Bristol Myers Squibb Laboratory Manager– Analytical Strategy & Operations- Biologics GxP Development in Hopewell, New Jersey
Versatile, biologics development GxP (GMP/GLP) laboratory seeks a hard-working, results-focused Laboratory Manager with significant knowledge of separation analysis, GLP and GMP regulations applicable to the analytical laboratory and biologics product development to bring a world-class R&D Biologics portfolio to market. This position will be a part of the Biologics GxP group within Analytical Strategy & Operations (ASO) under the Product Development (PD) organization. The Laboratory manager will supervise bio-separation scientists and supporting staff, and mentor and develop talent. Provide strategic leadership in resource allocation and prioritization of analyses to assure alignment of department objectives and timely execution of experiments to support clinical development programs, including release testing of drug substance/drug product, GLP/toxicology studies, use time studies, method validation and transfer experiments. Assure technical and quality merit of data. Drive operational excellence, including support for efficiency/productivity initiatives, and GxP/safety compliance. Provide leadership to resolve analytical investigations and technical issues. The position will be located at the BMS site in Hopewell, NJ and report to the Director, ASO- Biologics GxP.
Essential Duties and Responsibilities include, but are not limited to, the following:
Lead modern biologics laboratory responsible for biologics assays on monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products to support clinical development of therapies, particularly against immuno-oncology (IO) and oncology diseases.
Responsible for assuring technical merit and quality elements (GDP, GLP/GMP compliance) of data generated within the laboratory with a focus on protein separations methods (chromatographic, e.g. SE-HPLC, N-glycan analysis, CEX, RP-HPLC, Protein A titer assay, peptide mapping and electrophoretic, e.g. iCIEF and CE-SDS). Data are essential to support Research & Development (e.g. clinical release, stability, re-assay, use time, GLP test article characterization and dosing solution studies, reference standard qualification, method qualification/validation/transfer and comparability).
Manage day-to-day laboratory operations for protein separations analysis, including prioritizing samples and studies, scheduling analyst assignments, and tracking timely progress of critical samples and studies to support project timelines. Provide reports on department output that evaluate operating effectiveness.
Drive performance and engagement, mentor and promote professional development of direct reports.
Provide strategic direction, guidance and technical oversight in the planning and execution of experiments and in the review and approval of biologics 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 partner QC laboratories.
Initiate and support programs to improve lab operations efficiency, productivity and/or compliance, including new technology initiatives.
Assure full compliance with relevant Good Laboratory Practice (GLP) or Good manufacturing Practice (GMP) regulations, corporate policies and site procedures in laboratory operations.
Review CMC sections for regulatory filings (e.g. IND, BLA)or Health Authority response as required.
Collaborate with key internal, including Method Development, Clinical Manufacturing and Quality, and external partner organizations (CROs) to align goals, deliver R&D biologics portfolio milestones and drive continuous improvement.
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.
Minimum of 3 or more years of people management (i.e. supervisory) experience is strongly preferred, particularly in analytical laboratory
Demonstrated ability to lead teams, including cross-functional initiatives.
In-depth understanding of methodology and data interpretation in separations (e.g. chromatographic, electrophoretic).
Thorough understanding of cGMP/GLP and GDPs practices is essential. Preferred candidate will possess significant experience in a GMP environment.
The candidate must possess excellent written and verbal communication skills. Must be able to successfully negotiate and collaboratively resolve issues.
Expertise using Empower, Electronic Laboratory Notebook (Velquest and Symyx), Laboratory Information Systems (LIMS) and MS Office applications, in particular MS Word and Excel, is preferred.
Broad experience/understanding of CMC development for biologics, including monoclonal antibodies, fusion proteins, antibody-drug conjugates (ADCs) and fixed drug ratio combination (FDRC) products is a plus.
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.