- 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.
- 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.
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Sr. Manager/Associate Director, CMC Analytical Development - San Diego, United States - Shelby American Inc
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#J-18808-Ljbffr
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