Separation Scientist, Analytical R&D (Onsite) Full-time NEW

Scientist (R2) Biologics Analytical

We invite individuals who possess a deep passion for promoting lifesaving and life-enhancing products to join our dynamic team. Our team is highly dedicated and committed to offering exceptional scientific oversight, driving the success of our company's extensive range of products from candidate selection to market authorization. At our company, we proudly continue to build upon a legacy of groundbreaking innovation while steadfastly upholding the highest standards of ethics and integrity. With a diverse workforce representing a multitude of languages and cultures, we stand unified in our collective mission to deliver revolutionary medicines and products with integrity and transparency.

We are actively seeking an enthusiastic individual to join our Rahway, NJ team as a Scientist (R2) in Biologics Analytical Research & Development (AR&D) GMP Operations, to support separations methods (e.g. HPLC, UPLC, CE, iCIEF). In this role, the selected candidate will be responsible for method optimization, phase-appropriate validation, early and late-stage analytical transfers, 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, External Capabilities, 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

• Validate and implement analytical methods to support release and stability testing of clinical materials.
• Execute Good Manufacturing Practices (GMP) activities such as release, stability, and in-process testing of Biologics Drug Substance (DS) and Drug Product (DP).
• Act as subject matter expert (SME) across various franchises and analytical platforms.
• Support biologics registrations, product launches, and troubleshooting activities.
• Support compliance audits, inspection activities, and investigation/CAPAs.
• Author and review technical documents.
• Complete assigned work within established project timelines.
• Ensure adherence to GMP standards and facilitate ongoing enhancement of laboratory processes.
• Manage laboratory equipment, laboratory supplies, and critical reagent inventories.
• Additional responsibilities as assigned to support the evolving needs of the department.

Qualifications

• 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, or M.S. degree.

Experience and Skills

Required

• At least 1 year experience working in a GMP environment.
• Experience with separation techniques such as HPLC, UPLC, CE, iCIEF, or other advanced technology.
• Understanding and adherence to ALCOA principles for documentation.
• Strong organizational skills and ability to manage work to meet project timelines.
• Capability to work independently with minimal supervision.
• Ability to identify and resolve common technical issues.
• Effectively engage, communicate, and collaborate with others.
• Self-motivated with a positive attitude, strong interpersonal skills, and aptitude for learning.
• A willingness to occasionally work irregular hours, including evenings and weekends, as needed.

Preferred

• Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity.
• Knowledge of USP, EP, ICH, and FDA regulations.
• Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms.
• Experience with electronic notebooks.
• Experience with Mass Spectrometry analysis.
• Knowledge of deviation management and change control processes.

Adaptability, Analytical Development, Analytical Method Development, Bioanalysis, Cell-Based Assays, Change Control Processes, Fast-Paced Environments, FDA Regulations, Gas Chromatography-Mass Spectrometry (GC-MS), GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Mass Spectrometry (MS), Multidisciplinary Collaboration, Radioimmunoassay (RIA), Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Spectrometry, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

Required Skills: Adaptability, Analytical Development, Analytical Method Development, Bioanalysis, Cell-Based Assays, Change Control Processes, Fast-Paced Environments, FDA Regulations, Gas Chromatography-Mass Spectrometry (GC-MS), GMP Compliance, Good Manufacturing Practices (GMP), Immunoassays, Interpersonal Relationships, Laboratory Information Management System (LIMS), Laboratory Techniques, Mammalian Cell Culture, Mass Spectrometry (MS), Multidisciplinary Collaboration, Radioimmunoassay (RIA), Real Time Polymerase Chain Reaction (qPCR), Self Motivation, Spectrometry, Standard Operating Procedure (SOP) Writing, Technical Writing, Troubleshooting

Preferred Skills: Technical expertise with compendial testing such as visible and sub-visible particles, pH, osmolality, color, and/or clarity, Knowledge of USP, EP, ICH, and FDA regulations, Experience with LIMS, Empower, electronic notebook, and/or other data analytics platforms, Experience with electronic notebooks, Experience with Mass Spectrometry analysis, Knowledge of deviation management and change control processes

The salary range for this role is $85,600.00 – $134,800.00. 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: 10/11/2025

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