POSITION OBJECTIVE: Our Project Manager, Small Molecule Drug Product Manufacturing is responsible for managing key activities across Chemistry, Manufacturing and Controls (CMC) disciplines. Primary focus is management of oral drug product manufacture for clinical supplies. Works with internal project teams from early to late stage drug product development and external partners including CMOs and CROs.
Essential Job Functions/Responsibilities
- Manage manufacturing activities of oral solid/liquid dosage forms at external Contract Manufacturing Organizations (CMOs).
- Manage development of manufacturing processes improvements related to optimization, validation, characterization and scaling batch sizes to match stage of clinical development.
- Review/approve master batch records and protocols for drug product manufacturing runs, analytical release testing, stability studies and investigations as required.
- Ensure that all drug product manufacturing work at the CMO is executed in accordance with documented work orders and cGMP requirements.
- Oversee the technology transfer of drug product processes between production facilities.
- Proactively identify, communicate, and resolve risks of current manufacturing processes and supporting supply chain.
- Provide project specific support to resolve issues, as required.
- 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.
- Provide supply forecasts and requirements to the CMC team to ensure appropriate delivery schedules of drug product for clinical use.
- Perform contract related activities with CMO’s.
- Support Regulatory CMC team through various types of regulatory filings and annual updates.
Required Education & Qualifications
- BS in Chemistry, Chemical Engineering or Pharmaceutical Sciences or related field required. Graduate degrees a plus, but not required.
- 2+ years of experience in Pharmaceutical Project management. Experienced in leading or working in a cross-functional team-oriented environment in the bio or pharmaceutical industry.
- Knowledge in pharmaceutical product and analytical development, process validation and experience with CMC documentation for manufacturing and testing is necessary.
- Working knowledge of CMC-related Regulatory guidance.
- Knowledge of GMP, GLP, GCP and GDP compliance requirements.
- Understanding of oral drug formulation, process development and scale-up; packaging, technology transfers.
- Experience with fluid bed and spray drying processes a plus.
- Project Management experience managing CMC development programs.
- Excellent communications skills in a cross-functional environment.
- Proficiency in analysis of scientific data and results with ability to review scientific documents including reports, publications, and regulatory submissions.
- Work comfortably within a fast-paced and dynamic work environment and able to embrace change.
- Excellent writing skills; detail oriented for careful document review, accurate data transcription and QC against source material.
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.