Principal Scientist (Director), Analytical R&D

Job Description

Our ability to excel relies on the innovation, integrity, expertise and teamwork of our scientists. We value rigorous scientific exploration, cross-functional collaboration, creative-thinking and dedication to building strong and operationally excellent teams. As part of our industry-leading drug development programs, you will have the opportunity to collaborate with highly talented and dedicated colleagues, working urgently to develop lifesaving medicines and vaccines and deliver the next medical breakthroughs.

The Analytical Research & Development department of our Company Research Laboratories Division is seeking an experienced and highly-motivated Principal Scientist with extensive cell-based characterization assay development expertise. The successful candidate will have experience with the design, execution and optimization of a broad range of characterization assays and be responsible for development of analytical control strategies for structure function assessment of biologic modalities (e.g. mAb, antibody-drug conjugates, fusion proteins, immunomodulatory molecules, immune-cell engagers, and complex peptide/protein modalities). The applicant will have the opportunity to engage in cross-functional teams to drive effective problem solving and innovation across the Biologics pipeline in a fast-paced, multidisciplinary environment.

This is a full-time position reporting to the Director in the Analytical Research and Development department and is located at our corporate headquarters and research facilities in Rahway, New Jersey.

Responsibilities include, but are not limited to:

• Work closely with the group Director to define and execute analytical control strategy for biological characterization at all stages of clinical development, as well as for post-approval support.
• Lead experimental design, development and implementation of robust MoA-reflective in vitro cell-based functional assays (i.e. binding, proliferation, cell-signaling, cytotoxicity, cytokine production), using primary cells, luminescence- and fluorescence-based reporter assays, flow cytometry, and cell imaging.
• Serve as scientific supervisor providing technical and scientific expertise to a team of scientists, enabling delivery of pipeline and strategic initiatives. Guide and mentor junior scientists in experimental design, data interpretation and documentation. Inspire, encourage and support employee development, partner with the director to build independent ownership and evolution of specializations within the team.
• In active collaboration with management, contribute to continuous improvement of team productivity via enhancing effective organizational skills, accurate resource planning and prioritization, utilization of best practices and standardization of processes, and evaluation of innovative scientific and technological tools.
• Drive scientific objectives associated with the development of new/improved products or technology- and utilize effective networking to solve complex scientific and technical problems. Lead the development of a toolkit for characterization of novel biologics modalities for deep structure-function understanding.
• Author and review experiment lab notebooks, independently analyze results and effectively communicate results and scientific data to cross-functional teams. Provide data interpretation for structure-function assessments, connecting PTM relationships with deep mechanistic characterization of functional biological activity to inform critical product and process quality attributes.
• Author analytical reports and analytical sections of regulatory filings. Primary author of external publications, presentations, regulatory documents and/or primary inventor of patents.
• Represent the team on internal scientific forums and leading external scientific conferences and actively engage with the external scientific community, industry and regulatory landscape.

Minimum Education Requirements:

• Ph.D. with 8+ years, MS with 10+ years, or BS with 14+ years of experience in Immunology, Cell Biology, Molecular Biology, Biochemistry, Pharmacology, Biotechnology or a related field.

-

Required Experience, Skills, and Competencies:

• Strong technical expertise in the design of biological characterization assays for therapeutic proteins, monoclonal antibodies and antibody-drug conjugates. In-depth understanding and hands-on experience with the development of cell-based functional assays, flow cytometry, molecular biology and mammalian cell-line engineering.
• Demonstrated expertise in comprehensive characterization of molecular function and impact of structural changes on biological activity, CQA assessment, expertise in interpretation of data in context of broader process and product development, critical reagent characterization and overall analytical control strategy.
• Excellent interpersonal, verbal and written communication skills, with the ability to convey complex scientific concepts clearly. Demonstrated initiative, creativity, and innovation in problem solving.
• Demonstrated ability to develop talent, supervise, coach and mentor others.
• Ability to adapt to and prioritize complex objectives under tight timelines in a dynamic cross-functional environment.
• Demonstrated expertise with authoring of regulatory submissions and interactions with health authority agencies.
• Established scientific reputation and external influence, supported by publications, patent authoring, external presentations at scientific meetings, membership in (or leading) cross-company working groups or consortia.

-

Preferred Experience & Skills:

• Previous experience in project management or leading cross-functional teams is a plus
• In vitro immunogenicity assessment, with focus on risk assessment for biologics and novel biologic modalities is a plus.
• Proficiency in statistical analysis and equivalency assessment is a plus
• Previous working experience with pharmacokinetics (PK) assessment and bioanalytical assay development is a plus.
• Proficiency in confocal microscopy and high-content imaging is a plus.

Required Skills:
Analytical Method Development, Assay Development, Bioanalytical Analysis, Chromatographic Techniques, Dosage Forms, Liquid Chromatography (LC), Manufacturing, Mentoring Staff, Method Validation, Stability Testing

Preferred Skills:
Characterization Techniques, Flow Cytometry, Mammalian Cell, Molecular Biology, Scientific Publications

Current Employees apply HERE

Current Contingent Workers apply HERE

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.

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

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

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 .

You can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
Not Indicated

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
04/17/2026
*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: R389591