Senior Scientist - Bioassay Analytical R&D; Onsite

# Senior Scientist - Bioassay Analytical R&D (Onsite)
Merck Rahway, NJFull-Time Oct 07, 2026

Science##

Job Description
** Job Description
***
* Job Summary:

** We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Senior Scientist (R3) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support ELISA and cell-based methods. In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage transfers, Soft Max Pro template validation, analytical life cycle management, and release and stability testing.

The successful candidate must be able to work in a fast-paced, multidisciplinary environment and will play a pivotal role supporting Biologics to advance commercialization efforts.  The incumbent will collaborate closely with various stakeholders, including Analytical Development, Large Molecule Assay Validation, Quality Assurance, Technical Operations, and CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to progress the pipeline.

** Responsibilities:*
* * Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP) using both traditional and advanced analytical tools.
* Validate and implement biologics methods to support release and stability testing of clinical materials.
* Support critical reagent qualifications and Soft Max pro template validation activities.
* Act as subject matter expert (SME) across various franchises and analytical platforms.
* Support biologics registrations, product launches, and troubleshooting activities.
* Develop and manage project timelines and deliverables.
* Support compliance audits, inspection activities, and investigation/CAPAs.
* Advance strategic initiatives across matrixed teams.
* Author and review technical documentation including regulatory submissions.
* Additional responsibilities as assigned to support the evolving needs of the department.  
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* Qualifications:

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* * Ph.D. in biology, biochemistry or related field or M.S. with a minimum of 3 years of relevant experience or B.S. with a minimum of 7 years of relevant experience.
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* Experience and Skills:

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* ** Required*
* * Deep technical expertise with immunoassays and/or cell-based potency methods.
* Proficiencies with mammalian cell culture and ELISAs.
* Strong organizational skills with proven ability to manage timelines and deliverables.
* Ability to pro-actively identify and communicate risks.
* Demonstrated capability of finding innovative solutions to technical issues.
* Capability to work independently and within a matrixed team.
* Effective communication (oral and written) and leadership skills.
* Strong interpersonal skills with adeptness to lead by influencing others.
* Self-motivated with a positive attitude and proven performance record.
* A willingness to occasionally work irregular hours, including evenings and weekends, as needed.  
** Preferred*
* * GMP experience is highly preferred.
* Experience with LIMS, Soft Max Pro, electronic notebook, and/or other data analytics platforms.
* Knowledge of cGxP operation, USP, EP, ICH, and FDA guidelines.
* Experience with analytical method validation and life cycle management.
* Deviation management and change control processes.
* Experience with method development or regulatory submissions.
* Experience with Soft Max Pro template creation is highly preferred.
* Experience with residual assays, qPCR, capillary electrophoresis, chromatographic separations or compendial methods is desirable.eligibleforERP
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* Required Skills:

** Cell-Based Assays, Cell…