Bristol Myers Squibb QA OPERATIONS DISPOSITION LEAD in Devens, Massachusetts

PRINCIPAL OBJECTIVE OF THE POSITION:

  • Coordinate the receipt of deliverables to support Drug Substance disposition from cross-functional responsible parties. Provide for review of disposition deliverables and preparation of Drug Substance disposition package for Quality Management signatories and disposition of batches with inventory management systems. Assure the quality of manufactured products is in compliance with all applicable regulations and guidelines. Provide redundancy support of release of raw material and consumable materials as well as review of in-process electronic batch records to support disposition project initiatives.

  • Executes operating procedures for the site quality assurance program, which assures material release (raw and in-process materials as well as finished product). This includes the coordination of receipt of deliverables required for material disposition from cross-functional responsible parties. Prepares Drug Substance disposition package in accordance with SOPs for Quality Management signatory. Responsibilities also include updates to Drug Substance lot status in applicable quality systems.

  • Performs complex manufacturing formulation electronic batch production record reviews and approval in support of product release in accordance with specifications and SOPs.

  • Provides guidance to less experienced staff with atypical events during day-to-day operations.

  • Performs review and approval of electronic recipe text changes used in the production of bulk Drug Substance.

  • Provides back-up support for the inspection and release of consumable and raw materials in accordance with written SOPs and specifications.

  • Other duties may include:

  • Authoring and review of SOPs.

  • Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained. Includes the documentation, follow up and escalation of observations and areas of concern.

Key Core behavioral indicators for this role include:

  • Participates in the creation of a team-based environment, promoting candor, collaboration, receptivity, clarity of purpose and goals, and high commitment to achieve business goals. Demonstrates appropriate examples of compliance behaviors and attitudes.

Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry or related discipline, or its equivalent is preferred.

  • A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.

  • Knowledge of biotech bulk and finished product manufacturing, Drug Substance or Drug Product disposition and batch record review is highly desirable.

  • Knowledge of US and EU cGMP regulations and guidance.

  • Knowledge of electronic systems including any of the following: SAP, LIMS, TrackWise, and electronic batch recording systems, is desirable. Microsoft Office Suite knowledge and proficiency with Excel is desirable.

  • Knowledge in Operational Excellence and Continuous Improvement is desirable.

  • Excellent writing and oral communication skills are required.

  • Previous work responsibility, which required a high degree of attention to detail.

  • Well practiced in exercising sound judgment in decision-making.

  • Demonstrated multitasking and organization skills.

Past experience where one was required to work in a team based environment with a diverse group of people.

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.