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Manufacturing

Vice President, Manufacturing Operations & Supply Chain Management


Let’s talk about the Role

The VP Manufacturing Ops & Supply Chain Management (SCM) will be accountable for the overall CMC development, manufacturing and supply chain strategy for clinical and commercial supply of drug substance, drug product and IMP. They will determine operations and manufacturing strategies to ensure attainment of financial and strategic goals, translating strategy into tactics, priorities and resource requirements. In addition, they will oversee the execution of manufacturing, materials, procurement and logistics and manages the production from early-stage product development to commercial manufacturing upon FDA approval. The VP will also be responsible for outsourcing strategies and partnership management to achieve successful outcomes.

Let’s talk about some of the key responsibilities of the role:

  • Leads the CMC & Manufacturing/Tech Ops team and function
  • Logistics strategy and oversight of supply chain management activities to deliver products to clinical trials and/or market within defined regulatory, legal, quality and cost standards
  • End to end supply value chain for both the products interacting and interfacing with the global drug substance and drug product CMOs, CPOs, Serialization Track and Trace partner, and 3PL
  • Negotiating contract supply agreements, SOWs, and master service agreements with CMOs/CDMOs/Suppliers
  • Management of development project with third party manufacturers to achieve launch timelines
  • Being the chief liaison for partner projects at global level from CMC and supply chain standpoint

Factors for Success:

  • Bachelor of Science in one of the relevant Engineering or Science fields. Masters strongly desired
  • Minimum of 15 years of experience in manufacturing of novel therapeutics, in a GMP/FDA regulated pharmaceutical company
  • Experience in supporting Phase-III programs
  • Experience in the production of complex products from planning through procurement, negotiation and execution
  • Demonstrated leadership capability and track record of developing and leading high-performance teams
  • Extensive experience in technical transfers, qualification, validation, trouble shooting, NDA’s, FDA inspections, process scale-up, and commercial operations support
  • Experience with managing contract manufacturing organizations and familiarity with international supply chain architectures including vendor selection, qualification, and contracting; understanding of the inbound quality control for materials and components production with fast time-to-market and cost-sensitivity requirements
  • Ability to provide excellent guidance on compliance matters
  • Outstanding written and verbal communication/listening and presentation skills
  • Demonstrated problem solving abilities and strong organizational skills
  • Bring a history of great collaboration/teamwork; have a reputation for successful partnering with internal and external stakeholders
  • Ability to work successfully in a small organization
  • Pragmatic, solution-oriented thinker who possesses a “can do” and” whatever it takes” attitude, coupled with excellent organizational and communication skills (verbal, written, listening, conveying messages)
  • Strong interpersonal skills with the ability to motivate and influence others, negotiate cross functionally for positive outcomes and establish the best forward path in the face of competing points of view
  • Willingness to travel to achieve successful outcomes

A Few Other Details Worth Mentioning:

  • We are currently encouraging a virtual work environment due to covid-19, but the position will be based in our beautiful Irvine office.
  • This position will ultimately report directly to the Chief Operations Officer

#LI-CN1

#LI-Remote

Equal Employment Opportunity Employer

At Tarsus Pharmaceuticals, we value bringing together individuals from diverse backgrounds to drive better results for patients. As an equal opportunity employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. Equal Employment Opportunity is the law, and you can find more information here. If you are an applicant and would like to request an accommodation, please email careers@tarsusrx.com.

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Manufacturing

Vice President, Manufacturing Operations & Supply Chain Management


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