13 days old

Associate Director, CMC

Venatorx Pharmaceuticals, Inc
Malvern, PA 19355
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  • Job Code
    128457820
Venatorx Pharmaceuticals, Inc

Full Time
Mgr & Dir - R&D/Ops
ArborRidge, Malvern, PA, US

The Associate Director, CMC shall be responsible for planning and execution of drug substance and related CMC development activities, to support progression of clinical and preclinical candidates. The Associate Director, CMC will collaborate with Venatorx project team members, external consultants, and contract service providers to define the drug substance manufacturing process and control strategy.

Responsibilities include:
  • Manage collaboration with contract service providers on drug substance development activities, including but not limited to process development, polymorph screening/phase selection, physical property attribute definition, identification and synthesis of process related impurities and degradation products, assessment of genotoxicity potential.
  • Review and approve process development reports and ensure that these are adequate to support regulatory filing.
  • Provide technical oversight on manufacturing batch record review.
  • Manage reference standard inventory and distribution.
  • Identify drug substance critical quality attributes impacting safety, efficacy, and manufacturing robustness. Establish phase appropriate regulatory specifications.
  • Identify opportunities to optimize the drug substance manufacturing process, focusing on patient safety/efficacy and process economics.
  • Author drug substance CTD modules to support regulatory submissions (IND through NDA). Respond to questions from regulatory authorities.
  • Author drug substance background information to facilitate productive discussions with regulatory authorities.
  • Author appropriate sections of patents and applications
  • Develop and maintain a comprehensive understanding of regulatory guidance pertaining to drug substance development and commercialization.
  • Collaborate with project teams to meet project objectives, budget, and timelines.


Qualifications:
  • Ph.D. preferred, in Organic Chemistry, Chemical Engineering or related Chemistry or Engineering field with 5+ years of drug substance development experience, or M.S. with 7+ years of relevant drug substance development experience, or B.S. with 10+ years of relevant drug substance development experience.
  • Minimum of 5 years of progressively responsible experience in biopharmaceutical-based cGMP manufacturing operations in a pharmaceutical, biotechnology, CMO or related environment.
  • CMC development experience including manufacturing, stability batches, and process validation for Drug Substance (API) and Drug Product.
  • Experience in materials and vendor management, from planning through purchasing, negotiation, and administration of multi-million-dollar procurement agreements.
  • Experience and success preparing CMC regulatory filings, including Investigational New Drug Applications (IND), and New Drug Applications (NDA).
  • Ability to manage and direct projects and multi-disciplinary teams comprised of internal and external parties teams and adjust to changing priorities.
  • Strong organizational and communication skills.
  • Strong MS-Office skills.
  • Self-starter and a team player that will thrive in an entrepreneurial environment.


Equal Employment Opportunity/M/F/disability/protected veteran status



PI128457820
Posted: 2021-01-08 Expires: 2021-02-09

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Associate Director, CMC

Venatorx Pharmaceuticals, Inc
Malvern, PA 19355

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