What are the responsibilities and job description for the Senior Director, Global MS&T Sterile and Biopharmaceutical Products position at Jobleads-US?
Senior Director, Global MS&T Sterile and Biopharmaceutical Products
We are on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. We work with the world's leading manufacturer of generic medicines and the proud producer of many of the products on the World Health Organization's Essential Medicines List.
About the Role
- Support process development, optimization, and scale-up of sterile and biologics manufacturing processes.
- Work collaboratively with internal teams to design robust manufacturing systems, ensuring they meet performance, scalability, and quality standards.
- Implement process improvements, new technologies, and innovations in the sterile and biopharmaceutical production lines.
Regulatory Compliance and Risk Management
- Ensure manufacturing processes meet all regulatory requirements (FDA, EMA, ICH, GMP, etc.)
- Conduct risk assessments for sterile and biologic product manufacturing and implement mitigation strategies.
- Support preparation of technical reports and documentation to support regulatory filings and inspections.
Key Responsibilities
- Oversee the technical transfer of manufacturing processes from R&D to commercial scale.
- Develop and maintain best practices for the transfer of sterile and biologic processes to different global locations.
- Collaborate with cross-functional teams, including R&D, Quality, Regulatory, and Supply Chain, to ensure timely and compliant commercialization of products.
Requirements
- Bachelors Degree is required.
- D. in Chemical Engineering, Biochemical Engineering, Pharmaceutical Sciences, or a related field is preferred.
- Prior experience in managing or overseeing technology transfers across regional manufacturing sites is required.
Desirable Skills
- Proven expertise in biopharmaceutical manufacturing processes such as cell culture, fermentation, purification, sterile fill-finish, and packaging.
- Familiarity with modern technologies such as single-use systems, automation, and continuous processing.
- Advanced understanding of regulatory requirements and industry guidelines (FDA, EMA, ICH, GMP).
What We Offer
- Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls.
- Retirement Savings: 401(k) with employer match, up to 6% and an annual 3.Time Off: Paid Time Off including vacation, sick/safe time, caretaker time and holidays.
- Life and Disability Protection: Company paid Life and Disability insurance.
