Associate Director, Commercial Drug Production Manufacturing (Finance)
The Associate Director, Commercial Drug Product (DP) Manufacturing will be responsible for managing Exelixis' world class global drug product manufacturing operations for commercial products. This person will oversee Exelixis's commercial CMOs to ensure that the highest level of operational excellence is applied to all our manufacturing operations with the highest levels of compliance, quality and regulatory standards. This individual must have a "take charge" and "lead by example" attitude, a solid track record of dealing with external manufacturing, and deep underlying technical skills in small molecule solid dose products. This individual must have excellent command skills, complex problem solving abilities, outstanding communication skills, and the ability to apply creative solutions to solve complex issues. This positon will report to the Senior Director, External Commercial Manufacturing.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Oversee Exelixis DP CMOs to manage every aspect of commercial production including detailed oversight of all pre-production, production and post-production operations.
• Work as "person-in-plant" to oversee routine and critical commercial manufacturing operations at CMOs as needed.
• As the Manufacturing Subject Matter Expert, provide on-site technical support during critical production activities such as scale-up, equipment transfer, process validation and process optimization.
• Work closely with Analytical and Quality colleagues, providing technical expertise to drive CMO deviations and investigations to successful resolution.
• Utilize technical expertise to trouble-shoot manufacturing process issues.
• Assist CMO in determination of project design/scope and development of protocols for projects (scale-up, transfer, process improvement, validation, process improvement).
• Review and approval of Master Batch Records and Executed Batch Records, protocols and reports.
• Closely track and monitor manufacturing performance including deviations, batch record. comments, data trending, batch yields, and propose improvements to processes where efficiencies can be introduced.
• Possess a solid understanding of cGMP and regulatory strategy associated with manufacturing changes including SUPAC, ICH and CFR's.
• Work with logistics, planning functions and other stakeholders to ensure alignment across Pharmaceutical Operations and supply chain.
• Implement internal department SOPs to ensure that production oversight at CMOs is well documented with the best processes.
• This role will have 1-2 employees
• BS/BA degree in related discipline and 10 years of related experience; or,
• MS/MA degree in related discipline and 8 years of related experience; or,
• PhD in related discipline and 5 years of related experience, or;
• Equivalent combination of education and experience.
• Experience working with CMOs, both domestic and international.
• Experience troubleshooting manufacturing process issues, as well as participating in and leading investigations.
• Experience providing CMO on-site manufacturing technical support, including oversight of manufacturing issues and investigations.
• Experience working with and leading internal and external teams.
• Experience as technical expert taking drug product through the commercialization/launch process.
• Strong understanding of oral solid dosage manufacturing unit operations, including strong knowledge of equipment operation (e.g. high shear granulators; fluid bed dryers; tablet presses; capsule fillers etc.)
• Apply creativity, innovation and expert skills to contribute to Exelixis portfolio of small molecule commercial products.
• Identify and implement methods, techniques, procedures and evaluation criteria to achieve results.
• Lead or manage the work of others by providing guidance to subordinates or teams based on organizational goals and company policy, with responsibility for results, including costs, methods and staffing.
• Perform a variety of complicated tasks with a wide degree of creativity and latitude.
• Has complete understanding and wide application of technical principles, theories, concepts and techniques.
• Has good general knowledge of other related disciplines.
• Apply strong analytical and business communication skills, be able to present data and results concisely per relevant audience
• Proficient with broad use computer applications such as MS Office and specialized applications as needed for job.
• Work on very complex problems where analysis of situations or data requires an in-depth evaluation of various factors. May work on significant and unique issues where analysis of situations or data requires an evaluation of intangibles.
• Exercise independent judgment in methods, techniques and evaluation of criteria for obtaining results.
• Create formal networks involving coordination among groups.
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.