Assoc Dir, Drug Substance Manufacturing

SUMMARY/JOB PURPOSE:

This role is responsible for supporting Exelixis small molecule development and commercial pipeline for commercial and clinical needs. Is part of a team that leads the efforts at our contract manufacturing organizations (CMOs) to direct all aspects of our Drug Substance (DS) manufacturing including process improvement, verification and scale-up to support larger volume commercial production. This role contributes to technology transfers, process validation and commercial preparedness for manufacturing at contracted external sites.

Essential Duties And Responsibilities:

* 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 with the DS team to propose process improvements and/or scale up to processes where efficiencies can be introduced.
* Execute tech transfers, process qualification and validation at alternate manufacturing sites in preparation of commercial launch.
* Work with the DS team to develop phase appropriate GMP processes for development products at our CMOs.
* 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.
* Assist with expanding the DS team to support commercial manufacturing and tech transfer for Drug Substances at our external manufacturing organizations.
* Act as a technical subject matter expert (SME) internally for troubleshooting and other internal assessments.

Supervisory Responsibilities:

* Supervise staff, including hiring, scheduling and assigning work, reviewing performance, and recommend salary increases, promotions, transfers, demotions, or terminations.
* Direct work of a CMO, Consultant or 3 rd party

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

* BS/BA degree in related discipline and a minimum of 11 years of related experience; or,
* MS/MA degree in related discipline and a minimum of 9 of related experience; or,
* PhD in related discipline and a minimum of 5 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:

* Experience working with CMOs in a manufacturing role. Track record of working with external contract organizations and thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing.
* Experience in Biotech/Pharmaceutical industry, especially in process engineering, is preferred.
* Experience in performing technology transfer of processes.
* Experience in interacting with external CMOs.
* Experience in process development, process characterization, process validation.
* Experience working with contract manufacturing organizations (CMOs) in North America, EU and Asia, including raw materials and Drug Substances is also highly desired.

Knowledge/Skills:

* Knowledge in P.A.T and Pharmaceutical Quality by Design principles is a plus.
* Knowledge of regulatory and compliance issues as they pertain to the global development and commercialization of Drug Substances.
* Strong process engineering experience is preferred.
* CDMO management and oversight is a must.
* Exposure and understanding of cGMP, quality and regulatory requirements. Preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs) may be required.
* Good technical knowledge in raw materials and drug substance manufacturing.
* Small molecule experience required.
* 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. Some experience and skills in authoring regulatory submissions is a recommended.

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If you like wild growth and working with happy, enthusiastic over-achievers, you'll enjoy your career with us!

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

We are an Equal Opportunity Employer and do not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state or local protected class.