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Director, CMC Product Lead

Company: MannKind Corporation
Location: Danbury
Posted on: September 23, 2022

Job Description:

At MannKind our employees are our number one asset, and we continue becoming a tight-knit community where each of us plays a critical role in our collective success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better. Position Summary: The Director CMC Product Lead will have responsibility for leading one or multiple product technical development teams. The candidate will be the product quality CMC expert and accountable for end-to-end oversight of MannKind's pipeline programs(s) throughout clinical development, commercialization, filing, approval, launch, and post approval lifecycle management. The candidate should have a good understanding of drug development and commercialization and be able to partner and work effectively with other functions to enable a robust product development (QbD) approach that takes into account technical, regulatory, and quality / compliance considerations. Given global organization and multiple partnerships (CMO, CRO), the candidate is expected to support the team with a business and project management framework, facilitate the information exchange across the CMC functions, collaborate with Regulatory Affairs in the coordination of the CMC input to Filing Documents. The candidate will also provide direction for the execution of supporting functional tactical plans and prepares the project update for management reviews. The position will be based in Danbury, CT, and reports into the Executive Director Clinical Product Development.

  • Project Leadership; ensure effective communication of deliverables up and across the organization
  • Drive execution according to the CMC product strategy and plans activities to deliver the CMC strategy for the program
  • Execute Risk Assessments and ensure timely communication and escalation
  • Champion Critical Quality Attributes and Critical Process Parameters across the portfolio and specific to therapeutic areas in support of IND and BLA filings
  • Authors Module 3 CMC for regulatory filings
  • Critically review and approve relevant documents, including but not limited to all CMC regulatory submissions, briefing booklets, information requests, etc.
  • Collaborate with other functions to plan testing, stability strategy/program, and participates and supports deviations & investigations
  • Actively monitors product metrics, data, stability & initiate improvements
  • Consolidating and updating CMC project timelines and alignment with overall project development plan; build the CMC project budget based on functional input Minimum qualifications to perform the job; specific skills, education, knowledge and job experience necessary to perform essential duties:
    • Advanced degree in chemistry, biochemistry, biology, or a related biotechnology sciences field
    • Minimum of 10-15 years of experience in the Biotechnology or Pharmaceutical Industry, preferably in quality, analytical development, process development, regulatory, or manufacturing
    • Experience with authoring or review of regulatory filing or similar regulatory documentation
    • Experience with setting up phase-appropriate analytical control strategies
    • Experience supporting non-conformance investigations, authoring, reviewing, and defending critical product impacting non-conformances
    • Good knowledge of GMP principles, ICH guidelines, FDA/EMEA guidance on orally inhaled products as well as the pharmacopeia
    • Knowledge of formulation for orally inhaled products and process development
    • Experience / knowledge of Quality by Design, Risk Assessment, Design of Experiment or Data Analysis are a strong plus
    • Ability to think strategically and creatively along with excellent presentation, communication, and interpersonal skills
    • Proven track record as team leader, preferably of global teams with strong communication skills even in a semi-virtual environment
    • Knowledge of product transfers to CMOs and/or method transfers to CROs ideally across all stages from early to commercial
    • Pro-active collaborator and communicator, service and customer oriented with a holistic understanding of drug development -

Keywords: MannKind Corporation, Danbury , Director, CMC Product Lead, Executive , Danbury, Connecticut

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