Associate Principal Scientist, Biologics Analytical Research & Development

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

Benefits offered by this job

401(k) plan

Healthcare benefits

Job summary

MSD in Rahway, New Jersey is seeking an Associate Principal Scientist to solve complex analytical problems at the interface of biology, chemistry, and lab informatics to enable biologics development. This is a laboratory-based, team-oriented role in a fast-paced environment.

The successful candidate will develop, qualify and transfer assays for monoclonal proteins, lead cross-functional projects, and contribute to scientific publications and regulatory documents.

Qualifications

• BS in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 12 years of relevant experience; or MS with 8 years; or PhD with 4 years.
• Strong background in separations science and extensive experience with UPLC/HPLC analysis of biologics (SEC, RP, IEX).
• Experience with develop/qualify/transfer of release, characterization, stability assays; data analysis and statistics.

Responsibilities

• Develop, qualify, implement, troubleshoot and transfer analytical methods for monoclonal proteins or complex therapeutics.
• Lead assay platform development and benchmarking against industry standards; provide technical leadership for DOE/QbD and data interpretation.
• Author internal reports and sections of regulatory filings; mentor and coach team members; communicate effectively across functions.

Job description

Job Description

The Biologics Analytical Research & Development department of our Research & Development Division is seeking applicants for an Associate Principal Scientist position available at its Rahway, New Jersey research facility. The Associate Principal Scientist is a laboratory-based scientific role tasked with solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of Biologics drug substances and drug products. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.

Responsibilities

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 have effective organizational, multi-tasking, oral/written communications skills, show 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: B.S. in Chemistry, Biochemistry, Engineering, Pharmaceuticals, or related field with 12 years of relevant experience; or Master's degree with 8 years of relevant experience; or Ph.D. with 4 years of relevant experience.

Required Experience and Skills: Strong background and experience in separations science Extensive experience with UPLC/HPLC analysis of biologics (e.g. SEC, RP, IEX) Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques 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. Experience with matrix management and peer to peer coaching Accurately and efficiently documentation of experiments Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills

Understanding of protein degradation mechanisms and link between analytical 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<1033>. Experience in representing analytical functional area on project teams. 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).

Preferred Skills

#AR&D Required Skills: Adaptability, Analytical Method Development, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cross-Functional Teamwork, External Collaboration, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Optimism, Process Analytical Technology (PAT), Protein Analysis, Teamwork

Equal Employment Opportunity

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. 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: EEOC Know Your Rights EEOC GINA Supplement 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. Learn more about your rights, including under California, Colorado and other US State Acts

Location

The primary location for this posting is: USA - New Jersey - Rahway

Salary Range

Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $142,400.00 - $224,100.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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.

Benefits

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.

Additional Locations

Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

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

Employee Status & Relocation

Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a

Job Posting End Date

Job Posting End Date: 10/16/2026 *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.

Company Summary

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.