Principal Scientist, Sterile Drug Product Aseptic (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

#LI-Onsite

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 a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role:

Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

Supporting People with Disabilities

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 adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

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

If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/

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R1601233 : Principal Scientist, Sterile Drug Product Aseptic (Manufacturing, Science & Technology)