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Associate Director, Manufacturing Technology (Process Technical Operations)

Bristol Myers Squibb
Devens - MA, United Statesfull_timeVerifiedPosted 31 Oct 2023

About the role

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.

Position: Associate Director, Manufacturing Technology (Process Technical Operations)

Location: Devens, MA

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

Position Summary

This position is the principal subject matter expert and process owner for the commercial manufacturing drug substance processes at Bristol Myers Squibb, Devens Biologics. This position provides technical leadership with respect to manufacturing support, investigations, impact assessments, change control management and process robustness initiatives. The successful candidate will have expertise in one or more areas of biologics manufacturing, and a proven track record of successful leadership of technical teams who achieve high results and exhibit a strong culture of excellence.

Reporting to the Director, Biologics Manufacturing Technology, the Associate Director, Process Technical Operations will provide technical oversight for Devens site commercial biologics manufacturing. The successful candidate will lead a dynamic and highly technical team of engineers and scientists by setting appropriate objectives and priorities, overcoming obstacles; and timely delivering results.

Key Responsibilities

• Highly advanced knowledge of the principles and concepts applicable to all aspects of commercial biologics drug substance manufacturing, data analytics and deviation / change management.

• Influences technical direction for biologics drug substance manufacturing across media/buffer, cell banking, cell culture, purification, formulation and fill through to freeze.

• Delivers a broad portfolio of complex projects within commercial manufacturing and makes decisions that consistently require developing new options to solve highly complex, sometimes novel problems.

• Accountable for technical aspects of site regulatory inspections with thorough understanding of regulatory environment and industry trends for biologics drug substance specifically in relation to drug substance manufacturing, investigations and facility control.

• Supports the BMS investigation program at the site. Supports the in-process investigations and/or directs process and other complex investigations (cross site where applicable).

• Holds technical accountability for specific aspects of the brand book of work for all commercial processes at Devens Biologics and drives accountability at these activities at the site.

• Thorough knowledge of quality systems, Quality by Design, validation principles for product and manufacturing processes, and process control fundamentals in commercial manufacturing.

• Established as a mentor within the department and developing as a role model that influences culture and values across teams by actively promoting scientific and operational excellence.

• Routinely liaising within the MS&T internal BMS network for technical and operational improvements and issue resolution.

• Comprehens

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Company

Bristol Myers Squibb

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