Principal Scientist, Large Molecule Analytical

MSD Malaysia; Rahway (NJ); On-site; USD 157,000 - 247,000; Full time

Benefits offered by this job

Annual bonus

Long-term incentive

Comprehensive benefits

Job summary

MSD Malaysia seeks a Principal Scientist to lead the Biologics Analytical Research & Development team at Rahway, NJ. You will define analytical strategy, mentor a team of scientists, and collaborate across biology, chemistry, and lab informatics to enable biologics APIs.

You will drive development, qualification, and transfer of analytical methods for release, characterization, and stability testing, while communicating findings through reports and regulatory submissions.

Qualifications

• Ph.D./M.S./B.S. with pharmaceutical industry experience. 8–14+ years depending on degree.
• Extensive experience with biologics analysis and residual assay development.
• Strong leadership and mentoring capabilities; matrix management experience.
• Experience delivering scientific strategy and cross-functional collaboration.

Responsibilities

• Define analytical strategy and lead a team to solve complex problems at biology-chemistry interface.
• Develop and qualify release, characterization, and stability assays for clinical material.
• Mentor scientists and collaborate across functions to transfer assays.
• Author technical reports and contribute to regulatory filings as needed.

Skills

Analytical Method Development

Assay Development

Bioanalytical Analysis

Chromatographic Techniques

Clinical Judgment

Cross-Functional Teamwork

Stability Testing

Technical Writing

Mentoring Staff

Matrix Management

Education

Ph.D. in analytical chemistry/biochemistry

M.S. in analytical chemistry/biochemistry

B.S. in analytical chemistry/biochemistry

Job description

Job Description The Biologics Analytical Research & Development department of our Company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a highly visible and impactful senior scientific role tasked with working closely with the group Director to define analytical strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs). We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected.

Qualifications

• 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
• B.S. in analytical chemistry/biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry

Required Experience and Skills

• 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 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 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.

Required Skills

• Analytical Method Development
• Assay Development
• Bioanalytical Analysis
• Chromatographic Techniques
• Clinical Judgment
• Cross-Functional Teamwork
• Dosage Forms
• Ethical Compliance
• Liquid Chromatography (LC)
• Matrix Management
• Mentoring Staff
• Method Validation
• Personal Initiative
• Stability Testing
• Technical Writing

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.

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.

The salary range for this role is $156,900.00 - $247,000.00 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.

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: 09/30/2026

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.