Sr. Director of Manufacturing and Packaging - 1126San Bruno, CaliforniaThe PositionThe Senior Director of External Manufacturing and Packaging will be responsible for overseeing and advancing world-class global manufacturing and packaging operations for commercial and clinical product portfolios. This position will work closely with our external contract manufacturing organizations to ensure that our manufacturing strategy is aligned with our clinical and commercial needs. The person should have a good regulatory understanding of process variations and Module 3 improvements that would be required as part of the normal lifecycle management of our products. Importantly, this role will closely manage performance metrics for production to ensure delivery is on time and on the budget. This position will report to a VP.The Essential Duties & ResponsibilitiesEstablish effective relationships with all manufacturers to help to oversee activities with CMOs and with internal teams to ensure DS and DP are manufactured on time and with quality to meet companies needs.Develop, track, monitor and manage metrics for manufacturing operations and batch delivery.Identify and drive process improvements and change management within external manufacturing, including scale up.Establish and lead regular review meetings with vendors for performance evaluations.Help to evolve manufacturing and packaging footprint based on the business needs including identification of additional vendors and CMOs as needed.Define key metrics and lead the manufacturing group to measure continuous improvement in the function internally.Partner with logistics and planning functions and stakeholders within PSC to ensure alignment across Pharm Ops and supply chain.Partner closely with Quality operations to ensure that contractors are qualified and approved within our system.Assist in serialization readiness at all of our manufacturing plants.Implement internal department SOPs to ensure that production oversight at CMOs is well documented with the best processes.There are no supervisory responsibilities at this time but may supervise one or more employees, typically in administrative or professional individual contributor roles.Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.Uses professional concepts and company’s policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.Networks with key contacts outside own area of expertise.Education & ExperienceBS/BA degree in related discipline and eleven years of related experience;MS/MA degree in related discipline and nine years of related experience; orAn equivalent combination of education and experience.May require certification in assigned area(s).Typically requires a minimum of 15 years of related experience in Manufacturing, Packaging and Labeling inpharmaceutical or biotech industry and/or combination of experience and education and trainingExperience working with CMO in a manufacturing role is a must; you must have experience working with the CMO and track record of working with external contract organizations and thorough understanding of regulatory legislation, quality, compliance in commercial manufacturing is a must.Must have good technical knowledge in manufacturing and packaging with a good track record.Small molecule experience required. Oral solid dosage form strongly desired. Experience with serialization is desired.Strong and effective interpersonal and leadership skills in a fast-paced environment. Team player with high integrity, passion, courage, and ingenuity.Ability to communicate clearly and concisely both verbally and in writing, and has demonstrated strong experience and skills in authoring regulatory submissions.Up to 20% travel may be required
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