We are seeking a highly motivated individual to join Turning Point Therapeutics as a VP of CMC Operations . The VP of CMC Operations will report directly to the President/CEO and will be the strategic and technical lead for all small molecule pharmaceutical development related activities including drug substance process development and manufacturing, drug product formulation development and manufacturing, analytical development and quality control, supply of clinical trial materials (CTM) and logistic, regulatory CMC.
- Overall responsibility for managing all drug substance and drug product activities transitioning from preclinical development to clinical development through clinical trial material supplies for clinical phase studies and eventual transition to commercial supply.
- Provide guidance and direction for project strategy, goals, budgets and other operational activities. Acting as the senior technical leader for the CMC function, integrating internal and external team members’ activities into the pharmaceutical development plan and presents plans and progress to the Senior Leadership Team.
- This position also requires a minimum ten years of management/supervisory experience, and proven ability to work collaboratively and communicate effectively on a multi-disciplinary team. Substantial experience in managing US and International CDMOs for the manufacture of cGMP APIs and DP.
- Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 and commercialization and solid understanding of all facets and phases of CMC drug development.
- Experienced with regulatory CMC filings in IND, NDA, IMPD, PAS covering all phases of pre-clinical and clinical development in both the US and ex-US markets; thorough knowledge of relevant FDA and EMA regulations.
- Good written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators).
- Proven track record of moving drug candidates from early phase development to commercial lunches.
- Adept at creating and communicating a clear vision among direct reports, effectively aligning resources and motivating teams to achieve goals. Demonstrated success managing multiple assignments with timely and accurate output.
- Develop and implement strategy for identification, selection and management of Contract Development Manufacturing Organizations (CDMOs) for process/formulation development, cGMP manufacture and supply of Clinical trial materials (CTMs) for clinical development programs.
- With functional lines, develop overall DS and DP material supply strategy for all pre-clinical and clinical activities and manage the resulting budgets and timelines.
- Collaborate with the clinical team to establish a supply chain for clinical trial materials (CTMs).
- Direct efforts to implement phase appropriate analytical methods development and validations to ensure CDMOs are using systems and processes in compliance with all relevant regulatory standards.
- Through CDMOs, execute plans for the registration and validation of DS and DP as required by cGMP, ICH (International Conference of Harmonization) and FDA regulations.
- Direct the writing and reviewing documents for INDs, NDAs and other regulatory section submissions; represent the company as the CMC expert before U.S. and European regulatory authorities.
- The position requires a Ph.D. in Chemistry, Pharmaceutical Science, Chemical Engineering or related field and a minimum fifteen years of small molecule CMC development experience in a pharmaceutical or biotechnology CMC/cGMP environment.
- Substantial Experience implementing technical, strategic and operational plans.
EEO & Employment Eligibility
TP Therapeutics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. TP Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. TP Therapeutics is an E-Verify employer.
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