Four years of relevant laboratory experience; or a master's degree from an accredited institution in chemical, physical, biological, clinical laboratory science or medical technology and two years of relevant laboratory experience. A HEW certificate may be substituted for the specified degree. Experience with operation and troubleshooting of laboratory instruments and assays. Capable of performing under time constraints, multi-tasking, and working in a fast-paced and changing environment. Demonstrates self-motivation, attention to detail and excellent verbal and written communication skills. Able to work independently. ASCP or other certification pertinent to the laboratory field may be required depending on the laboratory specialty and prevailing regulatory requirements.
ALL MUST be included for your application to be considered:
- CV/Resume
- Cover Letter
- Transcripts (unofficial copy accepted)
- Internal candidates must provide their past performance appraisals
For international/foreign trained applicants, it is the responsibility of the applicant to provide Mayo Clinic the following transcript information in your application:
- MUST have a DETAILED equivalency evaluation
The applicant is responsible for the cost associated with obtaining the equivalency evaluation.
- MUST show US equivalent degree
- Evaluation MUST be completed from an organization listed as a member of the National Association of Credential Evaluation Services (NACES) OR the Association of International Credential Evaluators, Inc. (AICE) Status**
Exempt
**Compensation Detail**
$76,731.20 - $115,003.20 / year. Education, experience and tenure may be considered along with internal equity when job offers are extended.
**Benefits Eligible**
Yes
**Schedule**
Full Time
**Hours/Pay Period**
80
**Schedule Details**
Monday - Friday; 7:30am - 4:00pm. Some flexible scheduling options available. 1-day remote work per week
**Weekend Schedule**
No weekends and no holidays
**International Assignment**
No
**Site Description**
Just as our reputation has spread beyond our Minnesota roots, so have our locations. Today, our employees are located at our three major campuses in Phoenix/Scottsdale, Arizona, Jacksonville, Florida, Rochester, Minnesota, and at Mayo Clinic Health System campuses throughout Midwestern communities, and at our international locations. Each Mayo Clinic location is a special place where our employees thrive in both their work and personal lives. Learn more about what each unique Mayo Clinic campus has to offer, and where your best fit is. ( Opportunity**
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, protected veteran status or disability status. Learn more about the "EOE is the Law" ( . Mayo Clinic participates in E-Verify ( and may provide the Social Security Administration and, if necessary, the Department of Homeland Security with information from each new employee's Form I-9 to confirm work authorization.
**Recruiter**
Jenny Lane
**Equal opportunity**
As an Affirmative Action and Equal Opportunity Employer Mayo Clinic is committed to creating an inclusive environment that values the diversity of its employees and does not discriminate against any employee or candidate. Women, minorities, veterans, people from the LGBTQ communities and people with disabilities are strongly encouraged to apply to join our teams. Reasonable accommodations to access job openings or to apply for a job are available.

Job Description

Job Description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the clients facilities.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in the design, commissioning & qualification, start-up and project management of various processes, systems and facilities. The work will require working out of clients facilities in North Carolina.

Responsibilities

• Provide technical guidance into the assessments, design, project management, commissioning and start-up of equipment and facilities, for upgrades, renovations and expansions of client facilities and processes.
• Lead or support project execution from feasibility through to project completion/handover, including all project stages such as:

Feasibility Assessments

Concept Design, Basic Design, Detailed Design

Procurement

Construction / Installation

Project Controls - Monitoring

Commissioning & Qualification

• Prepare business cases, with project purpose, risks, budget, schedule, resource requirements.
• Manage other design firms, equipment vendors, construction firms and internal / external stakeholders as required to execute projects.
• Manage Capital Projects
• Review technical documentation such as P&IDs, specifications, layouts, manuals, datasheets.
• Integrate safety into the design and execution of all projects (HAZOP reviews, PHSRs, design reviews with EHS representatives).
• Prepare/review automation sequences, as required for Process Automation.
• Engage and coordinate with other other cross-functional departments (Process, automation, building / facilities, procurement, construction management, commissioning, qualification & validation, manufacturing operations, EHS, quality & compliance).
• Facilitate project management tools throughout the execution of projects, such as procurement tracking, vendor management, meeting minutes / action lists, risk register log, schedule updates, project updates.
• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Travel may be occasionally required for meetings with equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation, construction, commissioning, qualification & validation phases.
• You may be involved with other aspects such as client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites, wear necessary safety PPE.
• Supervise contractors during critical installations of process equipment and associated utilities.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.
• As this position requires working on client sites, you will need to comply with the clients safety rules including mandatory vaccination policies for COVID-19, where applicable.

