Director, Process Chemistry

Cortexyme

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Manufacturing
  • Post Date: 04/17/2021
  • Website: cortexyme.com
  • Company Address: 329 Oyster Point Blvd. #300 South San Francisco, South San Francisco, CA, 94080

About Cortexyme

Cortexyme is developing therapeutics based on data supporting a new theory of the cause of Alzheimer's and other degenerative disorders. Cortexyme is targeting a specific, undisclosed pathogen tied to neurodegeneration and beta amyloid production. The target has been validated in a number of animal models and Cortexyme is currently moving a proprietary small molecule towards human clinical testing.

Job Description

Position Purpose

Reporting to the Vice President of CMC, the Director, Process Chemistry will be responsible for the process development and supply of small molecule drug substance (API) for all phases of clinical development (process research, scale-up, and process validation) and commercial launch activities.  This role’s primary responsibility is to manage partner Contract Development Manufacturing Organizations (CDMOs) to ensure excellent manufacturing process development, technical transfer, validation and commercial manufacture of Cortexyme’s target Active Pharmaceutical Ingredients (APIs), and to drive continuous improvement, when appropriate. The Director will be an external partner-facing leader who personifies Cortexyme’s shared values and culture.   This scope of this role spans process design and development through manufacturing and regulatory submission.

Essential Responsibilities

  • Manage and lead external teams (CDMOs and CROs) to execute on Cortexyme’s efforts on chemical development, route optimization and scale-up to deliver non-GMP and GMP material in multi-kilogram quantities
  • Develop overall API strategy, timelines, budgets, risk & mitigation plans for all process development and manufacturing campaigns and related synthetic chemistry projects
  • Design phase-appropriate synthetic routes and implement regulatory control strategies for GMP manufacture
  • Act as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues, and for CRO/CDMO/CMO audits
  • Work with project teams to identify drug substance requirements, manage and optimize aggressive project timelines, oversee the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered
  • Author appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions
  • Represent Drug Substance Development in a cross-functional manner to provide assessments, evaluations, status, issues, and other relevant technical aspects of corresponding programs
  • Review, author and approve manufacturing process documentation such as process development protocols and reports, batch records, validation protocols and reports, specifications, etc.

Qualifications

  • Ph.D. with 10+ years industry experience in process chemistry in the biotechnology/pharmaceutical industry
  • Proven track record in developing and implementing robust and efficient drug substance manufacturing processes
  • Broad knowledge of regulatory and quality requirements for pharmaceutical products.
  • Effective troubleshooting and problem-solving skills
  • Excellent oral and written communication skills

Travel Requirements

  • May require approximately 10% travel

Cortexyme is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, protected veteran status, disability status or any other characteristic protected by law.

For more information on Cortexyme, visit www.cortexyme.com.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.