Bristol Myers Squibb GxP Laboratory Manager, Pharma Raw Materials in New Brunswick, New Jersey
Position Description and Role :
Versatile, Analytical GxP laboratory seeks a hard-working, results-focused Laboratory Manager to lead a team responsible for the execution of analytical activities (development, validation, transfer and analysis) related to the GMP testing of pharmaceutical materials, including but not limited to active pharmaceutical ingredient (API), finished drug product, and the raw materials and excipients used in the manufacture of both. The laboratory manager will possess knowledge of compendial testing (e.g. USP/EP), spectrophotometric (e.g. FTIR, NIR) and separations analysis (e.g. HPLC) and GMP regulations applicable to the analytical laboratory. Focus of the team will be on small molecule (i.e. chemical) materials/assets in the clinical development space (IND to NDA stage), but analysis of biologics in the R&D portfolio are within scope of responsibilities. The Laboratory manager will supervise scientists, mentor/develop talent, and provide strategic and technical leadership in resource allocation, prioritization, and resolution of analytical investigations and technical issues. The successful candidate must also effectively collaborate with customers and stakeholders throughout Product Development (PD), including Clinical Supply Operations, Chemical and Synthetic Development, Drug Product Science and Technology, and Global Quality. This position will be a part of the Biologics GxP group within Analytical Strategy & Operations (ASO) under the PD organization, and directly reporting to the Director- ASO, Biologics GxP.
Duties & Responsibilities :
Essential Duties and Responsibilities include, but are not limited to, the following:
Manage an analytical laboratory staffed by 3-5 scientists and technicians. Execute and oversee activities involving method development, validation, and routine testing. Oversee the qualification (initial and periodic) and operational use of analytical equipment and related data systems. Evaluate resource requirements to support incoming work and ensure all project timelines are met.
Provide strategic direction, guidance and technical oversight in the planning and execution of experiments and in the review and approval of analytical method qualification/validation/transfer protocols and reports to assure that reliable, fit-for-purpose and phase-appropriate assays are established within the department and at partner QC laboratories.
Create, revise, review and approve GMP analytical documentation including protocols and reports associated with methods, validations, transfers, investigations and instrument qualifications. Generate, review and approve analytical data related to the GMP testing of APIs, drug products and materials used in the manufacture of both.
Possess technical knowledge in relevant analytical techniques and methodologies to enable troubleshooting technical problems and oversight of analytical investigations
Possess strong knowledge of GMP regulations and ensure adherence to cGMP and ICH requirements.
Collaborate with regulatory to support IND CMC filings, amendments and revisions.
Train and develop direct reports on job related functions and in technical disciplines. Facilitate career advancement for team members through coaching and execution of development plans.
Initiate and support programs to improve lab operations efficiency, productivity and/or compliance, including new technology initiatives.
Professional Qualifications :
The candidate must have a B.S. or equivalent with 8-10 or more years relevant experience or a M.S. with 6 or more years relevant experience or a Ph.D. with 4 or more years relevant experience in biotechnology/pharmaceutical industry with a degree in Analytical Chemistry, Chemistry, Biochemistry or equivalent.
Thorough understanding of cGMP is essential. Preferred candidate will possess at least 5 years of experience in a GMP environment, preferably in an analytical laboratory.
Minimum of 3 or more years of people management (i.e. supervisory) experience is strongly preferred, particularly in analytical laboratory. Demonstrated ability to develop/mentor talent and build/lead a high performing team is preferred.
The candidate must possess excellent written and verbal communication skills. Must be able to successfully negotiate and collaboratively resolve issues.
Knowledge of compendia requirements (e.g. USP/EP) pertinent to analytical laboratory is desired.
Expertise using Electronic Laboratory Notebook, Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred.
Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.