Qualifications

• 10+ years of experience in the biotech industry in project management of various equipment and facilities within the pharmaceutical/biotech industry, with knowledge of requirements for a cGMP operation.
• Previous PM capital projects experience is required.
• Previous Greenfield projects experience is required.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Basic knowledge of AutoCAD.
• Degree, preferably in Mechanical, Chemical, Electrical or other industry related discipline.
• Certification in Project Management would be an asset.
• Travel may be required on occasion. Ability to travel to the US would be an asset.

Salary range: 90,000$ -120,000$ based on experience.

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

Job Description

Job Description

Salary:

Previous Pharmaceutical/Biotech experience is mandatory for this role.

MMR Consulting is a consulting firm specializing in the pharmaceutical and biotechnology industries. Our services include Project Management, Process, Automation, Facilities and Equipment CQV. Pharmaceutical expertise includes Oral Solid Dosage, Semi-Solids, Liquid-Dosage (TS and Aseptic), API manufacturing, Biotechnology (Vaccines, Blood Plasma Fractions, Monoclonal Antibodies).

MMR Consulting has offices in Canada, USA, and Australia.

This is an outstanding opportunity to join our growing team, where the successful candidate will work with a group of specialists involved in project management, commissioning and qualification, of equipment, systems and facilities. The work will require working out of the clients facilities.

This role is for Bioprocess SR. C&Q Specialist role to work on the commissioning, qualification, startup of upstream and downstream bioprocess systems/equipment in the biopharmaceutical industry, as well as process equipment in pharma/biotech industries. The ideal candidate should possess leadership skills to lead/mentor intermediate/junior specialists.

We are looking for candidates for our clients inRaleigh-Durham-Chapel Hill Area and Boulder, Colorado.

Responsibilities

• Provide technical guidance into the commissioning, qualification and start-up of various equipment and facilities.
• Lead the development of key qualification deliverables during the project lifecycle to ensure project is well defined, and the action plan to test the system is applicable and relevant.
• Lead qualification processes throughout the project lifecycle such as VPP, Risk Assessments, RTM, FCCA/dRA, DQ, FAT, SAT, IQ, OQ and PQ as appropriate to ensure timely completion and to ensure all quality and other specifications are met.
• Prepare protocols, execute protocols, summarize data, resolve deviations, prepare final reports.
• Experience with C&Q of upstream or downstream bioprocess systems is required. Experience with C&Q of other process equipment, utilities, facilities is an asset. Thermal Validation experience is an asset.

• Coordinate meetings with cross-functional departments, to drive project progress, facilitate decisions, provide updates.
• Engage other departments, as required, for design reviews and decisions.
• Travel may be occasionally required for meetings with clients, equipment fabrication vendors or Factory Acceptance Testing (FATs).
• Work may require occasional support over shutdowns or extended hours, specifically during installation and commissioning / validation phases.
• Client-management (maintain key Client relationships in support of business development and pursuit of new work), project scheduling/budgeting, coordination of client and MMR resources for effective project delivery, supporting business development (providing technical support to the sales as required for proposals/opportunities), presenting at industry conferences/publishing papers etc.
• Visit construction and installation sites following all site safety requirements.
• Supervise contractors during critical testing of systems and equipment.
• Other duties as assigned by client, and/or MMR, based on workload and project requirements.

