Director, Drug Product Development
4 weeks ago
Position Summary:
Terremoto Biosciences is located in South San Francisco and is seeking a Director responsible for formulation development and drug product manufacturing within the CMC group. Reporting to the Head of CMC, the incumbent will be required to work flexibly across multiple small molecule programs with responsibilities including but not limited to managing formulation development strategies across various stages of development, overseeing manufacturing activities at trusted CDMO partners, and ensuring an uninterrupted supply of bulk drug product.
Key Responsibilities:
* Act as the drug product technical lead for multiple small molecule programs
* Develop strategies and oversee the execution of activities associated with drug product development and manufacturing, supporting clinical development, and regulatory filings
* Provide technical leadership while working with cross-functional team members
* Lead pre-formulation, final form selection, formulation and process development, clinical manufacturing, scale-up, tech transfer, and process optimization activities related to solid oral dosage forms
* Travel to CDMOs for vendor assessment, qualification, and/or manufacturing oversight as needed
* Effectively communicate both written and verbally all drug product related activities to key stakeholders
* Author development reports, compile documentation, and draft sections for regulatory submissions
Professional Experience/Qualifications:
* Ph.D. in Pharmaceutical Sciences or related field with 8+ years of experience in the pharmaceutical/biotech industry with a strong track record of technical expertise, leadership, and drug product development experience across various stages of development with small molecules
* Direct experience with the management of CDMOs
* Thorough understanding and working experience of pharmaceutical drug products concerning cGMP, quality systems, ICH guidelines, FDA, EMA, and associated regulatory requirements
* Strong understanding of the drug development process from preclinical through late-stage development
* Strong organizational skills with the ability to effectively manage multiple priorities and clearly communicate results both written and verbally
* The anticipated salary range for candidates who will work in South San Francisco, CA is $220,000 to $235,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Terremoto Biosciences, is a multi-state employer and this salary range may not reflect positions that work only in other states.
We are an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
-
South San Francisco, California, United States IDEAYA Biosciences Full timeWe are seeking an experienced and highly motivated Director/Senior Director, Drug Product/Formulation Development who will report to the VP of CMC. This individual will drive the drug product development and strategy including pre-formulation, formulation, scale-up and manufacture for all our preclinical and clinical projects. The scope spans the development...
-
South San Francisco, California, United States IDEAYA Biosciences Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with...
-
South San Francisco, United States BioSpace Full timeJob DetailsIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational...
-
San Francisco, California, United States IDEAYA Biosciences, Inc. Full timeIDEAYA Biosciences is a public biotech company focused on precision medicine oncology. At IDEAYA, brilliant minds collaborate to develop targeted therapies for cancer patients. The company's approach involves advanced capabilities in identifying biomarkers and drug discovery, aiming to deliver the right medicine to the right patient for an effective clinical...
-
San Francisco, United States IDEAYA Biosciences, Inc. Full timeIDEAYA Biosciences (NASDAQ: IDYA) is a public, clinical-stage precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using DNA sequencing and other molecular diagnostics. Our approach integrates extensive capabilities in identifying and validating translational biomarkers with...
-
Director, Drug Product Development
1 week ago
South San Francisco, United States Terremotobio Full timeWhile the Terremoto team is driven to unlock the power of covalent chemistry, we strive to explore new landscapes and support each other along the way. See what its like to be one of the Terremoto Earth-Shakers. Our Mission Delivering Medicines with Superior Therapeutic Benefit By broadening the covalent drug universe with lysine-targeted chemistry, it...
-
Director, Drug Product Engineering
1 week ago
San Mateo, United States Vaxcyte Inc Full timeJob DescriptionJob DescriptionCompany Profile:Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know...
-
Director, Drug Product Engineering
4 weeks ago
San Mateo, United States Vaxcyte Inc Full timeJob DescriptionJob DescriptionCompany Profile:Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know...
-
Associate Director, Formulation Development
4 weeks ago
South San Francisco, United States Pliant Therapeutics, Inc. Full timePliant is conducting a Phase 1 study for its third clinical program, PLN-101095, a small molecule, dual-selective inhibitor of αvß8 and αvß1 integrins, that is being developed for the treatment of solid tumors. The Company also has discovery and development programs in oncology and muscular dystrophies. **Description**: The Associate Director,...
-
Director, Process Chemistry
4 weeks ago
South San Francisco, United States Vistagen Full timeABOUT THIS ROLE: The Director, Process Chemistry, Drug Substance (CMC) will serve as a technical subject matter expert responsible for drug substance process development from clinical development through commercialization. The successful candidate needs to demonstrate a proven track record of working in a remote virtual environment with contract development...
-
Director, Drug Safety Operations
4 weeks ago
South San Francisco, United States Kaztronix Full timeA late-stage biopharmaceutical company focused on discovering, developing, and commercializing first-in-class muscle activators and next-in-class muscle inhibitors as potential treatments for debilitating diseases in which muscle performance is compromised and/or declining. As a leader in muscle biology and the mechanics of muscle performance, the company is...
-
Assoc Director or Director, Process Development
4 weeks ago
South San Francisco, United States Erasca, Inc. Full timeErasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide....
-
South San Francisco, United States Erasca, Inc. Full timeErasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide....
-
South San Francisco, United States Erasca, Inc. Full timePositionSummary: Reporting to the Executive Director, Process Development and Manufacturing, the Associate Director or Director, Process Development and Manufacturing is responsible for the design and execution of experiments to support process development and provides technical oversight of contract development and manufacturing organizations (CDMOs) for...
-
Assoc Director or Director, Process Development
4 weeks ago
South San Francisco, United States Erasca, Inc. Full timeErasca is a clinical-stage precision oncology company focused on discovering, developing and commercializing medicines for the benefit of patients with cancer. Our programs take novel approaches to shutting down one of cancer's most commonly mutated signaling cascades, the RAS/MAPK pathway, which affects approximately 5.5 million lives each year worldwide....
-
Medical Director, Global Drug Safety
2 weeks ago
South San Francisco, California, United States Denali Therapeutics Full timeDenali Therapeutics is dedicated to developing breakthrough therapies for neurodegenerative diseases through our deep commitment to degeneration biology and principles of translational medicine.The OpportunityIn anticipation of the Company's growth plans, Denali Therapeutics is looking for a Medical Director, Global Drug Safety. This role will work on...
-
Director, Drug Substance Process Sciences
3 weeks ago
South San Francisco, United States CareerBuilder Full timeAbout Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline of...
-
Director, Drug Substance Process Sciences
4 weeks ago
South San Francisco, United States Allogene Therapeutics Full timeJob Description About Allogene: Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is...
-
Associate Director, CMC Analytical Development
4 weeks ago
South San Francisco, United States Alumis Inc. Full timeAlumis is a precision medicines company with the mission to transform the lives of patients with autoimmune diseases. Even with treatment innovations of the last two decades, many patients with immunologic conditions continue to suffer - our goal is to fundamentally change the outcomes for these patients. The small molecule CMC team is seeking a highly...
-
Director, Drug Substance Process Sciences
5 days ago
South San Francisco, United States Allogene Therapeutics Full timeAbout Allogene:Allogene Therapeutics, with headquarters in South San Francisco, is a clinical-stage biotechnology company pioneering the development of allogeneic chimeric antigen receptor T cell (AlloCAR T™) products for cancer and autoimmune disease. Led by a management team with significant experience in cell therapy, Allogene is developing a pipeline...
