Bristol Myers Squibb Senior Manager, QA Technical Operations, Process Lead in Devens, Massachusetts
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.
PRINCIPAL OBJECTIVE OF THE POSITION:
The Senior Manager, Quality Assurance Technical Operations, Process Lead maintains responsibility for all routine quality assurance activities associated with GMP process sciences in Devens. This is inclusive of technology transfer activities in the Large Scale Cell Culture (LSCC) facility and Single Use Facility (SUF). The Process Lead will provide direct Quality Assurance support to the Manufacturing Sciences & Technology group and represent QA in relevant drug substances forums.
Major Duties and Responsibilities:
Quality oversight of biologics process Technology Transfer activities at the Devens site.
Quality oversight of process related protocols, studies or activities related to GMP biologics processes.
Quality oversight of the statistical process control (SPC) programs for commercial biologics processes.
Represent Devens site quality on relevant biologics drug substance teams.
Support process related health authority inquiries related to drug substance manufacturing in Devens.
Quality oversight of process validation activities, including development of In Process Control strategy and process validation protocols.
Leads risk assessment activities to document risk based decision making.
Performs review and approval of site and department SOPs.
Directly participates in internal audits as well as global health authority inspections.
Commitment to act in accordance with BMS’ values: Integrity, Innovation, Urgency, Passion, Accountability, and Inclusion.
Knowledge and Skill Requirements:
Bachelor’s or graduate degree in a scientific or engineering discipline, or its equivalent is required. Advanced degree in Regulatory Affairs is highly desirable.
A minimum of 10 years of relevant experience including experience working in within or supporting a GxP-regulated function.
Knowledge of biotech bulk and finished product manufacturing, and analytical testing is highly desirable.
Proven knowledge of biologics processes and quality risk management.
Experience with risk assessment tools and their application to drug substance manufacturing.
Demonstrated ability for flexibility and capability of managing multiple tasks in a fast paced environment.
Demonstrated ability and excellent organizational and time management skills as to effectively prioritize work.
Detail oriented with a sense of urgency for completing tasks independently and without detailed direction.
Experience implementing and execution of compliance related programs.
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.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
Company: Bristol Myers Squibb
Req Number: R1541865
Updated: 2021-06-23 02:53:25.390 UTC
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, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.
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