Director/Sr. Director, Manufacturing - Job # 07-016

Oversees all aspects of Ceregene's manufacturing processes.
Participates in planning the overall manufacturing strategy for product
development for drugs and delivery devices, ensuring alignment with
overall business strategy. Manages a team of five manufacturing and
process development professionals in the planning and execution of
manufacturing for advanced clinical trials. Manages the selection,
contract, coordination with and performance of external CMO's. Plans
and directs the technology transfer of products from research and
development to international or domestic CMOs including process limits
studies and process validation studies. Participates in regulatory
strategy and planning, managing the CMC regulatory submission process.

Requirements include a degree (prefer Master's or Ph.D.) in a
biological, chemical or biotechnology engineering or related discipline
and 8 + years management experience in a cGMP pharmaceutical
manufacturing environment with small and large scale cell culture,
fermentation and/or purification and medical devices. Must have
regulatory knowledge and experience dealing with regulatory agencies
(FDA). Must have experience with CMO selection, contract negotiation,
and management. Good leadership and people management skills, sound
judgment, exceptional organizational and project management skills, and
ability to multi-task and thrive in a fast-paced entrepreneurial
environment. Flexibility and a positive, "can-do" attitude are
necessary.