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.
