Job Description  Director Chemical Research & Development

SUMMARY:

The Director of Chemical Development will be responsible for the development and implementation of robust synthetic processes to support small molecule programs with the goal of delivering preclinical and clinical drug substance batches meeting program needs. This individual will be accountable for implementing phase appropriate strategies to develop synthetic processes that comply with regulatory requirements  and manufacture API to support clinical trials, registrational and commercial batches.

Specific responsibilities will also include but are not limited to the following;  managing drug substance and analytical method development, managing timelines for development and manufacturing activities performed at CMOs, tracking drug substance and drug product inventory levels, coordinating the distribution of clinical trial materials, coordinating cGMP vendor quality audits, maintaining all relevant files and reports required for regulatory submissions/health authority inspections/due diligence, and the authoring of the CMC sections of regulatory health authority submissions.

RESPONSIBILITIES:

  • Will directly lead and manage CMO activities
  • Direct formulation and process development activities for one primary program and contribute all development programs as needed
  • Provide manufacturing oversight for the production of drug substance
  • Regulatory writing to support CMC submissions
  • Manage Chemical Development group to deliver a robust chemical synthesis process for research and development programs
  • Responsible for phase appropriate synthesis route design, practical implementation of synthesis processes and controls for regulatory starting materials, intermediates and drug substances
  • Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process
  • Lead/Support technical transfer of starting material, intermediate or API processes between sites as needed
  • Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and vendors
  • Ability to coordinate with internal and external quality control, quality assurance, and regulatory personnel to resolve technical issues or deviations
  • Participate in an interactive, team oriented culture, interfacing primarily with the discovery functions and the CMC team
  • Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs can support the requirements of individual chemical development programs effectively
  • Implementation of risk based approach to development, QbD and DoE principles at appropriate development stages
  • Support PAR studies and pre-validation and validation activities for drug substance
  • Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings as needed
  • Build appropriate risk management strategies for chemical development and manufacturing
  • Up to 25% travel will be needed for scientific project management and monitoring of critical project activities

REQUIREMENTS:

  • Knowledge of current Good Manufacturing Practices (cGMP)
  • Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC
  • Proven ability to develop and implement strategic plans
  • Ability to effectively organize and prioritize tasks to achieve established deadlines
  • Demonstrated competencies in a core CMC discipline such as drug substance process development, drug product formulation development, drug substance manufacturing, and/or drug product production
  • Proven problem solving skills are a must
  • Must possess the ability to effectively manage multiple projects
  • Ability to adapt rapidly and change focus based on real time results and findings

EDUCATION:

  • Ph.D. or BS/MS with >15 years of experience in chemistry, chemical engineering, biomedical engineering, pharmaceutical sciences or closely related discipline with relevant solid oral drug product development experience

EOE