POSITION OBJECTIVE: Manage, in whole and/or in part, multiple concurrent CMC-related projects. Projects may include pre-formulation and formulation development (for toxicology, clinical and/or commercial use), manufacturing process development, cGMP drug product manufacturing campaigns, analytical method development and validation, ICH-compliant stability studies, and clinical packaging, labeling, and distribution.

Essential Job Functions/Responsibilities

·      Manage the manufacturing of clinical phase and pre-launch commercial drug supplies through internal or external CDMO partners.

·      Participate as part of the CMC team in development and improvement of manufacturing processes related to clinical and commercial drug supplies.

·      Perform CDMO contract-related activities (issuance of Requests for Proposal, negotiation, contract change control, performance monitoring, accepting deliverables, managing invoices and tracking drug supplies).

·      Collaborate with Clinical Development and Operations, Product Development, Regulatory Affairs, Quality Assurance, Logistics and Project Management to determine appropriate quantities, packaging configuration, labeling, and optimal shipping plans.

·      Conduct routine reviews and approvals of GMP documentation (manufacturing batch records, protocols, and investigations).

·      Participate in CDMO audits and site visits as required.

·      Contributes to organization processes across functions and interacts effectively with the other team members.

·      Take primary role in technical investigations and assessment of deviations particularly as related to data generation/gathering and analysis.

·      Writes internal procedures required to ensure GMP compliance

·      Supports and revises specifications and resolves technical issues with material suppliers.

·      Supports document preparation for Regulatory filings.

·      Participates in risk remediation/reduction and drive toward root cause and robust corrective action/preventative action to improve process reliability.

·      Oversee the technology transfer of drug product processes between production facilities.

·      Prepares written reports and oral presentations of project goals and progress to management.

Required Education & Qualifications

  • A university degree in organic/physical organic/analytical chemistry, pharmaceutics, pharmacy or pharmaceutical sciences. Graduate degree strongly preferred.
  • A minimum of 5 years’ experience in the pharmaceutical industry, directly related to oral formulation development and/or cGMP manufacturing of small molecule oral drug products.
  • Good knowledge of modern oral formulation technologies, including those for solubility enhancement, controlled release and reducing stability risks.
  • Good knowledge of project management methodologies and practices as pertinent to outsourced R&D and manufacturing (including management of risk, scope, budget and schedule).
  • Good knowledge and understanding of cGMP and of the US, Canadian and EU regulatory environments; previous experience with IND and CTA CMC submissions preferred.
  • Excellent written and oral communication skills, including the ability to communicate with scientific and non-scientific personnel.
  • Excellent attention to detail and commitment to providing accurate, high quality work.
  • Good organizational skills and the ability to manage multiple competing priorities.
  • Strong interpersonal and team skills to work both independently and collaboratively as part of a multidisciplinary team.

Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics. 

Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.

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