Principle Scientist, Sterile Drug Product Aseptic Process

at  BristolMyers Squibb

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

The incumbent will provide sterility oversight to ensure of the aseptic filling process and Quality & Regulatory Compliance for the aseptically manufactured products, processes & systems occurs in accordance with Regulations and BMS requirements. As part of the role, she/he will be leading the team to qualify the Media Fill (Aseptic Process Simulations) in the new Sterile Drug Product facility on site reporting directly to the Senior Director SDP MS&T.
This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.

Key Responsibilities

• Program owner for all media fill activities associated with the new Sterile Drug Product facility.
• Leading and coaching team to execute and deliver Media Fills within the new Sterile Drug Product facility.
• Technical support of Contamination Control Strategy, Contamination Control Risk Assessments, Smoke Studies, Environmental Monitoring Trend Analyses, Aseptic Training, and Qualification programs within the new Sterile Drug Product facility.
• Participates in Health Authority inspections (HPRA, EMEA, FDA, and International Authorities) which includes managing the requests and responses, providing updates, and adherence to the regulatory commitments.
• Active role owner in various audit preparation for the site, including the assistance in the generation of responses and owning the Sterility Assurance relevant CAPAs and Media Fills.
• Supports the Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR) as needed.
• Provides input, where required, for all deviations with respect to the Sterility Assurance and the Aseptic Manufacturing Process.
• Works closely on resolution of critical Sterility Assurance issues that can impact supply continuity of critical medication to patients.
• Assure that the sterility compliance state of control is maintained by creating and sustaining a high commitment to quality and compliance and works proactively with the different Quality and Operations stakeholders.
• Ensures budgets development and the preparation of periodic projections of spending against budgets for the assigned activities.
• Anticipates and actively monitors regulatory trends and best practices in the industry and implements at the site as applicable using simplistic and innovative approach.
• Ensure site cGMP required procedures are in alignment and compliance with BMS Corporate Compliance and Headquarters Polices and Directives.
• This position requires approximately 10% travel to regional headquarters, or any other business travels as assigned.

Qualifications & Experience

• BS in Life Sciences (Microbiology, Pharmacy, Biology, or a related pharmaceutical sciences). Master’s degree preferred.
• Extensive experience within a Sterile Drug Product Manufacturing and experience with Media Fills / Aseptic Process Simulations is essential.
• Extensive knowledge and experience in Sterility Assurance, Microbiology, Environmental Monitoring, Aseptic Manufacturing, quality control testing and federal/International regulations are essential for appropriate decision-making ability and representation to regulatory agencies.
• Proficient in cGMP’s and FDA and EMA regulations and requirements.
• Experience in Contamination Control Strategy and Quality Risk Management concepts.
• Has a proven record of accomplishment of delivering results and is action oriented.
• Embraces complexity but strives for simplicity.
• Excellent communication and interpersonal skills, with the ability to interface with a broad range of internal and external stakeholders at all levels of the organization.
• Effectively manage cultural and operational differences.
• Working knowledge in PC’s and electronic tools.

Why you should apply

• You will help patients in their fight against serious diseases
• You will be part of a company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
• You’ll get a competitive salary and a great benefits package including an annual bonus, pension contribution, family medical allowance, 27 days of annual leave, life assurance and on-site gym

• Program owner for all media fill activities associated with the new Sterile Drug Product facility.
• Leading and coaching team to execute and deliver Media Fills within the new Sterile Drug Product facility.
• Technical support of Contamination Control Strategy, Contamination Control Risk Assessments, Smoke Studies, Environmental Monitoring Trend Analyses, Aseptic Training, and Qualification programs within the new Sterile Drug Product facility.
• Participates in Health Authority inspections (HPRA, EMEA, FDA, and International Authorities) which includes managing the requests and responses, providing updates, and adherence to the regulatory commitments.
• Active role owner in various audit preparation for the site, including the assistance in the generation of responses and owning the Sterility Assurance relevant CAPAs and Media Fills.
• Supports the Field Alerts reports (FAR) and Biologic Product Deviation Reports (BPDR) as needed.
• Provides input, where required, for all deviations with respect to the Sterility Assurance and the Aseptic Manufacturing Process.
• Works closely on resolution of critical Sterility Assurance issues that can impact supply continuity of critical medication to patients.
• Assure that the sterility compliance state of control is maintained by creating and sustaining a high commitment to quality and compliance and works proactively with the different Quality and Operations stakeholders.
• Ensures budgets development and the preparation of periodic projections of spending against budgets for the assigned activities.
• Anticipates and actively monitors regulatory trends and best practices in the industry and implements at the site as applicable using simplistic and innovative approach.
• Ensure site cGMP required procedures are in alignment and compliance with BMS Corporate Compliance and Headquarters Polices and Directives.
• This position requires approximately 10% travel to regional headquarters, or any other business travels as assigned