USA - New Jersey - Rahway, United States of America
Onsite
Job Description
Large Molecule Analytical within our Company's Research Laboratories is seeking a highly motivated senior scientist with extensive experience developing potency assays for biologics to join the Biologics Potency team within Cell-Based Sciences in Rahway, New Jersey. The successful candidate will apply scientific expertise and creativity to solve complex project challenges across the large molecule portfolio, including therapeutic proteins, monoclonal antibodies, antibody-drug conjugates, and/or complex modality-based products. The candidate should cultivate and foster scientific and technological innovation, leverage external networks to stay current on industry best practices and emerging technologies in potency assay development, champion new initiatives, and enhance functional capability and operational excellence.
Key Responsibilities:
Define potency strategy and develop and optimize immune binding assays and cell-based assays for biologics development.
Conduct non-GMP qualification and robustness studies and perform non-GMP sample testing.
Support potency method transfers and validation at GxP testing laboratories.
Represent potency on cross-functional product development teams.
Contribute to the authoring and review of regulatory submissions and technical reports.
Provide scientific mentoring to junior scientists.
Communicate effectively with stakeholders in partner organizations, management, and governance teams.
Maintain accurate and detailed laboratory records.
Qualifications:
Ph.D. in cell biology, immunology, biochemistry, molecular biology, or a related field with a minimum of 4 years of industry experience in the biopharmaceutical industry; M.S. in cell biology, immunology, or a related field with a minimum of 8 years of relevant industry experience; or B.S. in cell biology, immunology, or a related field with a minimum of 12 years of relevant industry experience.
Expertise in cell biology and immunology, with application to solving complex scientific and operational challenges related to designing and developing GxP potency assays to support a variety of large molecule modalities; experience in new modality-based therapy development is preferred.
Hands-on experience developing immune binding assays and cell-based functional assays, with proficiency in a variety of biological and immunological techniques, such as stable cell line generation, cytotoxicity assays, ELISAs, flow cytometry, and reporter gene assays.
Working knowledge of Quality by Design (QbD) and Design of Experiments (DOE) principles, as well as strong statistical skills for data interpretation in the context of broader process and product development.
Proficiency in common bioassay software and data analysis packages, such as SoftMax Pro, JMP, PLA software, GraphPad Prism, and Microsoft Office tools.
Experience mentoring peers and junior scientists.
Working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing regulatory submissions and responses and interacting with health authorities.
Track record of scientific engagement, which may include scientific publications, industry white paper contributions, and presentations at scientific meetings.
Ability to excel in a team-based environment by partnering and influencing in a professional and positive manner.
Demonstrated ability to deliver complex objectives and work effectively in a collaborative, fast-paced, and dynamic cross-functional team environment.
Excellent verbal and written communication skills.
#AR&D
Required Skills:
Analytical Method Development, Antibody Drug Conjugates (ADC), Assay Development, Biological Assay Development, Biopharmaceutical Industry, Biopharmaceuticals, Biopharmaceutics, Cell-Based Assays, Cell Physiology, Chromatographic Techniques, Cytotoxicity, High Resolution Mass Spectrometry (HRMS), Immunoassays, Immunology, Liquid Chromatography-Mass Spectrometry (LC-MS), Mass Spectrometry Analysis, Molecular BiologyPreferred Skills:
Cell BiologyCurrent Employees apply HERE
Current Contingent Workers apply HERE
US and Puerto Rico Residents Only:
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The salary range for this role is
$142,400.00 - $224,100.00This 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.
You can apply for this role through https://jobs.merck.com/us/en (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
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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:
RegularRelocation:
VISA Sponsorship:
Travel Requirements:
Flexible Work Arrangements:
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Hazardous Material(s):
Job Posting End Date:
07/25/2026*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.