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

The Principal Scientist, Sterile Drug Product Aseptic will provide sterility oversight to ensure Quality & Regulatory Compliance for the aseptically manufactured products, processes & systems occurs in accordance with Regulations and BMS requirements.

Requirements

• 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.

Benefits

• annual bonus
• pension contribution
• family medical allowance
• 27 days of annual leave
• life assurance
• on-site gym