Merck · 23 hours ago
Principal Scientist, Biologics Analytical R&D
USA - New Jersey - Rahway
Full-time
Onsite
Senior Level, Lead/Staff
$157K/yr - $247K/yr
8+ years expMerck is a leading pharmaceutical company seeking a Principal Scientist for its Biologics Analytical Research & Development department located in Rahway, New Jersey. The role involves defining analytical strategies and leading a team of scientists to solve complex analytical problems related to biologics active pharmaceutical ingredients (APIs). The ideal candidate will possess strong leadership skills and a proven track record in scientific excellence.
BiotechnologyHealth CareMedicalPharmaceutical
Responsibilities
Define analytical strategy and lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines
Develop talent through good mentoring skills and experience with matrix management and peer to peer coaching
Deliver complex objectives under aggressive timelines in a rapidly changing environment
Design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development
Author and review internal technical reports, sections of regulatory filings and external scientific publications
Qualification
Required
Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry
Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques
Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques
Strong background in analytical control strategy development and execution
Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer to peer coaching
Demonstrated ability for taking initiative, creativity, and innovation in problem solving
Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development
A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines
Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications
Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment
Preferred
Understanding of protein degradation mechanisms and link between analytical methodologies for analysis
Experience with qualification, validation, and transfer of assays to a GxP or regulated laboratory environment as listed in ICH Q2 and USP<1033>
Experience with complex glycan analysis and link to mechanisms of actions
Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein)
Knowledge and experience in Antibody Drug Conjugate method development
Established scientific reputation supported by publications and external presentations
Strong external network to benchmark competitors and equipment vendors
Experience in high-throughput experimentation and data-rich experimentation
Benefits
Medical
Dental
Vision healthcare
Other insurance benefits (for employee and family)
Retirement benefits, including 401(k)
Paid holidays
Vacation
Compassionate and sick days
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
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2026-01-22
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