Principal Scientist - Biologics Potency, Cell Based Sciences, Analytical R&D

Job Description

The Analytical Research & Development, Cell Based Sciences in Rahway, NJ is seeking a motivated senior level scientist with extensive experience in biologics potency assays. More specifically, the ideal candidate will be a recognized expert developing mechanism-of-action reflective potency assays for the development of therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or complex modality-based products.

Key Responsibility:

• Responsible for providing scientific leadership and mentoring, expertise, and creativity in defining potency strategies, method development and problem solving for complex projects across the large molecule portfolio.
• Oversight of developing MoA-reflective potency methods using innovative and state-of-the-art analytical techniques and approaches, and generation of technical reports
• Support method transfers to internal and external GxP laboratories
• Represent the potency group on cross-functional product development teams and effectively communicate with stakeholders in partner organization and to management and governance teams.
• Support regulatory filing by authoring and reviewing regulatory submissions and interacting with Health Authorities.

Education, Qualifications, and Skills:

• Ph.D. in cell biology, immunology, biochemistry, molecular biology, or related field with a minimum of 8 years of relevant industry experience; OR M.S. with a minimum of 10 years of relevant industry experience; OR B.S with a minimum of 14 years of relevant experience in the pharmaceutical industry.
• Expertise in applying advanced cell biology and immunology to solve complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities. Experience in complex modality-based biologics development is a plus.-
• Expertise in a variety of potency assay technologies, such as immune binding assays, cell line engineering, cell-based reporter gene assay development, flow cytometry, effector function assays.
• Strong knowledge and statistical skills for interpretation of potency data in context of broader process and product development.-
• Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with Health Authorities.
• External scientific engagement including publications, industry white paper contributions, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia.
• Ability to excel in a team-based environment, partnering and influencing in a professional and positive manner.
• Excellent verbal and written communications skills

#AR&D

Required Skills:
Analytical Method Development, Assay Development, Bioanalytical Analysis, Chromatographic Techniques, Clinical Judgment, Communication, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Liquid Chromatography (LC), Management Process, Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Social Collaboration, Stability Testing, Technical Writing

Preferred Skills:

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:

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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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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
$153,800.00 - $242,200.00

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/International

VISA Sponsorship:
Yes

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
Yes

Hazardous Material(s):
N/A

Job Posting End Date:
11/28/2025
*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: R357945