Associate Director, Process Development

Newark, CA
Jun 17, 2022
Biotech Bay
Required Education
Position Type

Associate Director, Process Development

   Are you ready to join a growing, innovative, precision oncology powerhouse? Rain Therapeutics is committed to building a passionate core team of scientific, clinical, regulatory, and business leaders to bring new targeted therapies for cancer patients struggling with limited treatment options. Our focus has been and will continue to be new oncology therapeutics based on targeting the biological drivers of the cancer, regardless of tumor type.

The Associate Director, Process Development will be part of process chemistry and drug substance development team for all of Rain Therapeutics' small molecule programs, including the development of chemical routes and the optimization of chemical processes. The successful candidate will direct and oversee contract development and manufacturing organizations (CDMOs) as well as lead process development efforts in preparation for successful process validation and NDA/MAA submissions as well as commercial launch. This position reports to the head of Chemical Development. 

Key Performance Objectives:

• Lead and manage CDMO activities for late-stage development (e.g., tech transfer, scale-up/process development/optimization and from process validation through commercialization)

• Lead process development studies according to the principals of Quality by Design (QbD), specification justification studies to establish limits, process characterization studies such as one-variable-at-time (OVAT) and DOE studies to identify proven acceptable ranges (PARS) of critical process parameters (CPP), including identification of edge-of-failure (EoF), characterization of APIs to identify critical quality attributes (CQA).

• Direct the CROs/CMOs in terms of chemical development strategies during clinical development and design of registration strategies for commercial supply chain(s), review, and approval of release testing data, as well as stability data.

• Review quality control testing and certification to guarantee that batches meet specifications and are in compliance with cGMP; and document and institutionalize all development activities as source materials for regulatory filings.

• Author and review validation related documents and process development reports

• Actively contribute to writing key CMC sections of regulatory documents IND/IMPD/NDA/MAA.

• Drive continuous improvements in the drug substance development process through technological innovation and problem solving.

• Serve as subject matter expert in drug substances and help drive best practices and technical advancements.

• Deliver progress reports and presentation to ensure management awareness and engagement of the status, progress, and future program and functional needs.

• Design chemical development strategy that is phase-appropriate and well positioned for accelerated development, and design and execution of validation master plan to support commercialization.

Preferred Education and Experience:

• Ph.D., MS, or BS in Organic Chemistry, Chemical Engineering (or related discipline) with at least 8+ years of progressively broad experience in the Pharmaceutical or Biotech industry with demonstrated track record of successfully validating API required.

• Demonstrated expert knowledge in regulatory/cGMP requirements (for both the US and EU Directive) as applied for CMC development strategy and demonstrated success in the application of QbD principles

• Solid ability to effectively communicate to functional groups across all levels of the organization and competent authorities.

• Demonstrated success in shepherding late phase drug substance characterization to validation, pre-approval inspection and commercial manufacturing.

• Extensive experience in managing contract manufacturing organizations in North America, Europe and Asia.

• Strong leadership, interpersonal communication, collaboration and problem-solving skills (especially process chemistry related) along with strengths in delivering results on firm deadlines in support of development programs.

• Organizational and planning skills required to determine appropriate resources for resolution of problems.

• Ability to travel domestically and internationally up 25% of the time required.

• Ability and willingness to be fully vaccinated against Covid-19 and similar diseases