Job Description

Scientist (R2) Bioassay
North American GMP Operations, Rahway, NJ

We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) Good Manufacturing Practices (GMP) Operations, to support bioassay analysis, including 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, SoftMax Pro template validation, cell line maintenance, 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 analytical methods to support release and stability testing of clinical trial materials.
• Support critical reagent qualifications and SoftMax pro template validation activities.
• Document activities in a detailed and organized manner and follow SOPs.
• Author and review technical documents.
• Complete assigned work within established project timelines.
• Support GMP compliance and continuous improvement of laboratory operations.
• Manage laboratory supplies and critical reagent inventories.
• Additional responsibilities as assigned to support the evolving needs of the department.

Experience and Skills

Required

• Minimum of a B.A./B.S. degree in biology, biochemistry, or related scientific field with 3 years of relevant experience in analytical development, validation, and/or quality control, master's degree preferred.
• Additional responsibilities as assigned to support the evolving needs of the department.
• Experience with mammalian cell culture and ELISAs.
• Additional responsibilities as assigned to support the evolving needs of the department.
• Document activities in a detailed and organized manner following SOPs.
• Ability to manage work to meet project timelines.
• Capability to work independently with minimal supervision.
• Ability to identify and resolve common technical issues.
• Effectively communicate, collaborate, and engage with others.
• Agile learner who is self-motivated with a positive attitude.
• A willingness to occasionally work irregular hours, including evenings and weekends, as needed.

Preferred

• GMP experience is preferred.
• Experience with LIMS, SoftMax Pro, electronic notebook, or other data analytics platforms.
• Knowledge of assay validation requirements is highly preferred.
• Understanding of cGxP operation, USP, EP, ICH, and FDA guidelines.
• Experience with SoftMax Pro template creation is preferred.
• Familiarity with deviation management and change control processes.
• Experience with method development, qPCR, capillary electrophoresis, chromatographic separations and/or compendial methods is desirable.

#AR&D

#eligibleforERP

Required Skills:
Biochemistry, Cell-Based Assays, Cell Cultures, Collaborative Communications, Fast-Paced Environments, Good Manufacturing Practices (GMP), Immunoassays, Immunochemistry, Interpersonal Relationships, Laboratory Techniques, Maintenance of Cell Lines, Mammalian Cell Culture, Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Standard Operating Procedure (SOP) 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.

The salary range for this role is
$87,300.00 - $137,400.00

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.

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

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:
07/21/2026
*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.