Assoc Prin. Scientist, Analytical R&D; 2nd Shift: Lead

Job Description

Associate Principal Scientist 2nd Shift GMP Supervisor, Pharmaceutical Analytical Sciences

Location:

Rahway, NJ

Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

This particular role is fully onsite during 2nd shift operations (3pm — 11:30pm).

• Serve as a scientific and operational supervisor for a team of specialists and scientists supporting cleaning verification, solvent release, and in-process testing for drug substance and drug product during 2nd shift operations.
• Support execution of Good Manufacturing Practices (GMP) analytical activities such as method validation and release testing.
• Document the execution, procedure, results, and conclusions of experiments 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 lab investigations and deviations and troubleshoot in the lab as necessary.
• Review and approve GMP data, analytical reports, and SOPs.
• Ensure operational excellence and drive process improvements.
• Work collaboratively with internal stakeholders and partners such as Global Development Quality and Pharmaceutical Operations.
• Support internal and external compliance audit activities.

• Education:
  
  BS or MS in chemistry or a related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.
• Education:
  
  Ph.D. in chemistry or a related science with at least 3 years of industry experience with pharmaceutical drug substance and/or product development.
• 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 with cross‑functional interactions to drive results.
• Prior experience managing a GMP analytical lab that supports cleaning verification, IPC, and solvent release.
• Prior experience with lab investigations, deviations and compliance audits is a plus.
• Experience in analytical method development, analytical testing, cross‑functional teamwork, GMP compliance, manufacturing operations, operational excellence, science communication, and team leadership.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.

For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit EEOC Know Your Rights, EEOC GINA Supplement, and learn more about your rights, including under California, Colorado and other U.S. State Acts.

Salary range: $ – $. The successful candidate will be eligible for annual bonus and long‑term incentive, if applicable. Benefits include medical, dental, vision, healthcare, retirement benefits, paid holidays, vacation, and compassionate and sick days.

US and Puerto Rico Residents Only. 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.