SUMMARY/JOB PURPOSE:

This role is responsible for supporting Exelixis' small molecule development from early-stage development through commercialization. This role is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) development and manufacturing. Specifically, s/he guides our CMO partners in process development/optimization, process verification and scale-up to support larger volume development and commercial production. This role leads projects, technology transfers, process validation, and commercial preparedness for manufacturing at contracted external sites.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Propose process improvements for scale up to processes where efficiencies can be introduced.

• Develop phase appropriate processes for development products at our CMOs.

• Execute tech transfers, process qualification and validation at manufacturing sites.

• Work with our CMOs to ensure that the productions of our materials are executed on time, and successfully per our technical, quality, and regulatory requirements.

• Review and approve batch documents for drug substance manufacturing ensuring they meet the technical and regulatory requirements.

• Closely track and monitor manufacturing performance including deviations, batch record comments, data trending, and batch yields.

• Work closely with other team members within the department and other functional areas/departments, including logistics and planning functions to ensure Drug Substance and Raw Materials production is part of a robust supply chain.

• Contribute to regulatory submissions by writing, reviewing, appropriate sections.

• Preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs) may be required.

• Act as a technical subject matter expert (SME) internally for troubleshooting and other internal assessments.

SUPERVISORY RESPONSIBILITIES:

• No supervisory responsibilities initially.

• Direct work to CMOs, Consultant, and/or 3rd party.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in related discipline and a minimum of eleven years of related experience; or,

• MS/MA degree in related discipline and a minimum of nine years of related experience; or,

• PhD in related discipline and and a minimum of five years of related experience; or,

• Equivalent combination of education and experience.

• May require certification in assigned area.

Experience/The Ideal for Successful Entry into Job:

• Proven organic chemistry skills with experience in process optimization, development and commercial manufacturing. Small molecule experience required.

• Experience in Biotech/Pharmaceutical industry, especially in process chemistry, is preferred.

• Experience in performing technology transfer of processes.

• Experience in development of drug linker molecules for ADCs and PDCs is a plus and highly desired.

• Experience in working with contract manufacturing organizations (CMOs) in North America, EU, and Asia, including raw materials and Drug Substances.

• Some process engineering experience is preferred.

• Some experience and skills in authoring regulatory submissions is a recommended.

Knowledge/Skills:

• Exposure and understanding of cGMP, quality, and regulatory requirements.

• Knowledge of regulatory and compliance issues as they pertain to the global development and commercialization of Drug Substances.

• Good technical knowledge in small molecular drug substance manufacturing.

• Knowledge in P.A.T and Pharmaceutical Quality by Design principles is a plus.

• Strong and effective interpersonal skills, a fast-paced company.

• Team player with high integrity and creativity.

• Ability to communicate clearly and concisely verbally and in writing.

WORKING CONDITIONS:

• Environment: primarily working indoors in an office/lab environment or meeting with clients

• Travel required - 30% of domestic travel required

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