Merck
Principal Scientist, Biological Characterization Analytical R&D
Merck, Rahway, New Jersey, us, 07065
Overview
The Analytical Research & Development department of our Company Research Laboratories Division seeks a Principal Scientist at its Rahway, New Jersey research facility. This role requires a collaborative, self‑motivated leader with deep expertise in biological characterization and structure/function assessment of biologic modalities, including mAbs, ADCs, fusion proteins, immunomodulatory molecules, immune‑cell engagers, and complex peptide/protein modalities. The scientist will work closely with cross‑functional teams—Discovery, Pre‑clinical, Early Development, Analytical, Formulation, and Commercial Manufacturing—to drive problem‑solving and innovation throughout the biologics pipeline.
Responsibilities
Shape and execute strategy for biological characterization in clinical development and commercialization.
Develop and implement robust non‑GMP characterization methods using quality by design principles and comprehensive life‑cycle management.
Mentor and supervise junior colleagues, fostering a culture of scientific excellence and talent development.
Anticipate partner needs, leveraging strategic thinking and effective networking to solve complex scientific challenges.
Lead continuous improvement of team productivity through organizational skill enhancement, resource planning, and process standardization.
Collaborate on pipeline progression, strategic initiatives, and capability gap assessment to expand the toolbox for new biologics modalities.
Champion compliance, safety, and a culture of diversity, equity, and inclusion.
Keep up‑to‑date with scientific, industry, and regulatory developments and actively publish and present in the scientific community.
Minimum Education Requirements
Ph.D. with 8+ years of experience, MS with 10+ years, or BS with 14+ years in Cell Biology, Molecular Biology, Immunology, Pharmacology, Translational Science, Biotechnology, or a related field.
Required Experience, Skills, and Competencies
Leadership and mentorship of cross‑functional teams.
Expertise in designing and developing biologic characterization assays for therapeutic proteins and cell/gene therapy products.
In-depth understanding of mechanistic structure‑function and its impact on biological activity.
Ability to interpret characterization data in the context of product development and analytical control strategy.
Strong problem‑solving skills, prioritization under tight timelines, and adaptation to dynamic environments.
Established scientific reputation with publications, patents, and presentations at scientific meetings.
Experience in regulatory guidance, quality standards, and submission preparation (IND, BLA).
In‑vitro immunogenicity assessment and risk assessment for novel biologics.
Cell line engineering, gene editing (CRISPR), and pharmacokinetics assay development.
Proficiency in flow cytometry, confocal microscopy, and high‑content imaging.
Preferred Experience & Skills
Authoring regulatory guidance and quality standards.
In‑vitro characterization assays for pharmacokinetic assessment.
Experience with gene engineering and CRISPR technologies.
Salary & Benefits Salary range: $153,800.00 – $242,200.00 (based on experience and qualifications). Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, 401(k) with company match, paid holidays, vacation, and compassionate leave.
Application Please submit your application through the provided portal. The application deadline is specified in the posting. For employees of the company, use the Workday Jobs Hub.
Equal Employment Opportunity We are 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, veteran status, disability status, or any other protected characteristic. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC resources at the required links.
Legal & Compliance Merck & Co., Inc. (Merck Sharp & Dohme LLC) does not accept unsolicited assistance from search firms for employment opportunities. CVs or resumes submitted by search firms without a written agreement will be deemed company property and no fee will be paid to the agency.
Relocation & Visa Recruiting for positions within the U.S. and Puerto Rico. Visa sponsorship may be available for qualifying candidates. Travel requirements will be disclosed during the interview process.
Job Posting End Date 11/17/2025
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Responsibilities
Shape and execute strategy for biological characterization in clinical development and commercialization.
Develop and implement robust non‑GMP characterization methods using quality by design principles and comprehensive life‑cycle management.
Mentor and supervise junior colleagues, fostering a culture of scientific excellence and talent development.
Anticipate partner needs, leveraging strategic thinking and effective networking to solve complex scientific challenges.
Lead continuous improvement of team productivity through organizational skill enhancement, resource planning, and process standardization.
Collaborate on pipeline progression, strategic initiatives, and capability gap assessment to expand the toolbox for new biologics modalities.
Champion compliance, safety, and a culture of diversity, equity, and inclusion.
Keep up‑to‑date with scientific, industry, and regulatory developments and actively publish and present in the scientific community.
Minimum Education Requirements
Ph.D. with 8+ years of experience, MS with 10+ years, or BS with 14+ years in Cell Biology, Molecular Biology, Immunology, Pharmacology, Translational Science, Biotechnology, or a related field.
Required Experience, Skills, and Competencies
Leadership and mentorship of cross‑functional teams.
Expertise in designing and developing biologic characterization assays for therapeutic proteins and cell/gene therapy products.
In-depth understanding of mechanistic structure‑function and its impact on biological activity.
Ability to interpret characterization data in the context of product development and analytical control strategy.
Strong problem‑solving skills, prioritization under tight timelines, and adaptation to dynamic environments.
Established scientific reputation with publications, patents, and presentations at scientific meetings.
Experience in regulatory guidance, quality standards, and submission preparation (IND, BLA).
In‑vitro immunogenicity assessment and risk assessment for novel biologics.
Cell line engineering, gene editing (CRISPR), and pharmacokinetics assay development.
Proficiency in flow cytometry, confocal microscopy, and high‑content imaging.
Preferred Experience & Skills
Authoring regulatory guidance and quality standards.
In‑vitro characterization assays for pharmacokinetic assessment.
Experience with gene engineering and CRISPR technologies.
Salary & Benefits Salary range: $153,800.00 – $242,200.00 (based on experience and qualifications). Eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, 401(k) with company match, paid holidays, vacation, and compassionate leave.
Application Please submit your application through the provided portal. The application deadline is specified in the posting. For employees of the company, use the Workday Jobs Hub.
Equal Employment Opportunity We are 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, veteran status, disability status, or any other protected characteristic. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC resources at the required links.
Legal & Compliance Merck & Co., Inc. (Merck Sharp & Dohme LLC) does not accept unsolicited assistance from search firms for employment opportunities. CVs or resumes submitted by search firms without a written agreement will be deemed company property and no fee will be paid to the agency.
Relocation & Visa Recruiting for positions within the U.S. and Puerto Rico. Visa sponsorship may be available for qualifying candidates. Travel requirements will be disclosed during the interview process.
Job Posting End Date 11/17/2025
#J-18808-Ljbffr