Associate Principal Scientist, Analytical R&D (GxP Supervisor 2nd Shift)

Merck • Rahway, NJ

7d • $142,400 - $224,100 • Onsite

About The Position

The Associate Principal Scientist serves as the scientific and operational supervisor for a team of specialists and scientists at the Rahway site. The team supports GMP analytical activities across the non-sterile clinical portfolio, including cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product during second-shift operations. The role also provides hands-on analytical laboratory support to enable the pipeline.

Requirements

• A BS or MS in chemistry or a related science and at least 7 years of industry experience with pharmaceutical drug substance and/or product development; alternatively, a Ph.D. in chemistry or a related science and at least 3 years of such industry experience.
• Excellent scientific communication skills.
• Demonstrated creativity.
• Effective interpersonal and collaborative skills.
• Demonstrated ability to lead teams to deliver high-quality results against firm deadlines.
• Ability to partner in a team environment and work cross-functionally to drive results.
• Skills listed: Analytical Method Development, Analytical Testing, Assay Development, Biological Assay Development, Cell-Based Assays, Chromatographic Techniques, Cleaning Validations, Drug Development, High Resolution Mass Spectrometry (HRMS), Liquid Chromatography-Mass Spectrometry (LC-MS), Pharmaceutical Process Development, Process Analytical Technology (PAT), Protein Analysis, and Regulatory Compliance Audits.

Nice To Haves

• Prior experience managing a GMP analytical laboratory supporting cleaning verification, IPC, and solvent release.
• Prior experience with laboratory investigations, deviations, and compliance audits.

Responsibilities

• Supervise a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during second-shift operations.
• Support execution of GMP analytical activities, including cleaning verification, method validation, and in-process testing.
• Document experiment execution, procedures, results, and conclusions in a detailed and organized manner following ALCOA+ principles.
• Ensure on-time, right-first-time analytical testing to enable clinical manufacture of drug substance and drug product.
• Provide technical and compliance oversight for laboratory investigations and deviations, and troubleshoot in the laboratory as necessary.
• Review and approve GMP data, analytical reports, and SOPs.
• Ensure operational excellence and drive process improvements.
• Collaborate with internal stakeholders and partners, including Global Development Quality and Pharmaceutical Operations.
• Support internal and external compliance audit activities.

Benefits

• Medical, dental, and vision healthcare benefits.
• Other insurance benefits for employees and family.
• Retirement benefits, including 401(k).
• Paid holidays.
• Vacation.
• Compassionate and sick days.
• Annual bonus and long-term incentive, if applicable.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior