What are the responsibilities and job description for the Director, Drug Substance Manufacturing position at Exelixis?
Every Exelixis employee is united in an ambitious cause: to launch innovative medicines that give patients and their families hope for the future. In this pursuit, we know our employees are our most valuable asset. After operating in the challenging biotech sector for 25 years, we have a proven track record of resiliency in the face of adversity. The success of our lead product has provided a solid commercial foundation allowing us to reinvigorate our research efforts, and grow our team in areas such as Drug Discovery, Clinical Development and Commercial.
As we expand our global partnerships and further reinvest in R&D to help us discover the next breakthrough for difficult-to-treat cancers, we’re seeking to add talented, dedicated employees to power our mission.
Cancer is our cause. Make it yours, too.
This position will have a leading role in overseeing Exelixis Drug Substance contract manufacturers for commercial and clinical manufacturing of Exelixis compounds. The successful candidate will show provide technical expertise and leadership to the efforts to oversee development and manufacturing activities at our CMOs. This comprises all aspects of our Drug Substance manufacturing including process improvement, process verification and scale-up to support larger volume commercial production. This role will also be responsible for the execution of technology transfer, process validation and commercial preparedness for manufacturing at alternate supplier contract manufacturing sites.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- The individual will have advanced pharmaceutical organic chemistry skills, combined with experience managing contract manufacturing organizations (CMOs) in North America, EU and Asia, including raw materials and Drug Substances.
- Partner with our CMOs directly and exercise diligent and thorough oversight of our CMOs to ensure that the production of our materials is 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.
- Propose process improvements and/or scale up to processes where efficiencies can be introduced.
- Oversee tech transfer, process qualification and validation at alternate manufacturing sites in preparation of commercial launch.
- Provide leadership and technical knowledge for new compound development and subsequent supporting activities at CMOs.
- Develop phase appropriate GMP processes for development products at our CMOs.
- Work closely with other team members within the PSC department including logistics and planning functions to ensure Drug Substance and Raw Materials production is part of a robust supply chain.
- Identify and add additional sources for starting materials and intermediates, and develop plans for consistent and continuous supply.
- Represent process chemistry at department meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program.
- Support regulatory submissions by writing, reviewing, and approving specific sections.
- Act as the technical subject matter expert (SME) internally for troubleshooting and other internal assessments
- Supervises staff, including hiring, scheduling and assigning work, reviewing performance, and
- Directing work (no direct reports, but directing work to a CMO, Consultant or 3rd party.)
Education:
- Bachelor’s degree in related discipline and a minimum of thirteen years of related experience; or
- Master’s degree in related discipline and a minimum of eleven ears of related experience; or
- PhD degree in related discipline and a minimum of eight years of related experience; or
- Equivalent combination of education and experience.
- 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 is required.
- Progressively increased responsibility for chemical and pharmaceutical scale-up, technology transfer and manufacturing experience
- Small molecule experience required
- Experience in Biotech/Pharmaceutical industry preferred.
- Demonstrated experience in performing technology transfer of processes from one CMO to another.
- Experience managing manufacturing either internally or through an external CMO.
- Experience in process development, process characterization, process validation, P.A.T and Pharmaceutical Quality by Design principles.
- Comprehensive knowledge of regulatory and compliance issues as they pertain to the global development and commercialization of Drug Substances.
- Thorough understanding of cGMP, quality and regulatory requirements, including the preparation and writing of key sections of regulatory documents (such as NDAs, MAAs and INDs).
- Exceptional project leadership, organization, and communication skills.
- Must have good technical knowledge in raw materials and drug substance manufacturing with a good track record.
- Strong and effective interpersonal and leadership skills, a fast-paced company. Team player with high integrity, passion, courage, and ingenuity.
- Ability to communicate clearly and concisely verbally and in writing and has demonstrated strong experience and skills in authoring regulatory submissions.
- Environment: primarily working indoors, performing clerical work
- Travel required – 30% travel to CMO’s
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Additional Information
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.