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 drug substance and drug product across the non-sterile clinical portfolio, including cleaning verification, method validation, solvent release, and in-process testing during second-shift operations. The role also provides hands-on analytical laboratory support to enable the pipeline. The position is responsible for helping ensure timely, right-first-time analytical testing that supports clinical manufacturing. It provides technical and compliance oversight for laboratory investigations and deviations, supports troubleshooting, and reviews and approves GMP data, analytical reports, and SOPs. The role works with internal stakeholders and partners, including Global Development Quality and Pharmaceutical Operations, and supports internal and external compliance audits. The employee is eligible for an annual bonus and long-term incentive, if applicable. The posting lists domestic relocation and visa sponsorship as available, and travel requirements of 10%.
Requirements
- Bachelor’s or master’s degree in chemistry or a related science and at least 7 years of industry experience with 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 work cross-functionally to drive results.
Nice To Haves
- Prior experience managing a GMP analytical laboratory supporting cleaning verification, in-process control (IPC), and solvent release.
- Prior experience with laboratory investigations and deviations, and compliance audits.
- 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.
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 timely, 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.
- Provide hands-on analytical laboratory support to enable the pipeline.
Benefits
- Medical, dental, vision healthcare, and other insurance benefits for employees and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, compassionate days, and sick days.
- Annual bonus and long-term incentive, if applicable.
- Domestic relocation is listed as available.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Senior
