Executive Director, Sterile Drug Product, MS&T

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Bristol Myers Squibb is seeking a key leader in our Manufacturing Sciences & Technology organization. The Executive Director, Sterile Drug Product, Manufacturing Sciences & Technology is responsible for scientific and technical oversight of Sterile drug product (small and large molecule) manufacturing processes from validation at initial commercialization through life cycle management, at BMS' internal and external manufacturing network. This position reports to the Vice President of MS&T, within BMS' Global Product Development and Supply Division.

The role connects Process Development and Commercial Manufacturing Operations to ensure rapid commercialization of robust, compliant processes and effective lifecycle management. With direct accountability for teams of scientists and engineers on two internal sites, as well as global external manufacturing support locations, the role is a critical enabler of our pipeline success.

The leader of Sterile Drug Product Manufacturing Sciences & Technology is responsible for scientific and technical oversight of manufacturing processes from full scale process validation through commercialization and life cycle management for BMS' internal and external global network for biologics drug substance. This MS&T leader will also work in close collaboration with Sterile Drug product Process Development teams and Manufacturing sites in Manati, Puerto Rico and Phoenix, Arizona, in addition to a network of external manufacturers. The person has direct responsibility for a team of approximately 130 scientists and engineers to support a growing product portfolio, and all Manufacturing Technology teams in plants will report to this position.

In collaboration with Biologics Process Development, the jobholder is responsible for commercial process design, scaleup and technology transfer. The role also ensures effective development of process control strategies and specifications for manufacturing during commercialization at scale. In addition, the jobholder will lead the lifecycle management of the drug product processes for all approved sterile products and will be the lead technical representative to global regulatory agencies for these products.

Key responsibilities:

• Successful, efficient tech transfer and process validation at scale from protocol design through execution across the biologics drug substance manufacturing network

• CMC authoring activities for DP manufacturing

• Data management and process monitoring activities to ensure appropriate Process Robustness and yields

• Identification and implementation of commercial process and life cycle improvements, including evaluation and implementation of innovative technologies to improve process control or efficiency.

• Develop and implement innovative solutions to process analysis and control throughout the lifecycle

• Attract, lead, and develop a world-class team of scientists and engineers

This position can be located in Devens, MA, New Brunswick, NJ, Dublin, Ireland or Boudry, Switzerland.

Qualifications:

• Bachelor's degree in pharmaceutical or related sciences (Masters or Ph.D. strongly preferred) with at least 15 years of experience in pharmaceutical manufacturing and a solid record of achievement in roles of increasing responsibility.

• In-depth knowledge and understanding of parenteral drug development process, and CMC related FDA and international regulations. Able to anticipate industry trends and emerging issues.

• Demonstrated ability to develop and execute organizational/business strategy to bring maximum value to the organization

• Demonstrated ability to effectively develop and lead high performing global organizations of industry leading and highly talented experts

• Experiencing of developing and implementing strategy to optimize processes and proactively manage risk

• Strong strategic awareness and an ability to successfully navigate complex, matrix organizations

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If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.

COVID-19 Information
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

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