Senior/Executive Director of Formulation Development

UNITY Biotechnology craves an exceptional and highly motivated individual to lead the Formulation Development group. Reporting to the Head of Technical Operations, you will oversee formulation activities across a dynamic (dare we say “industry-changing?”) development space and develop reliable and cost-effective outsourcing strategies for late phase drug product development. You have strong leadership skills, an extensive background in sterile injectable products (parental and/or IVT administration), and are well versed in late-stage pharmaceutical development of small molecules.

Hybrid

What You’ll Do

• Work closely with other senior members of the Technical Operations group to evaluate and select pharmaceutical development and manufacturing CROs and CMOs that are aligned with UNITY’s development strategy
• Spearhead project leadership and management of multiple drug product CMOs/CROs, including technology transfers and person-in-plant as part of outsourcing oversight
• Prepare and oversee future drug product registration and validation batches
• Continually manage relationships with drug product CMOs/CROs to ensure appropriate resources dedicated to UNITY projects
• Lead contract negotiations for drug product development activities at CMOs/CROs to ensure cost projection well aligned with UNITY’s budgetary estimates
• Lead CMC meetings and serve as the Operations Group representative on internal, multidisciplinary project teams
• We’re not saying we spontaneously erupt into full-voice sea shanties, but we’re not not saying it either
• Review and approve master batch records, stability, and development reports for GMP activities
• Author regulatory documents, including IND, IND amendment, NDA, and technical reports
• Collaborate brilliantly with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations
• Control alignment and understanding of phase-appropriate analytical and quality requirements for GMP drug products
• Travel (up to 15% of your time) to foreign and domestics contractors for scientific project management and monitoring of critical project activities

REQUIREMENTS:

About You

• Ph.D. in pharmaceutical sciences, chemical engineering, or chemistry with a minimum of 12 years of formulation and drug product development
• Successful track record of developing parental and/or IVT formulations in vial and pre-filled syringe presentations
• Experience with and first-hand use of common pharmaceutical and analytical equipment
• Extensive understanding of GMPs, GLPs, ICH guidelines, and industry best practices
• Understanding of the elements of Quality Management Systems and building a strong culture of quality
• Experience with lifecycle product management
• Strong verbal communication, written communication, and organizational skills, and it will help our irregular Laugh-Olympics if you’re also good at charades
• Ability to work collaboratively on multiple projects with numerous stakeholders in- and outside of the Technical Operations group
• Commercial experience desirable, though not strictly necessary
• Familiarity with the overall drug development process beyond pharmaceutical development
• Collaborative work style coupled with dedication to results, with an appreciation for UNITY’s mission to solve the problems of aging amid an engaged, fun, and rollicking work environment

Compensation

Prioritizing a coterie of accomplished, well-rounded, and convivial colleagues, UNITY offers a competitive compensation package, including salary, non-trivial bonus targets, equity participation, and robust benefits and perks.