Associate Director/Director, Process Chemistry

Join a company that’s making a difference in the fight against cancer. Astex Pharmaceuticals, www.astx.com, is dedicated to the discovery and development of novel small molecule therapeutics with a focus on oncology. Astex is a wholly owned subsidiary of Otsuka Pharmaceutical Co. Ltd., Tokyo, Japan. We are looking for an experienced and motivated professional interested in applying their unique skills to our shared mission. This position will be based in our office located in Pleasanton, California near the Dublin-Pleasanton BART station in the Rosewood Commons campus: http://www.rosewoodcommons.com/transformation.html

The Associate Director/Director, Process Chemistry will be responsible for the process development and supply of small molecule drug substance (API), primarily oncology, for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities. All development projects are carried out entirely by outsourcing with various contract research or manufacturing organizations (CRO/CMO). Candidates should possess advanced pharmaceutical organic chemistry skills combined with exceptional project leadership, organization, and communication skills.

Responsibilities:

  • Execute on supply chain strategy for late stage (Phase 2 through NDA stage) clinical supply
  • Lead process improvement and clinical batch manufacturing for a late stage nucleotide-based API project at the CMO
  • Actively manage development activities including scale up and technology transfer at the CMO
  • Develop a control strategy, process acceptance ranges, operating ranges, and documents in preparation of the validation campaign
  • Collaboratively work with multiple groups within the organization to support the development of the API supply chain in preparation for the NDA and commercial launch
  • Select CMOs for project-specific activities
  • Actively work with contract research organizations to optimize the crystallization process for the last synthetic step of the API
  • Identify source for starting materials and intermediates, and develop plans for consistent and continuous supply
  • Identify key process parameters and relevant in-process controls
  • Derive origins of process impurities and steps for their control, mechanistic studies of reactions when needed, and actively work with contract research organizations on synthesis or isolation of  process impurities
  • Represent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
  • Support regulatory submissions by writing, reviewing, and approving specific sections
  • Act as the technical subject matter expert (SME) internally for troubleshooting and other internal assessments
  • Review and approve batch documents for drug substance manufacturing
  • Maintain process trend data to understand process changes
  • Travel: Up to 30%

 

Qualifications:

  • MS or PhD, Organic Chemistry or Chemical Engineering
  • Pharma/biotech industry experience in pharmaceutical process development and drug substance manufacturing preferably at a commercial level for small molecules in oncology (minimum 9 years with an MS, 6 years with a PhD)
  • Ability to work independently in a fast-paced environment
  • Thorough knowledge of process chemistry and scale-up with a proven track record in developing and implementing robust and efficient drug substance manufacturing processes
  • Experience handling technology transfer and technical support including OOS, deviations, and troubleshooting of drug substance manufacturing processes
  • Extensive experience collaborating with and overseeing CMOs and third-party manufacturers
  • Experience handling process capability studies to support process validation in drug substance manufacturing
  • Ability to validate late-stage or commercial manufacturing drug substance processes and a proven track record in cGMP manufacturing
  • Broad knowledge of regulatory and quality requirements for pharmaceutical products
  • Experience reviewing and/or authoring CMC section for regulatory submissions
  • Exceptional communication,  collaboration, and problem-solving skills ensuring alignment with other functions

Astex Pharmaceuticals is an Equal Opportunity Employer