Director, Biologics Quality Control Operations

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity. Take your career farther than you thought possible.

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. Read more: careers.bms.com/working-with-us.

Required Skills & Knowledge:

• Minimum Bachelor’s Degree, preferably Master’s in biological science or related field. 

• At least 10 years’ experience in biopharmaceutical technical operation areas with minimum of 6 years of increasing management responsibility. 

• In-depth knowledge of analytical biochemistry quality control  procedures, and the application and interpretation of GMP concepts and compendia requirements (e.g. USP, CFR) to daily laboratory operations.

• OPEX experience or certification preferred

• Knowledge of laboratory equipment, instrumentation, and techniques.

• Must have demonstrated ability to plan, implement, and achieve significant, complex goals and objectives.

• Demonstrated ability to work with and manage people in a complex, changing environment to deliver value added results to the organization. 

• Strong background and demonstrated effectiveness in quality assurance and regulatory compliance of commercial biologics in a Globally regulated environment. 

• Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.  Ability to lead and motivate people.

• Ability to network globally within BMS and externally to stay current with latest requirements/trends/initiatives.

• Experience in building and growing an organization, and ability to lead and motivate people.

• Ability to manage change effectively.

• Knowledge of biotech bulk and finished product manufacturing as well as analytical testing.

• Be very familiar with US and EU cGMP regulations and guidance.

• Experience with direct FDA, EMA, and Global HA interactions including face-to-face interactions and/or regulatory filings.

• Demonstrated leadership skills and outstanding interpersonal, communication and motivation skills.

• Strong interpersonal and communication skill set to effectively manage a diverse population of scientists across multiple scientific disciplines.

• Ability to embrace collaboration with partners, customers, and team members, operate with integrity, as well as seek and participate in the continuous improvement of systems and culture.

• Ability to build relationships cross functionally and influence internally/externally as appropriate.

Responsibilities:

Lab Functions

• Own the operation of QC analytical laboratories supporting all raw material, in-process, release, microbial, utility, and environmental testing for molecules manufactured in the LSCC and SUF facilities in Devens, as well as all BMS commercial DS and DP biologics stability testing.

• Own the supporting functions within QC of sample management, equipment lifecycle, investigations, and data evaluation.

The QC leadership structure

• Lead the analytical transfers required for new or modified methods for raw materials, in-process, release, or stability tests based on company testing strategies.

• Provide microbial ID testing for the Devens Cell Therapy Facility, as required.

• Own the Environmental Action Committee with oversight and accountability for the performance of the site’s environmental controls program.

• Rapidly respond to OOS and OOT results to support completion of timely and robust investigations.  Actively engage in product disposition and supply disruption discussions resulting.

• Develop and enhance the quality system to promote, facilitate and assure compliance with all regulatory and BMS standards

• Maintain inspection-ready laboratories at all times.  Proactively improve systems to ensure data integrity, compliance wit