Associate Director, Chemical Development
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
The 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 ensure CMC activities are executed seamlessly and in alignment with the clinical development plans and timelines. The candidate will contribute to the overall CMC strategy, oversee planning, and execution; provide regulatory documentation for early phases of clinical trials; and participate in managing other CDMO areas, including analytical and drug product manufacturing.
This is a full-time permanent position based in South San Francisco, CA.
Responsibilities:
- Develop chemical processes for manufacturing small-molecule drug substances
- Lead process development and drug substance manufacturing activities at external labs and manufacturing facilities
- Manage and maintain project timelines for CMC activities in support of clinical development activities
- Contribute to develop target drug substance profile and specifications
- Screen and select external partners for process research, non-GMP and GMP production of drug substances
- Oversee tech transfer and process validation of drug substance manufacturing processes
- Design, review, and approve of study protocols, development reports, and manufacturing batch records, and manage master production records and specifications
- Review proposals, negotiate prices, recommend suppliers, verify delivery, manage contracts, and maintain necessary records
- Identify and facilitate procurement of raw materials needed for drug substance manufacturing activities
- Collaborate with cross-functional pre-clinical, clinical development, and clinical operations teams to ensure CMC and program goals are met
- Work closely with CMC Analytical, Formulations, Quality Assurance and Regulatory teams
- Author, review and approve relevant CMC sections for regulatory submissions
- Represent the CMC team to communicate CMC strategy and project status to key stakeholders cross-functionally and assist in driving decision-making
Requirements:
- Ph.D. degree in Chemistry, Chemical Engineering, or related scientific field
- 10+ years of industry experience in small-molecule drug substance chemical development and manufacturing
- Direct experience with management of CMOs in small-molecule drug substance manufacturing
- Thorough understanding and knowledge of industry practices in drug substance manufacturing and supply
- Strong knowledge of GMP regulations and compliance
- A proven track record in chemical process development from R&D to late-stage development
- Good understanding and knowledge of analytical methods and related issues
- Familiar with basic formulations is highly desirable
- Experience in writing CMC sections for regulatory submissions and documentation
- Strong organizational and planning skills, with ability to balance multiple deliverables and responsibilities
- Excellent written and verbal communication skills
- Ability to work collaboratively in a team environment with internal and external partners
-
Associate Director, Chemical Development
2 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
6 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, Chemical Development
3 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, 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 company’s pipeline compounds. The candidate will provide technical and organizational leadership and work closely with cross-functional stakeholders to...
-
Space Travel: Adaptive Research and Technologies from Biological and Chemical Engineering Conference
Found in: Jooble US O C2 - 2 weeks ago
San Francisco, CA, United States Chemical Full timeSpace Travel: Adaptive Research and Technologies from Biological and Chemical Engineering Conference November 19-20, 2020 | USA Space Travel: Adaptive Research and Technologies from Biological and Chemical Engineering Conference will focus on space travel technology and capability needs, in an effort to accelerate the development of commercial 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 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...
-
Associate Director, Formulation and Drug Delivery
Found in: Appcast US C2 - 7 days ago
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...
-
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: Appcast Linkedin GBL C2 - 2 weeks ago
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, 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...
-
Associate Director, CMC Analytical Development
Found in: beBee jobs US - 6 days 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...
-
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
4 days ago
South San Francisco, United States BioPhase Full timeAssociate Director$170-200K + bonus & equityResponsibilities:As the Associate Director you will play a pivotal role in establishing and expanding the company's capabilities for preclinical in vitro and clinical ex vivo disease pathobiology. Key responsibilities include:Designing and executing in vitro and ex vivo studies to advance therapeutic...
-
Associate Director
Found in: Appcast US C2 - 7 days ago
South San Francisco, United States BioPhase Full timeAssociate Director$170-200K + bonus & equityResponsibilities:As the Associate Director you will play a pivotal role in establishing and expanding the company's capabilities for preclinical in vitro and clinical ex vivo disease pathobiology. Key responsibilities include:Designing and executing in vitro and ex vivo studies to advance therapeutic...
-
Associate Director
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
South San Francisco, United States BioPhase Full timeAssociate Director$170-200K + bonus & equityResponsibilities:As the Associate Director you will play a pivotal role in establishing and expanding the company's capabilities for preclinical in vitro and clinical ex vivo disease pathobiology. Key responsibilities include:Designing and executing in vitro and ex vivo studies to advance therapeutic...
-
Associate Director
6 days ago
South San Francisco, United States BioPhase Full timeAssociate Director $170-200K + bonus & equity Responsibilities: As the Associate Director you will play a pivotal role in establishing and expanding the company's capabilities for preclinical in vitro and clinical ex vivo disease pathobiology. Key responsibilities include: Designing and executing in vitro and ex vivo studies to advance therapeutic programs....
-
Associate Director
3 days ago
South San Francisco, United States BioPhase Full timeAssociate Director $170-200K + bonus & equity Responsibilities: As the Associate Director you will play a pivotal role in establishing and expanding the company's capabilities for preclinical in vitro and clinical ex vivo disease pathobiology. Key responsibilities include: Designing and executing in vitro and ex vivo studies to advance therapeutic programs....
-
Associate Director, Web Strategy and Development
Found in: Jooble US O C2 - 2 weeks ago
San Francisco, CA, United States Peacefestival Full timeAssociate Director, Web Strategy and Development Opportunities for Associate Director, Web Strategy and Development in San Francisco, CA Remote positions only Search completed. Found 0 matching records. #J-18808-Ljbffr
