Associate Principal Scientist, Biologics Analytical R&D

Merck; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Rahway, NJ, seeks an Associate Principal Scientist for the BAR&D group to tackle complex analytical challenges in biologics drug product development. This laboratory-based role leads method development, qualification, transfer and troubleshooting for monoclonal proteins and other complex biologics, while collaborating across functions and mentoring junior staff.

The candidate will design experiments, interpret data, author reports and contribute to regulatory filings, with emphasis

Qualifications

• Bachelor's degree with 10+ years, MS with 7+ years, or PhD with 3+ years in relevant field.
• Hands-on separation sciences with chromatography or CE for biologics.
• Experience with residual impurity assays using immunoassay techniques.
• Ability to co-design, draft, execute/direct work related to method bridging and reports.
• Excellent communication and cross-functional collaboration.
• Matrix management and peer coaching experience.

Responsibilities

• Develop, qualify, implement, troubleshoot and transfer analytical methods for monoclonal proteins or complex biologics.
• Develop new assay platforms and benchmark against industry standards.
• Provide technical leadership for experimental design and data interpretation.
• Author SOPs, technical reports, and regulatory submissions sections (IND, BLA).
• Collaborate cross-functionally and mentor junior staff.

Skills

Analytical R&D

Biochemistry

Biologics assay development

Chromatography

Cell-based assays

Teamwork

Education

B.S./MS/PhD in related field

Tools

SEC/RP/IEX/HILIC

CE analysis (CE-SDS, iCIEF)

ELISA/qPCR

JMP/MiniTab

Regulatory filings (IND/BLA)

Job description

Job Description

The Biologics Analytical Research & Development department (BAR&D) is seeking an Associate Principal Scientist position at the Rahway, New Jersey site. This role is a laboratory-based scientific role tasked with solving complex analytical challenges, to enable development of Biologics drug products. The successful candidate must function well in a collaborative, fast-paced, multidisciplinary team environment. The qualified candidate will be responsible for development, qualification, implementation, troubleshooting and transfer of analytical methods for monoclonal proteins or other complex therapeutic proteins. Responsibilities include development of new assay platforms, benchmarking current approaches/techniques to industry standards, and providing technical leadership of design of experiments and data interpretation. Applicants must be highly organized, possess excellent oral/written communications skills, display scientific leadership, and a desire to conduct research and publish. Experience leading small groups of technical personnel and analytical projects will aid in distinguishing candidates. Evidence of strong cross‑functional collaboration in an academic or industrial setting is also preferred.

Qualifications

Education

• Chemistry, Biochemistry, Engineering, Pharmaceutical Sciences, or related field, B.S. with 10+ yrs, MS with 7+ yrs, or Ph.D. with 3+ yrs of relevant experience.

Required Experience And Skills

• Hands‑on experience in separation sciences with chromatography, (e.g. SEC, RP, IEX, HILIC) and/or experience with capillary electrophoresis (CE) analysis (e.g. CE‑SDS, iCIEF) for biologics.
• Experience with residual impurity assay development using molecular biology and immunoassay techniques (ELISA, qPCR, etc.).
• Ability to co‑design, draft, execute/direct work related to method bridging, comparability, the setting of specifications, etc., from protocol to final report.
• Ability to design, execute and/or direct the development of release/stability and characterization methods for clinical trial material and in support of product/process development per ICH Q2 (R2) guidance through method qualification.
• Excellent oral and written communication skills; ability to work both independently and cross‑functionally.
• Authoring and reviewing of SOPs, technical reports, publications and appropriate sections of regulatory filings (e.g., IND, BLA).
• Experience with matrix management and peer to peer coaching.

Preferred Experience And Skills

• Design of Experiment principles including statistical data analysis using JMP, MiniTab, FusionAE, etc.
• Broad knowledge on the panel of biologics assays, charge & size variants, glycans, purity/impurity.
• Understanding of protein degradation mechanisms and the link between analytical/orthogonal methodologies for analysis.
• Experience with qualification, validation, and transfer of assays to a GLP or regulated laboratory environment as listed in ICH Q2 and USP.
• Experience in representing analytical functional area on project teams.
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody‑drug conjugate, fusion protein)
• Experience in data analytics.

Required Skills

• Analytical Research and Development (R&D)
• Biochemistry
• Biological Assay Development
• Cell‑Based Assays
• Chromatographic Techniques
• Enzyme Linked Immunosorbent Assay (ELISA)
• High‑Performance Liquid Chromatography (HPLC)
• High Resolution Mass Spectrometry (HRMS)
• Immunoassays
• Ion Exchange
• Liquid Chromatography (LC)
• Liquid Chromatography‑Mass Spectrometry (LC‑MS)
• Mass Spectrometry Analysis
• Pharmaceutical Sciences
• Real Time Polymerase Chain Reaction (qPCR)
• Separation Sciences
• Teamwork

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.

Requirements

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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Salary

The salary range for this role is

$142,400.00 - $224,100.00

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.

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

No Travel Required

Flexible Work Arrangements

Not Applicable

Shift

1st - Day

Valid Driving License

No

Hazardous Material(s)

n/a

Job Posting End Date

10/13/2026

• 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.

Requisition ID

R404891