Compensation Overview

About the Role

Reporting to the Sr. Director, Pharmaceutical Sciences, the Associate Director, Pharmaceutical Sciences will provide scientific, technical, and hands-on leadership in formulation development and manufacturing.  The qualified candidate will have demonstrated leadership skills in managing an in-house laboratory and formulation team, provide strategic knowledge in designing and implementing novel formulations, be responsible for formulation development from lead optimization to clinical development, have extensive experience and knowledge in pre-formulation research, formulation development, and process selection.  The qualified candidate will also, provide technical input and oversight related to formulations including development work outsourced to CMOs and contracting testing laboratories, be responsible for the development of scalable manufacturing processes and CMO management for clinical supplies. The role will contribute to global regulatory CMC dossier preparation (INDs, IMPDs NDAs).  

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

• Leads formulation and process development of Tarsus products to be delivered through ocular, oral and dermal routes.
• Leads an in-house laboratory and formulation development team responsible for formulation development from lead candidate identification and optimization to clinical development.
• Providing 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.
• Leads 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. Coordinate and facilitate transfer of product manufacture to additional CMO site(s).
• 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. Reviews and provides oversight of all documentation related to the production of Tarsus’s products including but not limited to scale-up protocols/reports batch records, deviations, SOP’s, etc. Contributes to setting up specifications for drug products. In conjunction with the CMO and other groups related deviations and leads or conduct root cause analysis and implement proposed corrective actions at CMO.
• 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.
• 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 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.

A Few Other Details Worth Mentioning:

• The position will be based in our beautiful Irvine office, complete with a courtyard, snacks, drinks, and occasional catered meals. We provide a hybrid work environment. 
• 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 Sr. Director, Pharmaceutical Sciences.
• Some travel may be required – up to 20%.

At Tarsus, we understand the importance of attracting and retaining top talent. The expected base pay range for this position is $138,000 - $194,300 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/tarsus2024BenSnapshot. 

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