Associate Director, Formulation and Drug Delivery
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
Our client is a clinical stage biopharmaceutical company dedicated to improving patients’ lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms.
Title: Associate Director, Formulation and Drug Delivery
Location: South San Francisco, California
Salary: $175k - 215k
Position Summary:
We are seeking an experienced and highly motivated small molecule formulation scientist with a proven record of sustained laboratory achievement and innovation to join our growing Department of Pharmaceutical Sciences (PharmSci/CMC). The successful candidate will report to the Director of Formulation and Drug Delivery and will be responsible for:
- Accountable for the design, development, and characterization of phase appropriate solid oral dose drug product formulations, packaging, and manufacturing processes to successfully support clinical studies.
- Leading the cGMP drug product manufacturing and packaging activities at CMOs and oversight in close partnership with quality.
- Lead late-stage drug product development activities including scale-up, design of experiments (DOEs), risk assessments, and development of the integrated control strategy in partnership with other CMC functional areas, Quality, Regulatory Affairs, and Manufacturing.
- Leading the developability assessment of new candidates, preclinical formulation, preformulation, and discovery pharmaceutics studies including API form selection and characterization to nominate a suitable form for development, troubleshooting, and ‘defining the path’ for new drug candidates.
- Authoring CMC sections of regulatory filings and participating in regulatory agency interactions.
Requirements
- Ph.D. or M.S. in Chemical Engineering or relevant scientific discipline with at least 10 years of experience in formulation and drug product development and track record of progressing assets from INDs to MAAs.
- Strong understanding and extensive hands‐on experience in early- and late-stage drug product process development. In-depth understanding of formulation development best practices & trends.
- Proven experience in the generation of relevant regulatory sections of IND filings.
- Excellent problem-solving and decision-making skills with the ability to quickly adapt to changing program needs
-
South San Francisco, United States Astrix Inc Full timeOur client is a clinical stage biopharmaceutical company dedicated to improving patients’ lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. Title: Associate Director, Formulation and Drug Delivery Location: South San Francisco, California Salary: $175k - 215k Position Summary: We are seeking an experienced...
-
South San Francisco, United States Astrix Inc Full timeOur client is a clinical stage biopharmaceutical company dedicated to improving patients lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. Title: Associate Director, Formulation and Drug Delivery Location: South San Francisco, California Salary: $175k - 215k Position Summary: We are seeking an experienced and...
-
South San Francisco, United States Astrix Inc Full timeOur client is a clinical stage biopharmaceutical company dedicated to improving patients lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms. Title: Associate Director, Formulation and Drug Delivery Location: South San Francisco, California Salary: $175k - 215k Position Summary: We are seeking an experienced...
-
South San Francisco, United States Astrix Full timeOur client is a clinical stage biopharmaceutical company dedicated to improving patients’ lives. They develop multiple precision medicines targeting hallmark cancer resistance mechanisms.Title: Associate Director, Formulation and Drug DeliveryLocation: South San Francisco, California Salary: $175k - 215kPosition Summary:We are seeking an experienced and...
-
Associate Director, Formulation and Drug Delivery
Found in: Jooble US O C2 - 1 week ago
San Francisco, CA, United States Oric Pharmaceuticals, Inc. Full timeORIC is a research-driven company dedicated to discovering and developing novel therapies that can Overcome Resistance In Cancer. Our collaborative, empowering culture gives scientists the authority, responsibility, and support to do cutting-edge work on therapies for treatment-resistant cancers. We are seeking an experienced and highly motivated small...
-
Associate Director, Chemical Development
4 days ago
South San Francisco, United States Enigma Search Full timeThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Associate Director, Chemical Development
1 hour ago
South San Francisco, United States Enigma Search Full timeThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Associate Director, Chemical Development
Found in: Appcast US C2 - 1 week ago
South San Francisco, United States Enigma Search Full timeThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Associate Director, Chemical Development
1 week ago
South San Francisco, United States Enigma Search Full timeThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Associate Director, Chemical Development
5 days ago
South San Francisco, United States Enigma Search Full timeThe Associate Director of CMC, reporting to the Sr. VP of Chemistry, is primarily responsible for the development and manufacture of small-molecule drug substances in support of clinical development of the companys pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Associate Director, CMC Analytical Development
Found in: beBee S US - 2 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...
-
Senior Director, Late-Stage Drug Product Development
Found in: Jooble US O C2 - 3 days ago
San Francisco, CA, United States SciPro Full timeAn exciting SF-based biotech is hiring for a Senior Director of Drug Product Development (Late-Stage). In this role, you will have the opportunity to: - Lead formulation development strategy from preformulation through commercialization and life cycle management - Lead late-stage manufacturing for small molecule drug product development - Lead all DP...
-
Associate Director, CMC Analytical Development
Found in: beBee jobs US - 1 week ago
South San Francisco, California, 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...
-
South San Francisco, United States Alumis Full timeJob DescriptionJob DescriptionSalary: Alumis 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...
-
ASSOCIATE DIRECTOR, CHEMICAL DEVELOPMENT/DRUG SUBSTANCE MANUFACTURING
Found in: Careerbuilder One Red US C2 - 7 hours ago
South San Francisco, CA 94080, USA, United States Cytokinetics, Incorporated Full timeCytokinetics is a late-stage, specialty cardiovascular 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 cardiac muscle performance is compromised. As a leader in muscle biology and the mechanics of...
-
Associate Director, Clinical Supply Chain
3 days ago
South San Francisco, United States DSJ Global Full timeAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development stages of our antibody-based...
-
Associate Director, Clinical Supply Chain
4 days ago
South San Francisco, United States DSJ Global Full timeAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development stages of our...
-
Associate Director, Clinical Supply Chain
Found in: Appcast US C2 - 6 days ago
South San Francisco, United States DSJ Global Full timeAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development stages of our antibody-based...
-
Associate Director, Clinical Supply Chain
Found in: Appcast Linkedin GBL C2 - 6 days ago
South San Francisco, United States DSJ Global Full timeAbout: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the development stages of our antibody-based...
-
Associate Director, Clinical Supply Chain
10 minutes ago
South San Francisco, United States DSJ Global Full time2-3 days onsite in SF REQUIRED About: We are currently looking for an Associate Director of Supply Chain to oversee the supply chain operations for our innovative clinical programs. This role entails establishing and managing supply and demand planning processes, coordinating clinical orders, and ensuring smooth logistics management throughout the...
