Senior Scientist, Biologics Analytical R&D (On-site)

Job Description

Join a team dedicated to advancing lifesaving and life-enhancing medicines through exceptional scientific oversight of our company's biologics portfolio from development through commercialization. Grounded in ethics, integrity, transparency, and scientific rigor, we bring together diverse perspectives to deliver transformative medicines.

We are seeking a Senior Scientist to join our Biologics Analytical Research & Development (AR&D) GMP Operations team in North Wales, PA, part of the West Point campus footprint. The ideal candidate brings strong technical judgment, GMP discipline, and cross-functional collaboration skills to support biologics development and commercialization.

The successful candidate will apply separation-based analytical methods, including HPLC, UPLC, CE, and iCIEF, to support method optimization, phase-appropriate validation, analytical method transfer, lifecycle management, and GMP testing. The incumbent will collaborate with Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, CMC Regulatory Affairs, and external stakeholders to resolve technical challenges, provide scientifically sound guidance, and drive pipeline progress.

Responsibilities

• Validate, implement, transfer, and maintain analytical methods supporting clinical material testing and commercialization readiness.

• Act as a new project lead by collaborating with external stakeholders and managing validation and testing activities for assigned programs across the team.

• Serve as a subject matter expert across biologics programs, products, and analytical platforms.

• Interpret and review analytical data, assess trends, support investigations, deviations, CAPAs, and data-driven technical decisions.

• Execute and oversee GMP release, stability, and in-process analytical testing for biologics drug substance and drug product using established and advanced analytical technologies.

• Provide scientifically sound recommendations to address technical challenges and support decision-making across development stages.

• Support biologics registrations, product launches, and technical troubleshooting.

• Build and manage project timelines and deliverables to drive milestone completion.

• Support audits, inspections, investigations, and CAPA activities through disciplined documentation and inspection-ready practices.

• Ensure analytical activities are conducted in accordance with cGMP expectations, data integrity principles, and applicable regulatory requirements.

• Support instrument qualification activities, including IQ/OQ/PQ, as needed.

• Contribute to strategic initiatives and cross-functional improvement efforts across matrixed teams.

• Author and review technical documentation, including regulatory submissions.

• Support evolving departmental priorities through flexible scientific and operational contributions.

Qualifications

• Ph.D. in Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field with a minimum of 2 years of relevant experience or

• M.S. with a minimum of 3 years of relevant experience; or

• B.S. with a minimum of 7 years of relevant experience.

Experience and Skills

Required

• Minimum of 2 years of experience working in a GMP or regulated laboratory environment.

• Demonstrated technical expertise with separation-based analytical methods, including HPLC, UPLC, CE, iCIEF, or other advanced technologies.

• Strong organizational and project management skills, with demonstrated ability to manage timelines, deliverables, and proactively communicate risks.

• Demonstrated ability to resolve technical issues using innovative, scientifically sound solutions.

• Ability to work independently and effectively within a fast-paced, multidisciplinary matrix team.

• Excellent oral and written communication skills.

• Strong interpersonal and leadership skills, with the ability to lead through influence in a matrixed environment.

• Self-motivated, accountable, and results-oriented.

• Willingness to occasionally work evenings, weekends, or irregular hours to support business needs.

Preferred

• Experience supporting GMP release, stability, and in-process testing for biologics drug substance or drug product.

• Proficiency with GMP laboratory systems, including LIMS, electronic notebooks, Empower, and/or data analytics platforms.

• Knowledge of cGMP, ALCOA+, and key regulatory expectations, including USP, ICH, and FDA guidance.

• Proficiency with analytical method development, validation, transfer, lifecycle management, and/or regulatory submissions.

• Involvement in biologics late-stage development, commercialization, registration, or product launch activities.

• Strong technical writing skills for scientific, GMP, and/or regulatory documentation.

• Experience with UV spectrophotometric, compendial, or platform analytical methods.

• Applied knowledge of deviation, investigation, CAPA, and change control processes.

• Contributions to continuous improvement or Lean Six Sigma initiatives.

ARD

EligibleforERP

Required Skills:

Adaptability, Analytical Method Development, Analytical Validation, Bioanalytical Analysis, Biochemistry, Change Control Processes, Chromatographic Techniques, Cross-Functional Collaboration, Data Integrity, GMP Compliance, Innovative Thinking, Pharmaceutical Sciences, Project Management, Regulatory Requirements, Strategic Initiative, Strategic Thinking, Technical Writing, Technical Writing Documentation, Ultra Performance Liquid Chromatography (UPLC), Ultraviolet-Visible UV/VIS Spectrophotometers, Working Independently

Preferred Skills:

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US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/12/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.