If you are an Associate Manager or Director - Drug Product, Technical Operations with 10+ years of professional experience working in cGMP parenterals or pre-filled syringe medical devices, please read on!
***This job is currently 100% remote***
Based in San Francisco, CA our client is a clinical-stage biopharmaceutical company that is focused on the development of novel therapeutic compounds to treat disease through the inhibition of the complement system, which is an integral component of the immune system, at the level of C3, the central protein in the complement cascade.
Due to continued company growth they are currently seeking an Associate Director of Drug Product Technical Operations to join there team. The ideal candidate will have experience with late stage drug development and CMC module authorship along with having prior accountability for the development and implementation of parenteral Drug Product at Contract Manufacturing Organizations.
If you have the above experience and you are currently open to exploring new opportunities, please read on!
What You Will Be Doing
Establishes and oversees process development strategy and timeline to ensure phase-appropriate manufacturing processes and procedures.
Participates in the active writing of CMC modules for clinical and commercial regulatory applications.
Actively manage development activities, ensuring close partnership through open and transparent communication, scientific and strategic understanding, and attention to priorities and details.
Accountable for leading teams to ensure process development, technology transfer, process validation, and device development are successful.
Ensure that all aspects of Drug Product CMC life cycle management are completed on time, within budget and meet highest scientific, regulatory, quality, and commercial standards.
Establish effective relationships with all development and manufacturing partners to provide oversight and coordinate with internal teams.
What You Need for this Position
- Degree in Life Sciences, Advanced Degree is highly Desired
- 10+ years of experience working of working in Drug Product Technical Operations leading all aspects of the Drug Product CMC Life Cycle
- Prior experience working in cGMP parenterals or pre-filled syringe medical devices
- Aseptic processing and sterile fill/finish experience
- Contract Manufacturing Organizations experience
- Excellent communication skills
What's In It for You
Competitive base salary, annual performance bonus, stock options, excellent benefit package which includes: health insurance with full premium coverage, 401K with company match, paid time off (PTO), long- term disability insurance, life insurance and more!
So if you are an Associate Manager or Director - Drug Product, Technical Operations with 10+ years of professional experience working in cGMP parenterals or pre-filled syringe medical devices, please apply today!
Applicants must be authorized to work in the U.S.
Email me to apply for this position