Regulatory Cmc Jobs in California

Provides clear directions, delegates appropriately, communicate proactively, providing both project and people management skills.

Broadly skilled drug development scientist with evidence of strategic, tactical and operational abilities.

15+ years experience, in biologics drug development and manufacture

Knowledge of cGMP regulations, ICH guidelines, and the CMC content of global regulatory submissions

Substantial biotech/industry drug development experience is necessary, a track record leading process development and product supply activities for biologics.

Experience developing combination products such as autoinjector devices is desired.

Lead and manage multiple and concurrent drug substance projects, with responsibilities including:

Excellent written and oral communication skills, including experience in technical writing in support of regulatory submissions.

Good organizational skills and the ability to manage multiple competing priorities.

Lead and manage formulation development, which may entail one or more of

Experience working, collaborating with, and managing CDMOs.

Good knowledge of formulation options and troubleshooting

Strong sense of planning and prioritization, and the ability to work with all levels of management.

Ensure that CMC content is complete, well-written, and meets all relevant requirements.

Manage regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP/quality investigations throughout development.

Biologics experience required; cell or gene therapy experience strongly preferred. Medical device experience also preferred.

Excellent interpersonal skills to communicate difficult concepts and persuade others.

Strategic thinking and strong problem-solving skills with outstanding attention to detail.

Minimum of fifteen years’ experience in a senior management level role in CMC, with increasing responsibilities.

Play a key role in developing and implementing integrated CMC regulatory strategies for AnaptysBio’s pipeline projects.

B.S is required, PhD preferred.

Position may require occasional evening and/or weekend commitment

Position may require domestic and international travel