Roles and Responsibilities:
Responsible for drug substance process development and technical transfer including stability programs, working in collaboration with other teams (Research, analytical and QA)
Responsible for the management of CMC CMOs and activities related to Regulatory Starting Materials, and Drug Substance programs working in collaboration with analytical and QA department and including management of Impurities and Reference Standards.
Plan and carry out Tech-Transfer to CMOs (in collaboration with analytical and QA department) including protocol, design, monitoring, science, data management, statistics and reporting
Plan and manage as per Ayala’s work plan, the manufacture of DS batches for Phase I, II & III under appropriate cGMP requirements according to the relevant product life cycle.
Manage drug substance programs to support clinical studies working in collaboration with Ayala CMC Pharma Manager and with CMC Analytical Manager.
Prepare and support IP applications
Prepare Pharmaceutical Development Report
Draft and review regulatory documents/responses related to RSM and DS CMC in collaboration with Analytical, Regulatory affairs and QA.
Professional:
Substantial experience in managing CMOs for the manufacture of cGMP DS.
Substantial experience with project management of Phase 1 through Phase 3 programs
Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations.
At least 5 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP environment.
Managerial:
Lead all Chemistry CMC related activities
Prepare Chemistry CMC budget and manage timelines
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Interfaces:
Support CMC Pharma Programs
Research and nonclinical development to provide all test articles (Labelled materials, toxicological DS)
Regulatory affairs for all submissions and responses
Support due diligence(s)
Prepare and participate in preapproval inspections
Professional experience:
Experience in managing CMOs for the manufacture of cGMP DS.
Experience with Phase 1 through Phase 3
Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant FDA and EMEA regulations.
At least 5 years relevant experience in large pharmaceutical and biotechnology cGMP environment.
Highly motivated to learn and work in a dynamic and time-demanding environment.
Education:
MSc with 5+ years of relevant experience
Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, Chemical Engineering or related scientific discipline.
