Associate Director, Pharmaceutical Sciences

6 days ago

Irvine, California, United States Tarsus Pharmaceuticals, Inc. Full time
About the Role

We are seeking an experienced Associate Director, Pharmaceutical Sciences to provide scientific, technical, and hands-on leadership in formulation development and manufacturing. The successful candidate will have a strong background in pharmaceutical development and manufacturing, with a proven track record of leading cross-functional teams and managing complex projects.

Key Responsibilities:
  • Lead formulation and process development of Tarsus products to be delivered through ocular, oral, and dermal routes.
  • Manage an in-house laboratory and formulation development team responsible for formulation development from lead candidate identification and optimization to clinical development.
  • Provide hands-on management for in-house formulation development, including designing, planning, and executing experiments, interpreting analytical and process data, and coordinating activities with the analytical development department.
  • Lead early and mid-phase activities for new product technology transfer to CMO sites, providing product and process design input, defining specifications for equipment, selecting equipment suppliers, and locking down formulation and clinical manufacturing process.
  • Responsible for leading and overseeing all aspects of the manufacture of early and mid-phase products at CMOs and ensuring adherence to project timelines to E/L studies, support animal PK, toxicology, and/or clinical supply in line with business objectives.
  • Establish and manage relationships with CMOs, reviewing and providing oversight of all documentation related to the production of Tarsus's products, including but not limited to scale-up protocols/reports, batch records, deviations, SOPs, etc.
  • Work collaboratively with the supply chain manager to facilitate manufacturing, packaging, and distribution of early and mid-phase clinical trial material activities.
  • Provide early and mid-phase product technical support, including technical interface with regulatory, quality, project manager, contract manufacturers, vendors, and suppliers.
  • Support regulatory CMC activities, including writing and/or reviewing drug product regulatory submissions, and ensures that documents are prepared in accordance with regulatory guidelines.
  • Collaborate with the analytical team to conduct formulation experimental assessment.
  • Support due diligence assessments of potential intellectual property and business development opportunities.
  • R&D project budget planning and budget management.
Requirements:
  • 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.
  • At least 5 years of people management experience and within a growing virtual company environment preferred.
  • Strong understanding of development, scale-up, validation, and technology transfer; cGMP, FDA, EU, ICH guidelines; as well as CMC content of regulatory submission.
  • Demonstrate scientific knowledge relevant to formulation development and process development of small molecule/biologics and/or peptides to be delivered through ophthalmic and/or injectable routes. Knowledge of analytical skills related to identified formulation.
  • 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.
About Tarsus Pharmaceuticals, Inc.

Tarsus Pharmaceuticals, Inc. is an Equal Opportunity Employer. We are passionate about our culture and live our values of commitment to patients, empowerment to champion innovation, and teamwork to amplify impact. We offer a hybrid work environment and a comprehensive benefits package, including health, dental, and vision insurance benefits, generous paid time off, and a competitive salary range of $138,000 - $194,300 plus bonus, stock equity, and comprehensive benefits.

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