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(Senior) Clinical Trial Manager (Senior) Clinical Trial Manager
DIRECTOR OF CHEMICAL DEVELOPMENT

2.102

UNITY Biotechnology is seeking you, an exceptional and highly motivated free spirit, to lead the Chemical Development team. Reporting to the VP of Technical Operations, you will drive chemical development activities across a dynamic (dare we say “revolutionary?”) development and discovery space. The successful candidate will be flexible, demonstrate spirited leadership skills, and possess experience in developing robust chemical processes to support a scintillating variety of small-molecule-based clinical programs.

Hybrid with Travel

What You’ll Do

  • Take charge of phase-appropriate synthetic route design and practical implementation of synthetic processes while aptly addressing process liabilities and rapidly executing process improvements
  • Establish drug substance control strategies in early development with an eye toward the long-term vision of the commercial process
  • Collaborate with cross functional teams to ensure seamless transitions between drug substance programs and vendors and their drug product counterparts
  • Coordinate internal and external quality control, quality assurance, and regulatory organizations to resolve technical issues and deviations
  • Make the people around you smile, because if chemical development can’t make you smile, what can?
  • Manage multiple drug substance CMO activities and manufacturing operations for projects under development, including technology transfer
  • Provide critical and sagacious input on master batch records, stability protocols, SOPs, process investigations, and product dispositions for GMP activities
  • Author regulatory documents, including initial submissions, amendments, requests, and NDAs
  • Invest in the department’s quality culture by maintaining and building an environment that is focused on continuous improvement and learning
  • Build appropriate risk management and life-cycle strategies for chemical development manufacturing
  • Travel up to 10% of your time for scientific project management and monitoring of critical project activities

REQUIREMENTS:

About You

  • PhD in synthetic organic chemistry, minimum of 10 years of experience in the small molecule pharmaceutical industry
  • Hands-on laboratory experience in the rivetingly multifarious clinical stages of drug substance development
  • Chemical development experience with chiral molecules and chiral crystallizations preferred
  • Proven ability to work collaboratively on multiple projects with numerous stakeholders in and outside the Technical Operations team
  • Know anything about walruses? It might be useful.
  • Comprehensive understanding of the synthetic and analytical techniques necessary for proper polymorph screening, optimization, and patent protection
  • Extensive knowledge of GMPs, GLPs, ICH guidelines, and industry best practices
  • Thorough understanding of Design of Experiments (DoE), Quality by Design (QbD) principles, and other “Capital – Lower-Case – Capital” acronyms
  • 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.

Please send resume and cover letter