Principal Scientist/ Director, Process Chemistry

ASTEX   •  

Pleasanton, CA

Industry: Pharmaceuticals & Biotech

  •  

15+ years

Posted 99 days ago

The Director, Process Chemistry will act as a technical subject matter expert (SME) and project lead for the supply of small molecule drug substance (API), primarily oncology, during all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities.In this role, the Director will manage development and manufacturing activities performed by Contract Manufacturing partners to ensure that projects are completed in an efficient and timely manner and that the final products meet Astex Specifications and are fit for their intended use. 

The  Director is a team player, an open and willing communicator of knowledge and experience.  He/she will work closely with internal teams, providing timely and detailed progress updates.

 

Responsibilities:

  • Act as the technical subject matter expert (SME) internally for troubleshooting and other internal assessments
  • Manage process improvement and clinical batch manufacturing for API projects at the CMO
  • Actively manage development activities including scale up and technology transfer at the CMO
  • Collaboratively work with multiple groups within the organization to support the development of API supply chains in preparation for the NDA and commercial launch
  • Design synthesis schemes, identify key process parameters and relevant in-process controls
  • Develop a control strategy, process acceptance ranges, operating ranges, and documents in preparation of the validation campaign
  • Derive origins of process impurities and steps for their control, develop mechanistic studies of reactions, and methods for isolation of products as needed
  • Ensure successful technology transfer to CMOs globally
  • Represent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program
  • Review and approve batch documents for drug substance manufacturing
  • Maintain process trend data to understand process changes
  • Write technical reports and API sections for regulatory filing
  • Manage synthetic chemistry experiments in the chemical laboratory as needed
  • Travel: Up to 30%

Qualifications:

  • MS or PhD, Organic Chemistry
  • Pharma/biotech industry experience in pharmaceutical process development and small molecule drug substance manufacturing (minimum 15 years with an MS, 10 years with a PhD)
  • Ability to work independently in a fast-paced environment
  • Thorough knowledge of process chemistry and scale-up from original, “medicinal chemistry” routes through kilo lab to pilot plant, with a proven track record in developing and implementing robust and efficient drug substance manufacturing processes
  • Experience handling process capability studies to support process validation in drug substance manufacturing.  This may include knowledge of Design of Experiment (DOE), statistical analysis, Quality by Design (QbD), Critical Process Parameters (CPPs) and Proven Acceptable Range (PARs).
  • Experience handling technology transfer and technical support for batch record reviews including OOS, deviations, and troubleshooting of drug substance manufacturing processes
  • Knowledge of regulatory and quality requirements for pharmaceutical products
  • Ability to validate late-stage drug processes
  • A proven track record in cGMP manufacturing
  • Extensive experiencecollaborating with and overseeing CMOs and third-party manufacturing
  • Cross-collaboration with Quality Assurance, Analytical Chemistry, and Regulatory is a plus
  • Exceptional communication,  collaboration, and problem-solving skills ensuring alignment with other functions

18-11R