Associate Director Biologics External Manufacturing
- Location: San Diego, REMOTE
- Competitive and Comprehensive Compensation Package
This Associate Director will have the following Responsibilities:
- Manage third party manufacturers for activities related to commercial and clinical manufacturing.
- Act as company liaison for CDMOs and regulatory agencies.
- Help establish strong capability for manufacturing processes and associated work This includes the manufacturing of drug substance composed of proteins and combinations of proteins with and without small molecules
- Lead CMC activities within cross functional teams for all activities related to new product development
- Regular leadership functions: hiring, training, with large focus on management of the career development and technical expertise of staff to ensure individual and company growth.
- Collaborate with senior leadership within CMC to help shape goals and strategic vision for the CMC organization.
The Ideal Candidate will have the following skill set:
- Open to any degree level within a scientific or engineering field with accompanying level of experience in industry.
- Expertise in drug development through full lifecycle - preclinical through Phase 3 and registration.
- Experience in development and transfer of production processes for biologics and/or recombinant proteins.
- Background working in cross functional environments and partnering with quality, regulatory affairs, MSAT, Operations Strategy, and R&D,
- Experience managing external agencies like CDMOs and suppliers. Previous leadership experience required.