Qualifications

• Excellent written and spoken English is required including the preparation of technical documents in English
• Years of experience: 12+ years for years of experience in commissioning, qualification or validation of various systems within the pharmaceutical/biotech industry, where minimum 6+ years should include direct C&Q experience with upstream or downstream bioprocess equipment/systems.
• Knowledge of requirements for a cGMP operations, including SOPs, Change Controls, Validation.
• Experience with developing and executing validation projects. Risk-Based Commissioning & Qualification approaches, such as ASTM E-2500 or ISPE ICQ, is considered an asset.
• Experience with commissioning and qualification of biotech process equipment (upstream or downstream or both), such as some, but not all, of the following: fermentation, bioreactors, downstream purification processes (chromatography, TFF, UF) is considered an asset.
• Experience with commissioning & qualification of process control systems (i.e. PCS, SCADA, Historians) and building automation systems (i.e. Siemens Insight / Desigo, JCI Metasys) are considered an asset.
• Experience with Qualification or Validation of clean utilities, ISO clean rooms, and Thermal Validation is considered an asset.
• Experience with preparation and execution of URSs, DQs, RTMs, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs, NCRs, Final Reports.
• Lead teams of Validation staff, manage staff priorities, provide mentorship/oversight, help staff resolve issues.
• Possess leadership skills, and be able to take initiative to lead projects, involving multiple stakeholders, departments, and varying complexity.
• Possess mentorship skills, to coach and develop junior and intermediate employees.
• Degree, preferably in Mechanical, Electrical, Chemical, Biochemical, Electromechanical, Science or a related discipline.
• Ability to handle multiple projects and work in a fast-paced environment.
• Strong multi-tasking skills

Equal Employment Opportunity and Reasonable Accommodations

MMR Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. Our hiring decisions are based on merit, qualifications, and business needs. We are committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please let us know the nature of your request.

BioPharmaceutical Account Manager - Dallas East, TX
Requisition ID: 6617
Location:
Longview, TX, US
**Territory: Dallas East, TX - Neurology**
Target area for territory is Longview - will consider candidates who live within 40 miles of territory boundaries with access to a major airport. Territory boundaries include: Athens, Longview, Richardson and Rockwall.
**SUMMARY:**
Are you a results-driven biopharmaceutical sales professional looking to be part of an organization that values being curious, adaptable and accountable? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. It's a very exciting time to join our team as we lead the way in creating positive customer experiences!
As a BioPharmaceuticals Account Manager, you lead the promotion of our infusion product, driving demand creation by providing comprehensive clinical knowledge, executing sales and marketing strategies in the local market and partnering to deploy approved services necessary to meet the needs of each account/customer. Our Account Managers are adept at executing against the toughest commercialization challenges in today's rapidly changing environment and must demonstrate strong capability in the following areas:
**ESSENTIAL FUNCTIONS:**
**Business Planning & Account Leadership** - Ability to use digital tools and apply customer and data-based insights to build opportunities, develop strategy & tactics and prioritize resources to enhance territory effectiveness in competitive markets.
**Selling** - Deliver messages in a clear and compelling way to customers, effectively probe customer needs to handle objections, and close every call with a commitment to action to drive changes in behavior. Engage with multi-disciplinary customers using a total office call approach to communicate value proposition of a new delivery method.
**Customer Development** - Entrepreneurial mindset to gain access, build and maintain productive internal and external relationships through effective communication and collaboration based on customer needs and organizational goals.
**Payer Access** - Ability to grasp sophisticated reimbursement and distribution processes in a complex coverage landscape. Anticipates and communicates impact on product portfolio to key internal and external partners and effectively addresses payer access issues (Medicare, Medicaid, Commercial) using Lundbeck resources.
**Local Market & Therapeutic Area Expertise** - Gather and validate key trends and dynamics in the market, map account linkages, and apply comprehensive therapeutic knowledge to uncover and prioritize unique opportunities. Demonstrates a clear and detailed understanding of the disease state and its impact on customers and patients including the full range of treatment options available.
**Pharmaceutical Environment/Compliance** - Ability to apply knowledge of pharmaceutical and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. Ability to apply knowledge of overall healthcare economy and industry practices. Accountability and adherence to corporate, FDA, and PDMA guidelines.
**REQUIRED EDUCATION, EXPERIENCE and SKILLS:**
+ Bachelor of Arts or Bachelor of Sciences degree from an accredited college or university
+ 5+ years of Specialty Sales experience in Pharmaceutical, Biopharmaceutical, Biologics or Medical Device sales experience
+ Ownership and accountability for the development and execution of a fully integrated account plans
+ Self-starter, with a strong work ethic and outstanding communication skills
+ Proven track record of consistent sales performance
+ Must demonstrate the intellectual capacity to score highly on disease and product training exams, including being certified on product knowledge annually
+ Must be computer literate with proficiency in Microsoft Office Software
+ Must live within 40 miles of territory boundaries
+ Driving is an essential duty of this job; must have a valid driver's license with a safe driving record that meets company requirements
+ Meeting and complying with reasonable industry-standard credentialing requirements of healthcare providers / customer facilities is required for continued employment with Lundbeck.
**PREFERRED EDUCATION, EXPERIENCE AND SKILLS:**
+ Infusion/rare disease sales experience in both the Outpatient Infusion setting and Specialty Pharmacy channel with a strong understanding of pricing and reimbursement.
+ Neurology experience specific to migraine
+ Experience in both the medical or specialty pharmacy benefit market
+ Experience working with high influence customers in physician clinics, integrated health systems, infusion centers and alternative sites of care
+ Product launch or expansion experience, particularly in a new therapeutic class
+ Strong analytical background, and experience using sales data reporting tools to identify trends
+ Strong leadership through participation in committees, job rotations, panels and related activities
**TRAVEL:**
+ Willingness/Ability to travel up to 30% - 40% domestically to (a) regularly meet/interact with customer base and internal personnel within assigned territory; and (b) typically attend 4-8 internal/external conferences and meetings spanning locations within the United States. Travel must be able to be completed in a timely manner.
The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate's geographical location, qualifications, skills, competencies, and proficiency for the role. Salary Pay Range: $150,000 - $65,000 and eligibility for a sales incentive target of 41,500. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, company match 401k and company car. Additional benefits information can be found on ourcareer site ( . Applications accepted on an ongoing basis.
**Why Lundbeck**
Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on theU.S. career site ( .
_Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit theU.S. career site ( ._
_Lundbeck is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates inE-Verify ( ._
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.
**About Lundbeck**
At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.
Through cutting edge science and strong partnerships, we develop and market some of the world's leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.
The brain health challenge is real. Our commitment is real. Our impact is real.

