Manager, Translational Medicine Operations Scientist, Chemistry
SENIOR MANAGER/ASSOCIATE DIRECTOR, FORMULATION DEVELOPMENT GROUP

BRIS 1.007

We are seeking a motivated candidate to join the Formulation Development Group within the Technical Operations of UNITY Biotechnology.

The Formulation Development Group (FDG) supports programs across the stages of preclinical and clinical development and provides technical leadership towards clinical drug product process development and technology transfer. Additionally, FDG provides technical support for drug product GMP manufacturing.

The candidate will be accountable for all pre-formulation and formulation development related activities, with primary focus on preclinical and early-stage development. The candidate will be a formulation expert with experiences in pulmonary, ophthalmic and parenteral delivery.   Additionally, the position will be responsible for representing Technical Operations in core team meetings and providing timely updates to the overall Technical Operations function for development direction, and will provide technical support towards non-GMP & GMP operations.

 

Responsibilities

  • Conduct pre-formulation and formulation activities to support early development candidate selection, which includes in vivo and in vitro PD studies, DMPK studies, non-GLP and GLP studies.
  • Conduct short term stability studies to ensure formulations under consideration are stable during study duration.
  • Accountable for formulation process development and technology transfer to CMOs for GMP manufacturing.
  • Under the guidance of the Director of Formulations Development, help to implement and maintain a state of the art formulation development laboratory in FDG.
  • Responsible for technical leadership towards key formulation decision as part of the overall selection evaluation process for advancing molecule for development.
  • Represent Technical Operations in program core team meeting and coordinate strategy with other functions to prioritize and meet Technical Operations deliverables.
  • Interact effectively & build successful relationships with members of the FDG, and with other UNITY stakeholders (Drug Substance Manufacturing, Project Management, Quality, Analytical Development/QC, Regulatory, Medicinal Chemistry, Clinical Operations & Discovery Biology).
  • Interact with senior managers and scientists, peers and senior management to create efficient development practices within FDG.
  • Will consistently seek out, recognize and assesses new technologies to facilitate efficient and reliable & robust formulation development within FDG.

REQUIREMENTS:

Requirements

  • PhD. in Chemical Engineering or Pharmaceutical Sciences (or related discipline) with 8+ years of relevant industry experience.
  • Experienced in parenteral, ophthalmic and pulmonary formulation development, drug product process development, and technology transfer.
  • Experienced in High Pressure Liquid Chromatography (HPLC) as analytical tool for evaluating formulation stability
  • Experience with DSC, TGA, XRPD, and other advanced formulation scientific equipment.
  • Thorough understanding of GMPs, ICH guidelines, QbD, and industry best practices.
  • Experienced leader in a cross functional setting that requires frequent interaction with internal and external stakeholders relevant to early-stage formulation development.
  • Must be a motivating and positive influence on the team.
  • Must have excellent oral and written communication skills.
  • Experience in implementation and managing a laboratory is preferred.
  • Proven ability to think creatively, and to obtain solutions to complex and diverse problems, and quickly adapt to changes in project direction.

Please send resume and cover letter