Sr. Manager/Associate Director, CMC Analytical Development
3 weeks ago
Description:
Location: San Diego, CA 92121
Position type: Full time
Job Code: KB-CMC-XX
Required education: Ph.D. Degree (preferred) /Master's Degree
Area(s) of expertise desired: Analytical chemistry or related field
Description
Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founder to translate innovative research to novel therapeutics. Our team has a proven track record of drug discovery and development, having played pivotal roles in the discovery of multiple clinical-stage compounds as well as an approved drug for the treatment of cancers and immune-mediated inflammatory diseases.
We are currently seeking a highly motivated, creative CMC analytical professional at associate director level to join our CMC team in San Diego. This candidate will report to the Director of Analytical Development. This candidate is expected to work closely with the Kumquat internal discovery and development teams as well as external CRO/CDMO companies to drive programs into early and late clinical development. This is a position with responsibility for analytical method development and validation, batch release, and stability study. The ideal candidate will have an in-depth understanding in all aspects of analytical support for the development of small molecule drug substances and drug products. A strong team player who is detail-oriented and has the desire to learn and understand life-cycle product management concepts and practice is essential. The candidate will have the opportunity to work on multiple programs within the company's pipeline which comprises potentially first-in class approaches & novel-novel targets.
Role Responsibilities
* Serve as the analytical lead for assigned projects to oversee all analytical development activities at CDMOs to ensure the quality of products according to the project needs and the stage of development.
* Oversee/coordinate with CDMOs to ensure phase-appropriate methods (RSM, IPC, DS, DP) are developed and validated ahead of batch manufacturing and testing.
* Define phase-appropriate quality control strategies, specifications, stability studies, and assign retest date/shelf life for drug substances and drug products.
* Serve as the point of contact for investigations, technical issues, and other product development activities.
* Author/review relevant CMC sections for regulatory submissions and respond to agency requests.
* Perform overall review of data generated on development and clinical supply samples.
* Present to cross-functional teams and effectively communicate critical issues and solutions to staff at all levels within the organization.
Requirements:
* A PhD or MS in Analytical Chemistry or related field with 8+ years (PhD) or 12+ years (MS) relevant experience in a pharmaceutical analytical environment focusing on small molecule drugs.
* Strong knowledge of cGMP and Regulatory guidelines is a necessity. Prior experience in drafting regulatory dossiers (IND and IMPD) is highly desired.
* Experience with phase-appropriate analytical method development, validation, release testing and stability study for solid dosage form and injectable drug products.
* In-depth knowledge with various analytical techniques such as HPLC, GC, LC-MS, dissolution, XRPD and particle size analysis.
* Ability to work in a fast-paced environment, manage priorities, and maintain timelines for multiple projects is critical.
* Motivated to take initiative, solve problems, and committed to teamwork within the CMC group and with CDMO teams.
Kumquat Biosciences offers an attractive salary and benefits package, including equity incentives.
-
San Diego, United States Shelby American Inc Full timeDescription Location: San Diego, CA 92121 Position type: Full time Job Code: KB-CMC-XX Required education: Ph.D. Degree (preferred) /Master’s Degree Area(s) of expertise desired: Analytical chemistry or related field Description Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat...
-
San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Location: San Diego, CA 92121Position type: Full timeJob Code: KB-CMC-XXRequired education: Ph.D. Degree (preferred) /Master’s DegreeArea(s) of expertise desired: Analytical chemistry or related fieldDescriptionKumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer...
-
San Diego, CA, United States Shelby American, Inc. Full timeDescription Location: San Diego, CA 92121 Position type: Full time Job Code: KB-CMC-XX Required education: Ph.D. Degree (preferred) /Master’s Degree Area(s) of expertise desired: Analytical chemistry or related field Description Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments....
-
San Diego, CA, United States Kumquat Biosciences Full timeDescription: Location: San Diego, CA 92121 Position type: Full time Job Code: KB-CMC-XX Required education: Ph.D. Degree (preferred) /Master's Degree Area(s) of expertise desired: Analytical chemistry or related field Description Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments....
-
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...
-
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...
-
Associate Director, CMC Analytical Development
2 months 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
4 weeks ago
South San Francisco, United States BioSpace Full timeJob DetailsAlumis 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...
-
Associate Director, CMC Analytical Development
1 month ago
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...
-
Director Biologics API Chemical Development CMC
4 weeks ago
San Diego, United States Clinical Dynamix, Inc. Full timeAbout the Role:Seeking a highly motivated and talented biologics leader within CMC (antibodies, gene therapy) in the areas of upstream and downstream API development, optimization and manufacture. The successful candidate will work on research and development of biologics processes and regulatory document contribution internally and will also perform and...
-
Director/Sr. Director
1 month ago
San Jose, CA, United States Meet Recruitment Limited Full timeMy client is a clinical-stage biopharmaceutical company focused on developing innovative therapies for rare diseases. They are currently seeking a skilled regulatory professional to join their growing team as Director/ Sr. Director CMC Regulatory Affairs. This role will involve hands-on development and implementation of regulatory strategies for CMC aspects...
-
San Diego, United States Kumquat Biosciences Inc Full timeJob DescriptionJob DescriptionDescription:Kumquat Biosciences is committed to the discovery and development of innovative drugs to transform cancer treatments. Kumquat brings together an accomplished management team and distinguished scientific founders to translate innovative research to novel therapeutics. Our team has a proven track record of drug...
-
San Francisco, CA, United States Barrington James Full timeDirector/Senior Director of Analytical Development (CA, hybrid or remote with frequent travel) I've got a great opportunity to join a pioneering biotech company at the forefront of innovative biologics development, specializing in antibodies for infectious and rare diseases. They are committed to revolutionizing treatments and improving patient...
-
Scientist, CMC Analytical Development
1 month 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 Alumis team is seeking a highly motivated Contract...
-
Scientist, CMC Analytical Development
1 day 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 Alumis team is seeking a highly motivated Contract...
-
Scientist, CMC Analytical Development
1 month 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 Alumis team is seeking a highly motivated...
-
San Diego, United States VENTYX BIOSCIENCES, INC. Full timeDescription Ventyx Biosciences, Inc. is a clinical-stage, public biopharmaceutical company focused on advancing new therapies for millions of people living with inflammatory diseases and autoimmune disorders. We are developing novel and differentiated therapeutics that target both the innate and adaptive immune system. Our clinical-stage programs include an...
-
Scientist, CMC Analytical Development
2 days 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 Alumis team is seeking a highly motivated...
-
San Francisco, CA, United States Dennis Partners Full timeThis clinical-stage biotechnology company is developing potentially curative therapies for heart disease. They are seeking a Regulatory CMC Executive Director or Senior Director to lead CMC Regulatory strategies and execution for their portfolio of programs. Reporting into the SVP of Regulatory, you will lead CMC submissions and work directly with health...
-
Scientist, CMC Analytical Development
1 month ago
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 Alumis team...
