Position Summary
The incumbent will provide sterility oversight to ensure aseptic filling processes and Quality & Regulatory Compliance for aseptically manufactured products, processes, and systems are performed in accordance with regulations and BMS requirements. As part of the role, the principal scientist will lead 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 facility.
Technical support of contamination control strategy, risk assessments, smoke studies, environmental monitoring trend analyses, aseptic training, and qualification programs.
Participates in health authority inspections (HPRA, EMEA, FDA, and international authorities) including managing requests and responses, providing updates, and ensuring adherence to regulatory commitments.
Active role owner in audit preparation for the site, assisting in the generation of responses and owning sterility assurance CAPAs and media fills.
Supports field alerts reports (FAR) and biologic product deviation reports (BPDR) as needed.
Provides input on deviations regarding 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.
Assures that sterility compliance is maintained by fostering a high commitment to quality and compliance while working proactively with stakeholders.
Ensures budget development and prepares periodic projections of spending against budgets for the assigned activities.
Anticipates and actively monitors regulatory trends and best practices, implementing them at the site as applicable using a simplistic and innovative approach.
Ensures site cGMP procedures are aligned and compliant with BMS corporate compliance, policies, and directives.
Travel approximately 10% to regional headquarters or other business travel as required.
Qualifications & Experience
BS in Life Sciences (Microbiology, Pharmacy, Biology, or related pharmaceutical sciences). Master’s degree preferred.
Minimum of 10 years’ experience in sterile drug product manufacturing, with at least 5 years experience with media fills / aseptic process simulations.
Extensive knowledge of sterility assurance, microbiology, environmental monitoring, aseptic manufacturing, quality control testing, and federal/international regulations.
Proficiency in cGMP, FDA, and EMA regulations and requirements.
Experience in contamination control strategy and quality risk management concepts.
Proven record of delivering results and action orientation.
Embraces complexity while striving for simplicity.
Excellent communication and interpersonal skills, able to interface with a broad range of stakeholders at all organizational levels.
Effectively manages cultural and operational differences.
Working knowledge of PCs 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.
Equal Employment Opportunity Statement
We are an equal opportunity employer. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
#J-18808-Ljbffr