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

Job Description

Role Summary:

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.

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 cleaning verification, method validation and in-process 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:

• 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, 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, Regulatory Compliance Audits

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

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​

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

Learn more about your rights, including under California, Colorado and other US State Acts

The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

…