Associate Director Manufacturing Support Devens Clinical MFG

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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.

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.

One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together, we are driven to make a difference, from innovative research to hands-on community support.

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 the resources to pursue their goals, both at work and in their personal lives.

Reporting to the Director, Single Use Facility, the Associate Director, Manufacturing Support and his/her team is responsible for providing technical and project management leadership associated with the transfer and manufacture of drug substance designated for clinical/commercial launch use. The Single Use Facility (SUF) is a new, state of the art facility utilizing disposable technology.

Key responsibilities include, but are not limited to coaching and leading a team that:


Leads the technical transfer and scale-up of biological processes from process development into clinical phase manufacturing. Oversees authoring of facility fit reports and schedule adherence to all aspects of the tech transfers. Identifies and assists in the implementation of new technologies/procedures from Development into Operations.
Authors relevant sections of exception documentation (Investigations, Deviations), providing a thorough root cause analysis and product impact assessments, while recommending appropriate Corrective Action and Preventive Actions (CAPA). Supports investigations as a project manager to ensure timely closure of the investigations.
Supports processing via in-plant coverage and troubleshooting process upsets, as well as identify opportunities for process improvements. Collates data from manufacturing, performing statistical analysis to trend and track process performance, culminating in campaign summary reports.
Provides project management support for tech transfers and site enhancement projects.
Manages and leads prioritization of 'Book of Work' activities that incorporate OpEx, CAPA and robustness projects involving cross-functional support teams. Additionally,
Recruits and develops a high performing team with diverse backgrounds and talents. Coaches and counsels team members to develop their skill sets and create an environment of continuous learning, improvement, and innovation.
Establishes an environment which fosters safety, quality and continuous improvement in cost and customer service. Maintains and communicates performance metrics, setting and maintaining high expectations for team performance.


Qualifications:


B.S. in science, engineering or biochemistry or related field required. A Master's or PhD in science, engineering or biochemistry is desirable.
A minimum of 10 years relevant experience in a biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations is required.
Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected.
Experience with managing tech transfers of new products into a clinical manufacturing facility
Demonstrated good interpersonal and communication skills.


Preferred:


Previous supervisory experience preferred.
Previous experience with Operation Excellence is a plus.
Knowledge of single-use equipment is desirable.


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.

Company: Bristol-Myers Squibb

Req Number: R1526962_EN

Updated: 2020-06-29 00:00:00.000 UTC

Location: Devens,Massachusetts

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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