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Scientist/Manager CMC Analytical at Crinetics Pharmaceuticals
San Diego, CA, US

Crinetics Pharmaceuticals is seeking a highly motivated professional to perform CMC analytical functions for API and drug product, joining its growing and dynamic team. This job will report to the Associate Director of CMC Analytical and will be managing the activities related to the release and stability of APIs, DPs, intermediates and reference standards as well as support for all other analytical related activities. This individual will be an integral part of the company’s effort to discover and develop small molecule therapeutics for rare endocrine disorders and endocrine-related tumors. This is a unique opportunity to work with a proven and well-funded drug discovery and development team in a small company environment in the heart of San Diego’s biotechnology community.

Responsibilities

These may include but are not limited to:

  • Monitoring all stability schedules, data and reports for API, DP, intermediates and reference standards
  • Review various analytical documentation related to API, pre-formulation, and DP
  • Direct methods development, qualification, transfer, and validation at external parties
  • Develop relationships with external parties (CROs, CMOs, RM suppliers, consultants, etc.) and actively manage and oversee these external parties. Evaluate and recommend external parties for analytical needs in API and drug product development to management
  • Write, review and manage request for proposal, statement of work, contract, budget and timelines
  • Support regulatory filings (including INDs, IMPDs, NDAs, briefing packages and other regulatory dossier)
  • Author and review department related Standard Operating Procedures, analytical methods, technical reports, specifications, corrective/preventative actions, change controls, investigations, and deviations, to ensure compliance with cGMP’s and company standards
  • Understand cross-functional needs in analytical API and drug product development and provide appropriate support to management as necessary
  • Ability to work in a laboratory performing methods development and troubleshooting existing methods for API and drug product
  • Stay current on industry trends, practices and regulatory guidances
  • Provide presentations and updates as necessary to management
  • Other tasks as assigned

Minimum Qualifications

  • A bachelors or masters degree in analytical chemistry or related field with at least 5 years of related technical experience
  • Previous industry experience in a biotech or pharma company is preferred
  • Well versed in reviewing and analyzing release and stability data for trending, shelf-life and specification determination. Experience with SLIM software is desired
  • Direct work experience in analytical laboratory activities such as testing, method development and qualification/validation in both API and DP is a required in a cGMP environment
  • Understanding of cGLP and cGMP requirements and, compendia testing, ICH and regulatory guidances is highly preferred
  • Prior experience managing third parties, domestic and international external service providers
  • A thorough understanding of analytical chemistry, solid form science and global stability requirements is desired
  • Excellent writing skills as they relate to preparation of analytical methods development/validation and transfer protocols and reports. Preparation of regulatory documents is desired
  • Excellent interpersonal skills with strong oral/written communication and presentation skills
  • Well versed with the latest trends in analytical technologies and the outsourcing industry

Travel

Travel may be required up to 20% of your time