SUMMARY/JOB PURPOSE:

This role is responsible for supporting Exelixis’ small molecule drug substance commercial and clinical manufacturing pipeline. You will be part of a team that oversees the technical and operational performance of our DS processes at our CMOs as principal point of contact. 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.  Specifically, the role guides and oversees our CMO partners in process changes/optimizations, process qualifications, process validations and commercial production. This role also leads change projects, raw materials qualifications, internal investigations, deviations support, technology transfers, scale-up as needed, and supports the transition of projects from development to commercial.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Support Exelixis’ Active Pharmaceutical Ingredient (API) and raw materials third-party manufacturers and test labs for Exelixis commercial drug substance ensuring strong technical oversight.
• As point of contact oversee, track, and manage active pharmaceutical ingredient (API) and raw material third-party manufacturers and test labs for Exelixis commercial drug substance to ensure adherence to Exelixis requirements.
• Lead onboarding and qualification of new raw materials suppliers.
• Lead and plan business review meetings with the CMOs tracking the manufacturing and quality performance of our products at the CMO
• Work closely and hands-on with our CMOs to ensure that the production of our materials is executed on time, and successfully per our technical, quality, and regulatory requirements.
• Work closely with other team members within the department and other functional areas/departments, including logistics, legal, QA, finance, and planning functions to ensure Drug Substance and Raw Materials production is part of a robust supply chain.
• Partner effectively with the quality organization to provide third-party oversight of commercial API manufacturing operations to deliver API that meets cGMP quality and compliance standards.
• Responsible for the timely review and approval of batch documents for drug substance manufacturing ensuring they meet the technical and regulatory requirements.
• Responsible for the tracking and monitoring of manufacturing performance including deviations, batch record comments, data trending, and batch yields.
• Perform full executed batch record review for intermediate and API batches as part of the disposition process to support Exelixis batch disposition targets.
• Enable process validation through reviews and approvals of process validation protocols, cleaning validation protocols, master batch records, and change controls, in close coordination with cross-functional team members from PSC Analytical and GMP QA
• Work with the DS team to propose process improvements and/or scale up to processes where efficiencies can be introduced.
• Approve all change controls using sound scientific understanding and in collaboration with key stakeholders.
• Plan, prepare content and facilitate business review meetings between Exelixis and CMOs
• Contribute to regulatory submissions by writing and reviewing the 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:

• The role has no direct supervisory responsibilities; however, the candidate is expected to provide direction to CMOs, consultants, or 3 rd parties.

EDUCATION/EXPERIENCE/KNOWLEDGE & SKILLS:

Education/Experience:

• BS/BA degree in organic chemistry, chemical engineering, or related discipline and a minimum of nine years of related experience; or,
• MS/MA degree in a related discipline and a minimum of seven years of related experience; or,
• Ph.D. in related discipline and a minimum of two 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:

• A minimum of twelve years of experience in a cGMP pharmaceutical/biotech manufacturing environment
• A minimum of eight years of experience in commercial small molecule active pharmaceutical ingredients manufacturing operations
• A minimum of two years of experience managing Contract Manufacturing Organizations preferred
• Track record of working with external contract organizations (CMOs) in a manufacturing role and a thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing is a must.
• Experience in working with contract manufacturing organizations (CMOs) in North America, EU, and Asia, including raw materials and Drug Substances is also highly desired.
• The successful individual will have proven organic chemistry or chemical engineering skills with demonstrated expertise in process optimization, troubleshooting, change, and deviation management.
• Experience in performing technology transfer of processes.
• Experience in process development, process characterization, and process validation.

Knowledge/Skills:

• Strong Knowledge of regulatory and compliance issues as they pertain to the commercial manufacture of Drug Substances.
• Good technical knowledge in raw materials and drug substance manufacturing.
• Excellent data analysis skills and experience with a variety of scientific software applications.
• Strong communication skills, excellent work ethic, self-motivation, and ability to work effectively in a either a team environment or independently.
• Has flexibility to accommodate to fast-paced work environment and deadlines.
• 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. 
• Attention to detail when utilizing PC or reviewing documents and editing/proof-reading documents.
• Applies strong analytical and business communication skills.
• Excellent verbal and written communication skills.
• Must be proficient in Word, Excel and PowerPoint.

JOB COMPLEXITY:

• Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Builds productive internal/external working relationships.
• Able to multi-task (review multiple batch records and track other documents that require follow-up for multiple vendors).
• Works with various CMOs and team members in a collaborative nature to ensure Exelixis project/program goals are met.
• Works on complex issues with the support of the supervisor where analysis of situations or data requires an in-depth knowledge of the manufacturing processes and corporate goals.

WORKING CONDITIONS:

• Environment: primarily working indoors in an office environment or meeting with clients.
• Some time at contract manufacturing facilities
• Travel required – 30% of domestic travel required 

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