Sr Director, Commercial Manufacturing will be responsible for advancing Exelixis’ world class global manufacturing and packaging operations for commercial products. This person will lead and oversee Exelixis’s key partner contract Drug Product manufacturers to ensure that the highest level of operational excellence is applied to all our manufacturing and packaging operations with the highest 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. They 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 VP of Pharmaceutical Operations and Supply Chain.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
• Oversees all Exelixis DP manufacturers to ensure manufacturing excellence. Leads a team to manage every aspect of commercial production and packaging operations.
• Provides oversight at our CMOs to ensure that pre-production, production and post-production operations run flawlessly. Ensures that Exelixis CMOs have enough raw materials and components available to produce batches that includes detailed oversight of all production operations, data, IPCs, batch records and all key documentation for both manufacturing and packaging.
• Closely tracks and monitors manufacturing performance including deviations, batch record comments, data trending, batch yields, and propose improvements to processes where efficiencies can be introduced.
• Ensures our products are in compliance with quality and regulatory standards to ensure that our products are made to the required quality and regulatory standards.
• Works with logistics, planning functions and stakeholders within PSC to ensure alignment across Pharm Ops and supply chain.
• Assists in growing Exelixis manufacturing and packaging footprint based on the business needs including identification of additional vendors and CMO’s as needed.
• Implements internal department SOPs to ensure that production oversight at CMOs is well documented with the best processes.
SUPERVISORY RESPONSIBILITIES:
Will supervise 2-3 employees.
REQUIREMENTS:
• Ph.D with related discipline and nine years of related experience; or
BS/BA degree in related discipline and fourteen years of related experience; or
MS/MA degree in related discipline and twelve years of related experience; or, 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 Labelling in pharmaceutical/biotech industry and/or combination of experience and education/training
• Experience working with CMOs in a manufacturing role is a must. Track record of working with external contract organizations and thorough understanding of regulatory legislations and quality/compliance in commercial manufacturing is a must.
• Experience in scaling products, and be able to apply knowledge and knowhow to create an effective plan in partnership with our CMOs.
• This individual must have great perspective and understanding of cross-functional technical disciplines and in particular understand the importance of inputs into the drug product such as physical properties of the active pharmaceutical ingredient and crystal form.
• Must have phenomenal technical knowledge in manufacturing and packaging with an outstanding track record.
• Small molecule experience required. Oral solid dosage form strongly desired. Experience with serialization is desired.
• Applies sound judgment, technical knowhow and knowledge gained from past experience to all Exelixis commercial products, and excel at triaging complex problems and issues to find the right solutions.
• 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
JOB COMPLEXITY:
• 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.
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