CMC Project Manager

Cortexyme

South San Francisco, CA, US
  • Job Type: Full-Time
  • Function: Engineering Prod Mgmt/Dev
  • Post Date: 02/12/2021
  • 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

Cortexyme, Inc. seeks a CMC Project Manager who will be responsible for coordinating the following:  change controls, SOPs, and purchase orders. Maintain project planning and budgeting for manufacturing activities associated with product development, chemical development and commercialization. The successful candidate will have a firm understanding of manufacturing and its associated cGMP quality systems. This role will provide both tactical and strategic support for the manufacturing team. In addition, the CMC Project Manager will support tracking and trending of manufacturing metrics and develop manufacturing SOPs as needed.  The CMC Project Manager will also work closely with Quality, Regulatory Affairs, Finance and other key external parties.  Reports to the Senior Director, Technical Operations.

Responsibilities

  • Ensure timelines (action items/pending issues) and budget are on track using established or developing project management tools.
  • Initiate/support independent projects that may be relevant to product manufacturing, chemical development, and serialization efforts.
  • Maintain product development filing structure for final documents and reports to support pre-approval inspections.
  • Support Purchase Order tracking activities from gathering the executed quotes or SOW’s, issuance of the purchase order and monitoring acceptance of the services or materials requested.
  • Support budgeting activities associated with product development, chemical development and commercialization.
  • Coordinate with Manufacturing, Regulatory Affairs and Quality to facilitate internal change control requests.
  • Support shipping of samples, standards and markers to external stakeholders.
  • Coordinate with the management team to ensure manufacturing processes are properly documented, reviewed, and approved prior to implementation.
  • Authoring and subsequent maintenance of product specification documents including revisions of SOPs, as needed.
  • Expected to think critically and see gaps in products or processes, show initiative and good judgment in developing solutions.
  • Help build a strong manufacturing system infrastructure so that the team may benefit from its efficiencies.
  • Use PowerPoint, MS Project, or Excel to create concise presentations for team on status of project.
  • Execute on project plans, management of team’s project budgets, and clear and efficient communication of project status and issues to all stakeholders.
  • Maintain financial records for project work, raising invoices as required.
  • Build and maintain production related inventory tracking.
  • Provide support to the pharmaceutical sciences group as related to change controls, product specifications, SOPs, project quote requests, budget tracking and manufacturing systems.
  • Build timelines, work breakdown structures, follow up with individuals on the completion of their tasks.
  • Proactively work with members of the pharmaceutical sciences group to support project deliverables and activities.

Requirements

  • A minimum BS/BA degree, or equivalent, in science or related field of study
  • 5+ years of relevant work experience in Pharmaceutical Manufacturing and/or QA and/or Project Management
  • Working knowledge of cGMP regulations and ICH and CDER guidelines applicable to the development and production of investigational and commercial drug products.
  • Strong working knowledge of project management and budgeting activities
  • Direct knowledge of manufacturing processes and validation requirements, a plus.
  • Strong organizational skills and ability to coordinate and advance multiple project timelines, simultaneously.
  • Strong experience in preparing and reviewing technical documentation.
  • Ability to effectively support and participate on multi-disciplinary program teams.
  • Strong interpersonal skills and excellent oral and written communication skills.

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.