Associate Director, Technical Operations

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

• Responsible for leading and overseeing all aspects of the manufacture of commercial drug product at CMOs as person-in-plant and ensures adherence to project timelines to support commercial supply, in line with business objectives. Establish and manage relationship with CMOs.
• Responsible for CMO on-site review and oversight of all documentation related to the production of Tarsus's products including but not limited to batch records, change controls, deviations and investigations, scale-up protocols / reports / batch records, SOP's, etc. Oversee related deviations and lead or conduct root cause analysis and implement proposed corrective actions in conjunction with the CMO and other Tarsus groups.
• Coordinate and oversee batch release process ensuring timely and efficient completion of documentation review; Act as the primary liaison between QA teams, CMO stakeholders, and other departments to streamline communication and collaboration; Anticipate potential issues in the QA review process and proactively develop solutions to minimize risks.
• Support commercial drug product activities and functions for scale-up and process validation at CMO sites providing product and process design input, defining specifications for equipment, selecting equipment suppliers, and locking down formulation, and final commercial manufacturing process. Coordinate and facilitate transfer of product manufacture to additional CMO site(s).
• Provides products technical support including technical interface with channel partners, regulatory, quality, project manager, contract manufacturers, vendors, and suppliers.
• Supports regulatory CMC activities including writing and / or reviewing drug product regulatory submission and ensures that documents are prepared in accordance with regulatory guidelines.
• Collaborate with Pharmaceutical Sciences team to conduct finished product experimental assessment (for investigational purpose).
• Tracks CMO KPIs and plan accordingly for manufacturing process / yield improvements.
• Reviews and performs complaints investigation and reviews APR data and plan accordingly for manufacturing process / formulation improvements.
• Supports due diligence assessments of potential intellectual property and business development opportunities.
• project budget planning and budget management.
• May perform other related duties as required and / or assigned.

Factors for Success :

A Few Other Details Worth Mentioning :

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $161,200 - $225,800 plus bonus, stock equity, and comprehensive benefits. The base pay range reflects the target range for this position, but individual pay will be determined by additional factors such as job-related skills, experience and relevant education or training. Our benefits include health, dental and vision insurance benefits to ensure your well-being. We believe in work-life balance and offer generous paid time off, including vacation, holidays, and personal days. For more details regarding Tarsus benefits, please visit :

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Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

Salary : $161,200 - $225,800