Our client, a pioneering pharmaceutical company, is seeking a highly motivated Senior Pharmaceutical Scientist to join their R&D team in Seattle, Washington, US . This role is instrumental in advancing novel drug candidates through the development pipeline. The ideal candidate will possess extensive experience in drug formulation, pre-clinical development, and a deep understanding of regulatory requirements within the pharmaceutical industry.

Key Responsibilities:

• Lead the formulation development of small molecule and/or biologic drug products, including pre-formulation studies, excipient compatibility, and stability testing.
• Design and execute pre-clinical studies to assess drug safety, efficacy, and pharmacokinetics.
• Develop and validate analytical methods for characterization and quality control of drug substances and products.
• Prepare regulatory submission documents (e.g., IND, NDA) and interact with regulatory agencies.
• Collaborate with internal teams (e.g., chemistry, biology, clinical) and external partners to advance drug candidates.
• Troubleshoot formulation and analytical challenges encountered during development.
• Stay current with scientific literature, industry trends, and regulatory guidelines.
• Contribute to the strategic planning and decision-making for drug development projects.
• Mentor junior scientists and contribute to a collaborative and innovative research environment.
• Manage external vendor relationships for specialized development activities.

Qualifications:

• Ph.D. in Pharmaceutical Sciences, Chemistry, Pharmacology, or a related field.
• Minimum of 7 years of experience in pharmaceutical R&D, with a focus on drug formulation and pre-clinical development.
• Proven track record of successfully developing drug candidates from early-stage to IND filing.
• Extensive knowledge of GMP principles, analytical techniques (HPLC, GC, MS, etc.), and regulatory guidelines (FDA, EMA).
• Experience with various dosage forms (e.g., oral solids, injectables, topical).
• Strong scientific understanding of drug delivery systems and formulation strategies.
• Excellent written and verbal communication skills, with the ability to present complex scientific data effectively.
• Demonstrated ability to work independently and lead projects in a team-oriented environment.
• Proficiency in data analysis and interpretation.
• Experience with biologics formulation is a significant advantage.

This hybrid position offers a competitive salary and benefits package, along with the opportunity to contribute to life-changing therapies in Seattle, Washington, US .

