Director, Biologics Analytical Development - Alameda, CA

Only for registered members Alameda, CA, United States

1 month ago

Job summary

The Director leads a team responsible for analytical activities at external contract development and manufacturing organization (CDMO) sites to support the development and manufacturing of biological drug candidates. The incumbent utilizes technical expertise to advance CMC development and manufacturing for pre-IND and in-clinic biological molecules.
The Director owns one or more projects with hands-on responsibility as the analytical point of contact in interactions with CDMO/CTL. They take ultimate accountability for setting up phase-appropriate analytical programs per project timelines.
This includes method development, qualification, validation, reference standard qualification, stability setup specification analysis comparability product characterization etc..
The Director provides analytical support to process development on process activities at CDMO sites builds processes seamless handover routine GMP testing batch release review QC operation teams after set up CTL aligned change control deviation investigation activities.
This position requires demonstrated experience managing CDMO/CTL clinical commercial biological products extensive outsourcing method transfer qualification product characterization stability cGMP initiation activities IND projects broad knowledge biologics analytic program phrase appropriate strategies ability collaborate lead cross functionally multi task fast paced dynamic environment deliver high quality work strong understanding cGMP regulations.

Job description

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