Carmot Therapeutics, Inc. is an ambitious undertaking, and we fully expect our company to become a dominant force in the development and commercialization of novel pharmaceutical drugs addressing large unmet needs. To support this vision, we are looking for a hand on and tactically focused scientist level small molecule analytical chemist who will work closely with CMOs, CROs and internal stakeholders to support starting materials, intermediates, drug substances, and drug products efforts. The position will report to the Director of Analytical Development.

At Carmot, we do not believe in silos, and we work highly efficiently as a small team. Hence, the ideal candidate would be an excellent communicator with strong orientation to detail, and with proven collaboration skills and ability to work across functions to produce results in a timely manner. In addition, the candidate must be self-motivated with a problem-solving (e.g. “how can I help solve this problem for you”) attitude, given the highly dynamic nature of clinical development and rapid tactical changes anticipated in a small biotech company with large ambitions. As such, the role will have a direct impact on the successful execution of our CMC timelines, and therefore can have a significant impact on the company’s trajectory.

Responsibilities:

• Provide technical leadership for small molecule analytical activities, including specification setting, test method development and qualification, and outsourced QC testing for drug substance and drug product.
• Lead cross-functional collaborations to establish phase-appropriate specifications and analytical control strategies for starting materials, intermediates, drug substances, and drug products.
• Performs laboratory work related to analytical testing and method development in support of CMOs.
• Lead the characterization of starting materials, drug substances, drug product process and product-related impurities.
• Provide technical leadership for development, and phase-appropriate validation of critical test methodologies, including assay, purity and impurities, organic volatile impurities, dissolution, etc.
• Manage day-to-day analytical development and testing activities at CMOs and contract test labs to assure that projects remain on-track.
• Communicate and present analytical data in CMC meetings and other cross-functional settings.
• Author and review CMC analytical sections in INDs and other regulatory filings.
• Collaborate effectively with internal and external stakeholders to deliver program objectives.
• Review data for technical content and regulatory compliance.

Key Qualifications:
• M.S. or PhD in analytical chemistry or related field
• 7 years of experience with M.S. and 3 years with PhD in CMC analytical development
• In-depth expertise in test method development, method qualification/transfer, and characterization of different phase small-molecule drugs.
• Chiral HPLC method development (Kiral – small molecule drugs and qualification experience)
• Broad analytics expertise with widely employed techniques – HPLC (UV, RID, ELSD, CAD), GC, MS, NMR, XRPD, DSC/TGA, KF, particle size analysis, ICP-MS, IC and dissolution
• Knowledgeable of compendial test methods (USP/EP) used for DS and DP testing
• Strong working knowledge of GLP, cGMP, and ICH requirements
• Problem-solving and troubleshooting skills
• Demonstrated leadership, planning and organizational skills
• Extensive experience providing technical leadership to CDMOs and contract test lab partners
• Experience with working cross-functionally among project teams, including internal groups and external CMOs
• Exceptional oral and written communication skills geared to all levels of the organization
• Must be authorized to work for any employer in the U.S. without visa sponsorship
This position is hybrid in Berkeley, CA. Local candidates preferred

Carmot offers a competitive salary, participation in our stock option plan, 401K retirement with company contribution and comprehensive benefits.

Carmot Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding and related medical conditions), and sexual orientation.