_This position is on-site in Tarrytown, NY 4 days a week and 1 day from home. A fully remote role is not possible for this position._
Using extensive program management knowledge and experience in the drug development industry, the **Director, Development Program Management** provides operational leadership, direction and support to a team, program or project of moderate to large scope, (within a given Therapeutic Area) as well as to the DPM department as a whole. The Director, Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated (project) program plans, goals, budgets, and timelines. Director, Development Program Management is responsible for the successful operation of activities of major significance to the organization.
**In a typical day you will:**
+ Provide operational leadership, direction and support of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial.
+ Independently lead multiple or complex development programs.
+ Partner with the Strategic Program Lead to provide operational leadership of program(s) and supports development and execution of overall program strategy by facilitating cross-functional Strategic Development Team. Independently assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Strengthens and leads high performance teams.
+ Leverage significant project management experience and knowledge of the drug development process, drives team alignment in creation of integrated project / program plans, timelines and budgets. Ensures efficient delivery of plans. Directs annual program goal setting in alignment with Regeneron's overall goals and monitors progress against these goals. Champions potential program risks and ensures contingency plans are in place.
+ Act as a key liaison between Regeneron and our strategic alliance partners and collaborators (where applicable). Prepares, provides input, and / or manages the process involving major presentations for collaboration meetings effecting key business decisions. Responsible for facilitating and driving decision making in support of the joint strategic objectives of the program.
+ **Communication:** Ensures effective, accurate, and timely scientific / technical program-related communication to the team and Sr. Management. Adept at tailoring communications based on audience, effectively framing and communicating nuanced context for stakeholders and capturing rationale for decisions.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company in order to establish credibility with professionals on the project teams.
+ Understand and motivate others and build effective teams.
+ Have strong presentation and critical thinking skills.
+ Actively promote constructive interactions among team members in order to address difficult situations.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Handle multiple projects and priorities with exceptional organizational and time management skills (both project and self)
+ Thrive in fast paced organizations; expert in dealing with ambiguity and uncertainty
**In order to be considered qualified** , you must have a Bachelor's degree and 12+ years of in-house pharmaceutical program management with knowledge of the drug development process as well as understanding of clinical trials.
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)**
$180,400.00 - $300,700.00

This position is on-site 4 days per week and 1 day from home. A remote position is not possible for this role.
**The Manager Development Program Management** provides operational direction as the leader for one or more development programs. Manager Development Program Management executes the strategic direction of a program from preclinical through commercialization by driving the development and implementation of integrated program plans, goals, budgets, and timelines. The Manager Development Program Management is responsible for forming and managing effective cross functional teams and leads a network of functional area project managers.
**In a typical day you will:**
+ Support development of a program throughout its lifecycle, by integrating key stakeholders from Discovery, Manufacturing, Preclinical, Global Development and Commercial. Independently manages multiple development programs, often working under consultative direction.
+ Partner with the Strategic Program Lead to provide operational leadership of program (s) and supports development and execution of overall program strategy by facilitating cross functional Strategic Development Team. Assesses and proactively addresses the needs of the program from pre-IND through commercialization and makes operational decisions to support requirements for success. Actively aims to strengthen and lead high performance teams.
+ Lead annual goal setting sessions to develop project / program level goals that align with Regeneron's overall goals and monitors progress against these goals.
+ Develop contingency and risk mitigation plans. Oversees the development of integrated project / program plans and actively monitors progress against the approved baselines. Responsible for oversight of the integrated program timeline and budget, including management of variances and escalation where appropriate.
+ Manage the project / program interactions and deliverables between Regeneron and our strategic alliance partners and collaborators (where applicable). Fosters collaborative relationships across the alliance program teams to develop and execute strategic development plans.
**This role may be for you if you:**
+ Have excellent written, verbal and interpersonal communication skills
+ Can motivate others and build effective teams.
+ Possess strong critical thinking skills.
+ Can make connections and relate details to broader program strategy and goals.
+ Resolve and negotiate conflicts or problems with tact, diplomacy and composure.
+ Are highly organized, and have solid time management skills (both project and self), with ability to manage multiple priorities.
**In order to be considered for this opportunity** , you must have a BS or MS degree with at least 7+ years of relevant broad project/program management experience required, preferably in the pharmaceutical or related industry and drug development. Specific experience managing the development strategy for a drug candidate is necessary.
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)**
$113,100.00 - $184,700.00