Work at Tarsus

Pharmaceutical Sciences

Sr Manager, Pharmaceutical Sciences


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

  • Leads TP03 activities and functions 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, clinical pilot manufacturing and final commercial manufacturing process. Coordinate and facilitate transfer of product manufacture to additional CMO site(s).
  • Responsible for leading and overseeing all aspects of the manufacture of TP03 at CMOs and ensures adherence to project timelines to support animal PK, toxicology and/or clinical supply in line with business objectives. Establish and manage relationship with CMOs.
  • Reviews and provides oversight of all documentation related to the production of Tarsus’s products including but not limited to formulation development, scale-up protocols/reports batch records, deviations, SOP’s, etc. Contributes to setting up specifications for drug product. In conjunction with the CMO and other groups related deviations and leads or conduct root cause analysis and implement proposed corrective actions at CMO.
  • Facilitate manufacturing, packaging, and distribution of TP03 clinical trial material activities and work collaboratively with supply chain manager.
  • Provides TP03 products technical support including technical interface with 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.
  • Lead and/or perform TP03 and TP04 formulation development assessment. Conduct formulation development in laboratory to support technical assessment if necessary.
  • Collaborate with analytical team to conduct formulation experimental assessment.
  • Supports due diligence assessments of potential intellectual property and business development opportunities.
  • TP03 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.
  • 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 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.

A Few Other Details Worth Mentioning:

  • The position will be based in our beautiful Irvine office, complete with a courtyard, table tennis, snacks and drinks, occasional catered meals, and pet-days.
  • This position reports directly to the Director, CMC, and Technical Operations
  • Some travel may be required – up to 20%

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.

Pharmaceutical Sciences

Sr Manager, Pharmaceutical Sciences


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