Bristol Myers Squibb Director, Aseptic & Microbial Process Control Sciences in Devens, Massachusetts
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.
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This individual is accountable to harmonize and elevate aseptic processing and microbial control strategies and technologies for BMS’s sterile drug product & biologics drug substance internal and external manufacturing network. The Director of Aseptic & Microbial Process Control Sciences responsibilities include: (1) Leading a team of SMEs responsible for harmonizing standards for holistic microbial control at DP & DS internal and external manufacturing sites (2) Resolving emerging microbial control issues and trends in manufacturing, and (3) Creating a global Aseptic Processing governance structure within the existing BMS infrastructure.
The Director of Aseptic & Microbial Process Control Sciences will be part of the Manufacturing Sciences & Technology team and will be recognized as a subject matter expert in the principles and application of aseptic processing and microbial control strategies and technologies in a GMP manufacturing environment, with advanced knowledge of global Health Authority regulations. This position will report into the Senior Director of Global Capabilities & Technical Strategy, MS&T and can be based in Devens, MA or New Brunswick, NJ.
This role will partner with stakeholders and manufacturing sites to define contamination control strategies and provide guidance to site programs such as: environmental monitoring, media fill programs, operator training & gowning, utility qualification, cleaning & disinfection, and sterilization programs. The individual will interface with internal and external manufacturing sites to ensure that the control strategies comply with industry guidance and to support the establishment and maintenance of critical cGMP aseptic activities. The incumbent will also support significant manufacturing investigations involving aseptic processing and microbial events. This role will closely collaborate with the MS&T Biologics Parenteral and Drug Substance teams, manufacturing sites, as well as the Microbiology CoE within the development group. It is expected that this role will also engage with industry forums such as PDA, BPOG, and ISPE.
6 – 8 direct reports
Business Partners & Interactions
The Aseptic Processing SME influences and maintains effective collaborations across the BMS network, closely partnering with MS&T Parenteral, MS&T DS, CMC Regulatory, Quality, QC, Manufacturing sites, Development, Microbiology CoE, as well as other partner functions.
This role will interact with Health Authorities.
Provide oversight and technical guidance to manufacturing site contamination control strategies and processes, including: environmental monitoring, media fill program design, smoke studies, sterilization programs, facility & utility qualification, cleaning & disinfection programs, operator training and gowning, and intervention strategies.
Lead a team of 6-8 microbiology & aseptic SME scientists located globally.
Lead and guide sites (internal and external) on existing & emerging regulations related to sterile manufacturing (i.e.: Annex 1)
Support the design and implementation of risk-based approaches and strategies designed to control and prevent contaminations in DS & DP manufacturing processes.
Lead / support critical manufacturing investigations related to aseptic control and contamination events, including root cause analysis, risk assessments, and product quality impact assessments. Design and implement corrective and preventative actions to prevent future manufacturing disruptions.
Support Technical Transfer activities, harmonize global approach to microbial in-process control strategies, microbial sampling plans, and microbial limits and control strategies for raw materials.
Support regulatory submissions, author and review relevant sections related to microbial and aseptic control and sterilization validation.
Support agency queries & IRs, and agency inspections related to aseptic and microbial process control.
Provide oversight to aseptic processing validation master plans and qualification activities.
Interface with industry consortiums such as BPOG, ISPE, PDA to maintain a view of the current trends and best practices for aseptic processing & microbial control strategies.
Collaborate with Biologics Process Development, Engineering, Sterile Product Development, Clinical Supply Manufacturing and Commercial Sites on new aseptic processing technologies, equipment and platforms.
Implement improvements to performance monitoring programs and continuous improvement initiatives.
Influence across the network to gain alignment with key stakeholders on implementation of best practices and new aseptic processing methodologies
- Bachelor’s degree or equivalent in relevant engineering or scientific discipline with a minimum of 16 years of relevant experience. Masters or PhD is preferred (but not required). Time spent in advanced degree programs may be considered as equivalent relevant experience.
Experience / Knowledge Desired:
Subject matter expert in sterile manufacturing and biologics processes and technologies, and aseptic processing techniques.
Demonstrated ability to implement industry recognized best practices for sterility assurance and contamination control.
Intimate knowledge of global regulatory requirements related to the design and control of aseptic processes.
Solid understanding of commercial biologics GMP DS & DP manufacturing operations.
Experience with leading environmental monitoring programs, facility/utilities qualification, gowning practices, media fill programs, smoke studies, sterilization practices and aseptic techniques.
Working knowledge of microbiological testing including environmental monitoring, bioburden, bacterial endotoxin, sterility, microorganism identification, and various laboratory equipment, instrumentation, and techniques is a plus.
Demonstrated strong oral and written communication skills, and stakeholder management skills.
Familiarity with Design of Experiments, Quality by Design, and Risk Assessment concepts commonly employed in pharmaceutical process development.
Experience in leading complex investigations and root cause analysis, utilizing risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.
Demonstrated ability to influence areas not under direct control to achieve objectives, and work well in a matrix environment
Requires approximately 25% travel.
Personal Competencies Desired/Required:
Strong strategic and analytical thinking, problem solving and rapid decision making skills
Demonstrates an enterprise mindset, understands the big picture and possesses high business acumen.
Ability to lead within the broader internal and external network, and seeks to have impact on organization-wide performance
Demonstrated capability in implementing challenging goals, objectives and practices in a complex global environment
Strong ability in negotiating and influencing in complex, high impact situations
BMS Bio-Pharma Behaviors Required:
Accountability: We all own BMS’ success and strive to be transparent and deliver on our commitments
Urgency: We move together with speed and quality because patients are waiting
Innovation: We pursue disruptive and bold solutions for patients
Passion: Our dedication to learning and excellence helps us to deliver exceptional results
Integrity: We demonstrate ethics, integrity and quality in everything we do for patients, customers and colleagues
Inclusion: We embrace diversity and foster an environment where we can all work together at our full potential
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.
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.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to firstname.lastname@example.org . Visit careers.bms.com/ (https://careers.bms.com/eeo-accessibility) eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
Company: Bristol Myers Squibb
Req Number: R1568410
Updated: 2023-05-28 02:30:17.032 UTC
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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