Associate Director/Director, Drug Product Process Development Development
3 months ago
Summary and Scope:
Tempest is a dynamic clinical-stage oncology company developing innovative therapies to improve patient lives. We are seeking an Associate Director/Director, Drug Product Process Development to join our Technical Operations team. This position will lead the drug product technical development plan for all products in Tempest’s pipeline. This position will report to our Vice President of CMC and Medicinal Chemistry.
Guiding Principles: The below principles drive all that we do here at Tempest. We are looking for like-minded individuals that feel passionately about these same principles to join our team.
- Develop meaningful therapies for patients
- Value diversity in building teams
- Commit to growth and collaboration
- Work with integrity and rigor
- Embrace the energy that drives a successful biotech
Responsibilities (not limited to the below and may evolve over time and change depending on business needs and individual expertise):
- Collaborate and work closely with Quality Assurance, Regulatory Affairs, Analytical Development, Clinical Operations, Legal, and Process Development teams at Tempest.
- Management of external contract manufacturers and CROs, including:
-All activities related to drug product GMP batch manufacture
-Design and management of CQA and FMEA exercises, including late-stage process characterization
-Design and support of stability studies
-Drafting and providing input on contracts and agreements
- Support activities related to IP filings.
- Present updates and serve as the subject matter expert on drug product activities to internal and external collaborators.
- Author and review drug product modules for regulatory dossiers and other controlled documents.
- Ensure the drug product team is properly resourced and that all stakeholders are appropriately developed and supported to deliver on strategic plans.
Education, Experience & Qualifications:
- Ph.D. in an appropriate technical discipline with 7+ years of relevant industry experience or M.S./B.S. in corresponding fields with 12+ years.
- Prior experience working on the drug product development of oral small-molecule therapeutics in a GMP environment.
- Ability to troubleshoot and analyze data to solve technical problems related to manufacturing and product quality.
- Prior experience managing a formulation or drug product team internally or externally.
- Prior experience with late-stage process characterization activities.
- Ability to foster strong partnerships and effectively manage CMO and CRO activities abroad.
- Excellent written and oral communication capabilities.
- Desire to mentor and build collaborative and inclusive teams.
About Tempest Therapeutics:
Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule therapeutics to treat cancer through mechanisms that directly kill tumor cells and activate tumor-specific immunity. The company’s leadership is comprised of experienced oncology drug discovery and development professionals who share a common goal of advancing novel therapeutics that will bring meaningful benefit to patients.
Tempest is headquartered in Brisbane, CA and is publicly traded on the NASDAQ under the ticker symbol TPST. More information about Tempest can be found on the company’s website at www.tempesttx.com.
Tempest offers a competitive salary and benefits package and prides itself on being an awesome place to work. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender identity, sexual orientation, age, marital status, veteran status, or disability status.
We anticipate the base salary for the Associate Director/Director, Drug Product Process Development position in our Brisbane, CA office to range from $185,000 to $215,000 and will depend on current market data and the candidate’s qualifications for the role, including education and experience. The compensation described above is subject to change and could be higher or lower than the range described based on several factors.
Qualified candidates should forward a resume and cover letter to: careers@tempesttx.com
Please note, this is not a remote position. NO PHONE CALLS, RECRUITERS, or AGENCIES, please.
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