Principal Scientist, Sterile Drug Product Aseptic (Manufacturing, Science & Technology) Full-time NEW

Sterile Drug Product Aseptic Process Principal Scientist (Manufacturing, Science & Technology)

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Position: Sterile Drug Product Aseptic Process Principal Scientist (Manufacturing, Science & Technology)

Location: Cruiserath, Ireland

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.

· A minimum of 10 years' experience within a Sterile Drug Product Manufacturing, with a minimum of 5 years 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