Job Description

At Bristol Myers Squibb, we are inspired by a single vision transforming patients lives through science. In oncology, hematology, immunology and cardiovascular disease and one of the most diverse and promising pipelines in the industry each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This position primarily supports the Devens Single Use Manufacturing Facility (SUF) and the Devens Cell Bank Facility (CBF). The candidate will provide oversight to quality assurance disposition and master data programs to support clinical and commercial drug substance and cell bank manufacture. Primary responsibilities include the following:

* Executes operating procedures for the site quality assurance program, which supports the disposition of manufactured products. This includes the coordination of receipt of deliverables required for material disposition from cross-functional responsible parties. Prepares disposition documents in accordance with SOPs for Quality Management approval. Responsibilities also include updates to lot status in applicable quality systems.
* Primary contact for Cell Bank disposition and network re-evaluation activities
* Management of SAP and Syncade Master Data program
* Provides guidance to less experienced staff with atypical events during day-to-day operations.
* Provides back-up support for the inspection and release of consumable and raw materials in accordance with written SOPs and specifications.
* Other responsibilities include:
* Authoring and review of SOPs.
* Leading DS disposition visual mgmt. process
* Review of change controls to determine the need for market controls, and implementation of market controls when applicable.
* QA Operations SME for SAP
* SME for disposition process for regulatory inspections
* 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.

May also perform manufacturing batch record review, master batch record approval and other activities in support of the quality assurance operations team.

Experience Required:

* A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality.
* Knowledge of US and EU cGMP regulations and guidance.
* 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, deviation investigations 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.

Work is performed in a modern office environment and requires extensive computer work. Additionally, work is performed in manufacturing facility, as well as support GMP areas, with environmental classified areas requiring appropriate personal protective equipment (PPE) and potential exposure to chemical hazards, pressurized gases and hot surfaces. Work will be primary remote until after the COVID-19 restrictions are lifted.

BMS/BL

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.