Senior Manager, CMCCMC - Manufacturing - Bay Area
i-Pharm Consulting is currently working with a leading biotech who are developing novel therapeutics in the rare disease space.
They have recently received new funding and are looking to build out their CMC team. This role will be responsible for managing CMC-related manufacturing activities and execution of the plan for drug substances and drug products from clinical through commercial development.
Key Responsibilties in this role will be as follows;
- Follow and execute the company's CMC development plan for drug substances and drug products from pre-clinical through commercial development.
- Manage and work with external manufacturers / vendors in unison with the Quality and Regulatory teams.
- Assist in identifying contract manufacturing and analytical laboratory sites required to guide and support third party manufacturing relationships.
- Oversee contract manufacturing, testing, packaging and labeling operations for the company's drug substances and drug products. Act as primary liaison with contractor(s) on assigned projects. Guide external operations through tech transfer, process and method development, optimization, qualification and validation of the activities related to all manufacturing operations.
The successful candidates will have a minimum of 7 years' experience. Experience must include small molecules in a pharmaceutical or biotechnology environment. They will also have a background in outsourced drug substance clinical development through commercialization
Lastly, experience in managing US CRO/CMO for the manufacture of cGMP drug substances and drug products; experience collaborating with international CROs, CMOs, a plus.
This business is a culture first environment so you must be willing to work in a small well funded who have a friendly culture and are highly collaborative. You must be dynamic and enjoy a good laugh!
The role is a hybrid role working two days per week in the office. Tuesday and Wednesday, typically.
If you think you are a good fit for this role, please click Apply!