Orange Grove Bio is seeking a highly motivated Associate Director of CMC to join our rapidly growing team. The Associate Director will engage closely with Orange Grove Bio team members, program stakeholders, academic partners, and CRO/CDMOs to advance novel therapies into clinical trials. In addition, this position will perform project management duties to ensure the programs are running seamlessly.

Responsibilities:

  • Responsible for working closely and communicating effectively with cross-functional teams and leaders from all parts of Orange Grove Bio to ensure the team is set up to deliver on all CMC project requirements
  • Lead project management activities with the CMC department to include timeline management, creating/sending reports, vendor relations, etc.
  • Establish operational work plans with the CMO/CRO/CDMO, providing technical leadership and oversight of the program with an emphasis on technical guidance and troubleshooting, monitoring timelines and budget
  • Perform formulation development
  • Work closely with technology transfer offices
  • Assist in the creation of development plans aimed at bringing new therapeutics programs into the clinic and ultimately to patients
  • Develop an “informed perspective” of the life sciences sector and stay abreast of significant dynamics impacting public and private therapeutics companies.
  • Other duties assigned

Requirements:

  • Ph.D. or MS in Biology, Chemistry, Biotechnology, Pharmaceutical Sciences, Chemical Engineering, or another life science-related field
  • 4-7 years of experience in the biopharma industry with prior experience in CMC project management
  • Experience in process, formulation, and analytical development of small molecules and biologics with a clear demonstration of product development expertise and CMC knowledge is required
  • Working knowledge of lyophilization and delivery systems is preferred
  • Strong background in GxP (GMP, GCP, GLP)
  • Experience with regulatory agencies such as FDA and EMA are preferred
  • Comfortable in a fast-paced startup environment
  • Ability to work independently and juggle multiple projects

Diversity and Inclusion Commitment
At Orange Grove Bio, diversity, equity, and inclusion are part of our DNA. This drives a strong, positive culture, and that, in turn, drives innovation. Innovation means more therapies to help patients, and that means a healthier world.