Associate Principal Scientist, Analytical R&D (GxP Supervisor 2nd Shift)
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 for the non-sterile clinical portfolio, including cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product. The role works during second-shift operations and also provides hands-on analytical laboratory support to enable the pipeline. The position ensures timely, right-first-time analytical testing for clinical manufacturing; provides technical and compliance oversight of investigations and deviations; reviews and approves GMP data, analytical reports, and SOPs; and drives operational excellence and process improvements. It works collaboratively with internal stakeholders and partners, including Global Development Quality and Pharmaceutical Operations, and supports internal and external compliance audits.
Requirements
- Bachelor's or master's degree in chemistry or a related science and at least 7 years of industry experience in pharmaceutical drug substance and/or product development; or 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 interact 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 that supports cleaning verification, in-process control (IPC), and solvent release.
- Prior experience with laboratory investigations and deviations and compliance audits.
Responsibilities
- Scientifically and operationally supervise a team supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during second-shift operations.
- Support the execution of GMP analytical activities, including cleaning verification, method validation, and in-process testing.
- Document experimental execution, procedures, results, and conclusions in a detailed and organized manner in accordance with 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 needed.
- 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.
- Provide hands-on analytical laboratory support to enable the pipeline.
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Other insurance benefits for employees and family
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate days
- Sick days
- Annual bonus eligibility
- Long-term incentive eligibility, if applicable
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What This Job Offers
Job Type
Full-time
Career Level
Senior
