Reporting to the VP, CMC Operations, the Associate Director/Director, Drug Substance Process Development and Manufacturing will be responsible for managing the CDMO activities on process development and manufacturing of Repotrectinib as well as other Turning Point Therapeutics portfolio compounds.
Additionally, the incumbent will be responsible for the oversight of tech transfer, process registration, process characterization, process validation and commercial preparedness of the manufacturing at current and potential suppliers.
The successful candidate will have extensive experience managing contract development manufacturing organizations (CDMOs) in US, EU and Asia. This position will also require the preparation of key sections of regulatory documents (such as INDs, NDAs, MAAs and IMPDs).
- Develop and execute manufacturing and supply strategies of raw materials, regulatory starting materials (RSMs), and drug substance in US, EU and Asia.
- Assist with contract negotiations and budgeting for DS related manufacturing, testing and release.
- Actively participate in the selection and evaluation of new third-party contractors and suppliers for process development and manufacturing activities in the US, EU and Asia.
- Manage routine CDMO project activities including co-hosting weekly t-con, reviewing weekly update, writing meeting agenda and meeting minutes, etc.
- Coordinate document review activities to ensure the quality and timeline of review.
- Participate and support all quality events including discrepancy/deviation/OOS/OOT investigations.
- Contribute to Quality/CMC related regulatory correspondence and applications (IND/NDA/IMPD/MAA).
- Onsite management of key development and manufacturing events including kick-off meeting, registration campaign and process validation campaigns in CDMO.
- Establish adequate documentation processes and systems to ensure robust document review and approval on time.
- Identify and mitigate potential quality and regulatory risks for drug substance manufacturing and subsequent resolution of compliance and quality issues.
- Represent drug substance function in interdisciplinary and technical project teams as needed.
- PhD in Organic Chemistry or Chemical Engineering with more than 10 years of development and manufacturing experience or BS/MS with 15 years of experience.
- Experience with late stage process development, process validation and commercial launch.
- Strong understanding of FDA/EMEA/ICH/cGMP guidance.
- Prior experience with regulatory submissions a plus.
- Demonstrated ability to effective lead projects with internal and external resources.
- Approximately 25% travel required
EEO & Employment Eligibility
Turning Point 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. Turning Point 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. Turning Point Therapeutics is an E-Verify employer.
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