Director/Senior Director, Viral Vector Substance & Product Clinical Manufacturing

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

Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and BMS’s continued investment in our Cell Therapy capabilities, the growth potential of this science, your career, and the ability to help patients are incredible.

Position Summary

This position leads the Gene Delivery Clinical cGMP Manufacturing Team responsible for ensuring the robust internal vector supply for next generation CAR-T Assets. The individual will be part of the Gene Delivery Process and Analytical Development organization. He/she will establish interrelationships between process development, manufacturing, quality, and regulatory aspects of Gene delivery development and how it pertains to overall business strategy. He/she will apply that understanding to drive cross-functional improvements to support the successful design, qualification, and startup of clinical cGMP vector substance and vector product manufacturing operations at BMS. In addition, the individual will be a core member of the CMC teams for early-stage programs, leading efforts to ensure successful transfer and execution of vector substance and vector product supply. The individual will set the strategy and goals for the department and define priorities during execution.

The individual will oversee a team consisting of manufacturing operators, process engineering, technical support, and warehouse staff. He or She will also have experience with equipment selection, with support of qualification activities. BMS evolving Biologics/Gene- therapy portfolio fosters a high throughput, highly productive cGMP manufacturing operations fueling a fast-paced environment. This position offers an experienced individual a significant opportunity to establish best practices for operational leadership and technical support of cGMP manufacturing operations and drive the vision and strategy for this key BMS asset.

Responsibilities

• Lead an operational team of ~17 FTEs with direct managers overseeing Upstream, Downstream, Engineering, Technical Transfer and Warehouse Support functions
• Lead cross functional technology transfer teams for internal and cGMP manufacturing.
• Demonstrate ability to play the role of group leader, tech transfer team leader. Demonstrate ability to impact and influence the decisions of a team, external parties, and higher-level group.
• Identifies industry trends and provides guidance on how to maintain operational excellence. Identifies opportunities for technical innovation. Recognized as scientific leader in particular discipline.
  • Ensure cGMP batch documentation allow the process to achieve the intended process control strategy. Ensure that the process routinely achieves control limits and specifications
  • Informs personnel of communications, decisions, policies, and all matters that affect their performance, attitudes, and results.
  • Supports the validation of processes and preparation for commercialization.
  • Investigate, identify root cause, and identify CAPA for manufacturing deviations.
  • Trend process performance. Establish data analytics to serve as metrics, to assist in investigations, and as feedback to Process Development for scale up / process transfer.
  • Author technical reports and protocols in support of cGMP activities.
  • Coordinate sampling plans for GMP batches related to lot release, stability, and characterization.
  • Partner with Process Development to ensure successful process transfer.
  • Collaborate with Process Development on opportunities to improve process performance and cGMP operations.
  • Being a key driver of the interrelationships between process development, manufacturing, quality, and regulatory aspects of cGMP execution
  • Maintains working knowledge of current literature (i.e. literature, conferences, seminars). Can synthesize information from literature for novel applications process development and manufacturing.

Qualifications

• Biochemical engineer, Chemical engineer, or Biochemistry background. MS/BS with 15+ years’ experience in the pharmaceutical or biotechnology industry. Advanced degrees will also be considered.
• Demonstrated knowledge of cGMPs and experience providing technical support in a cGMP manufacturing environment.
• Experience in biologics, vaccines or viral vector process development or cGMP manufacturing.
• Demonstrated expertise in scale-up and process transfer for either cell culture/fermentation unit operations or protein/nucleic acid purification unit operations.
• Experience implementing biotechnology unit operations including fermentation, enzymatic reactions, chromatography, tangential flow filtration, and terminal filtration.
• Experience in single use bioprocessing technologies.
• Proven track record leading and managing cross functional teams.
• Knowledge of data management tools and statistical process control
• Experience writing and revising standard operating procedures and batch production records
• Experience with operating and troubleshooting process equipment
• Experience working on late phase and commercial programs is a plus

If you want to challenge yourself, accelerate your career, and give new hope to patients, there’s no better place than here with our Cell Therapy team. Full of incredible and dedicated team members, those working on CAR-T and other forms of Cell Therapy are transforming patients’ lives through science. From studying individualized cell lines to making brand new discoveries, this bold and personal discipline allows you to grow your career while making a lasting impact on the field of medicine. Join us today.

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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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