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:

• B.S. /M.S./Ph.D. in one of the relevant Engineering, Pharmaceutical Sciences, or other related Science fields. Formal project management and/or Lean Six Sigma certifications preferred.
• A minimum of twelve (12) years of engineering work experience, preferably in pharmaceutical development and manufacturing environment, and hands-on or technical training in the field of process engineering depending on level of education.
• Strong understanding of development, scale-up, validation and technology transfer; cGMP, FDA, EU, ICH guidelines; as well as CMC content of regulatory submission.
• Strong understanding of Aseptic technique with the knowledge and skills to work in a sterile environment.
• Demonstrate scientific knowledge relevant to development and manufacture of drug products including Ophthalmic or sterile dosage form (optional).
• Drug product manufacturing process design and scale-up including equipment, testing, assembly operations and support systems.
• Current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory and safety compliance requirements and guidelines.
• Pharmaceutical industry practices with aseptic manufacturing and combination product experience preferred.
• Strong problem-solving and decision-making abilities.
• Exceptional organizational skills and attention to detail.

A Few Other Details Worth Mentioning:

• The position will work remotely and require frequent travel to the EU. Residence on the east coast of US preferred.
• We are passionate about our culture! Our Tarsans live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact!
• This position reports directly to our Director, Technical Operations
• Travel required –25 - 50% (overseas)

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: https://alliantbenefits.cld.bz/25tarsusbenesnap.

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