NeoTX is a private biopharmaceutical company developing pharmaceuticals that enhance the ability of the immune system to recognize and eliminate cancer
Location:
Rehovot, Israel
Job Description:
The CMC leader will be responsible for CMC-related activities across the portfolio including drug substance and drug product, process development, pre-formulation, formulation, pilot/feasibility manufacturing, and manufacture, including analytics. Responsible for assuring coordination of sourcing, assembly, supply and distribution of all clinical trial materials. The ideal candidate will be a highly motivated individual with experience and interest in working in a small, entrepreneurial environment with broad responsibilities and opportunities.
Duties and Responsibilities
- Overall responsibility for all drug substance and drug product activities from preclinical development through clinical supplies for multi-national studies
- Identification, selection, contracting and management of Contract Manufacturing Organizations (CMOs) for process optimization, cGMP manufacture and supply of Drug Substance (DS) and Drug Product (DP) and all clinical supply materials in support of clinical programs
- Projection of DS, DP and other clinical supply needs for preclinical and clinical programs (with clinical team), and associated budgets (with finance)
- Management of supply chain, timelines and logistics (including import/export of DS, DP and clinical trial supplies) in support of clinical studies
- In coordination with Quality Assurance, implement stage appropriate analytical methods, protocols and validation, and ensure that all CROs and CMOs are using systems and processes in compliance with all relevant regulatory standards
- Management of stability program and logistics, including coordination of analyses for DS and DP
- Writing and reviewing documents for clinical trial applications (IMPD, INDs / regulatory section submissions); represent the company as the CMC expert before Israeli, U.S. and European regulatory authorities
- Prepare, review or edit cGMP batch records, CMC regulatory and Quality documents
- Evaluate and oversee implementation of strategy and DOE (design of experimentation) for optimizing and controlling quality of bulk API and DP using CROs and CMOs
- Delivery of robust, scalable and cost-effective manufacturing routes and drug product formulations that meet or exceed the target clinical profile
- Formulation design/development for clinical programs
- Prepare technical reports, publications and presentations
Required Education, Experience and Qualification:
Profile requirements
Skills and Background
- Substantial experience in managing US and International CRO/CMOs for cGMP manufacture of proteins, DS and DP.
- Substantial experience with projects in clinical development e.g. Phase 1 through Phase 3 including biologics and preferably also small molecules.
- Experienced with cGMP manufacturing and IND, CTA and NDA filings; thorough knowledge of relevant MOH, FDA and EMEA regulations
- At least 5 years relevant experience in a pharmaceutical or biotechnology CMC/cGMP
- environment
- Experience in supply chain management
- PhD or MS with 5+ years of experience preferred; Advanced degree in Pharmaceutical Chemistry, Organic Chemistry, Pharmaceutics, Pharmaceutical Science, or related scientific discipline
- Able to identify and resolve critical issues in biologics manufacturing in particular
- Experience implementing technical, strategic and operational plans
- Excellent written and verbal communication skills, exceptional interpersonal and management skills to collaborate with and direct the work of others on assigned projects (including both internal teams and external collaborators)
Please send CV with contact information to: careers@neotx.com
