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

Job Description

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

  

The Pharmaceutical Analytical Sciences group has an exciting opportunity for an Associate Principal Scientist 2nd Shift GMP Supervisor based in 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.  

The Associate Principal Scientist will serve as the scientific and operational supervisor for a team of specialists and scientists in Rahway supporting various GMP analytical activities including cleaning verification, method validation, solvent release, and in-process testing for drug substance and drug product across the entirety of our non-sterile clinical portfolio during 2nd shift operations at the Rahway site. The role will also require hands-on analytical lab support to enable the pipeline. 

This particular role is fully onsite during 2nd shift operations (3pm – 114:30pm). 

Your main responsibilities will include: 

Primary Responsibilities:

• 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 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 to troubleshoot in the lab as necessary

• Review and approval of 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.

Qualifications

Education Minimum Requirements ​

Applicants must hold one of: ​

• BS or MS in chemistry or related science with at least 7 years of industry experience with pharmaceutical drug substance and/or product development.

• Ph.D. in chemistry or related science with at least 3 years of industry experience with pharmaceutical drug substance and/or product development.

Required Experience and Skills 

• 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.

Preferred Experience and Skills ​

• 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.

#AR&D

Required Skills:

Analytical Method Development, Analytical Testing, Cross-Functional Teamwork, GMP Compliance, Manufacturing Operations, Operational Excellence, Science Communication, Team Leadership

Preferred Skills:

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As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the