JOB TITLE: Subject Matter Expert, CMC Drug Substance Development
PYC Therapeutics is a drug-development company offering a new generation of RNA therapeutics to meet unmet need in disease.
We design and develop RNA targeted therapeutics which utilise a phosphorodiamidate morpholino oligomer [PMO] attached to our revolutionary delivery technology, the cell penetrating peptide [CPP].
The Director of Drug Substance Development will work with internal and external teams to meet Company timelines and objectives for advancing PYCs lead RNA therapeutics asset, along with all subsequent programs in targeting ophthalmology and other therapeutic areas. This key leader will be responsible for API development and lead the establishment of drug substance manufacturing process, related analytical methods, specifications and appropriate documentation. Along with the Drug Product SME, this leader will author and provide support for the CMC sections regulatory submissions as with all other related and necessary documentation.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Responsible for design and development of API processes and final form for pre-clinical and clinical development candidates
- Serve as interface between company and external collaborators, partners, vendors. Lead, provide technical guidance of, and manage route selection, process development, and characterization of final forms.
- Serve as drug substance SME for drug candidates from early development through registration.
- In addition to driving our lead clinical asset, collaboratively manage/provide technical guidance to CROs and CMOs in research and development of APIs, including R&D and manufacturing schedules with CMO partners
- Provide input on program development strategies, budgets, and timelines to ensure that both technical and business requirements are achieved
- Build and maintain strong working relationships with relevant internal Development and Discovery functions to effectively support on-going programs
- Prepare technical documents to support relevant, drug substance-related regulatory submissions and agency interactions
- Appropriate Degree in Chemistry, Pharmaceutics or related discipline.
- Minimum of 10 years’ experience in Drug Substance development in pharmaceutical or biotech industries, experience with peptide and oligonucleotide API development is a plus.
- Ability to individually plan experiments, write protocols and reports related to drug substance synthesis, characterization and manufacturing process development, validation and transfer.
- API Manufacturing experience in a cGMP environment.
- Expertise in the development of robust, fit-for-purpose analytical control strategies, analytical method development, validation and transfer, and analytical understanding for drug substance process development, scale up and technology transfer.
- Experience in identifying and managing CDMO, CRO, CMO; develop Request for Proposals, review proposals, negotiate and manage contracts.
- Write, review and edit key regulatory documents, technical reports, and analytical method packages to ensure high quality regulatory submissions.
- Proven experience with successful submission of Clinical Trial Applications (INDs) and Marketing Applications (NDAs) for NCEs.
Applications close 20 October 2021
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