Sr. Scientist/Principal Scientist, Chemical Process R&D
The Sr. Scientist/Principal Scientist of Chemical Development will report to the head of Chemical Process R&D and be responsible for the development and implementation of practical/robust synthetic processes and controls to support small molecule programs with the goal of delivering preclinical and clinical drug substances meeting program needs. Individual will be responsible accountable for defining and developing synthetic processes that comply with regulatory requirements and manufacture API to support clinical trials, registrational and commercial batches.
- Work with multi-functional project teams to define API requirement and supply strategy
- Work closely with cross functional teams to ensure seamless transitions between drug substance and drug product programs and suppliers
- Build appropriate risk management strategies for chemical development and manufacturing
- Responsible for phase appropriate synthesis route design, practical implementation of synthesis processes and controls for regulatory starting materials, intermediates and drug substances for research and development programs
- Conduct API synthetic route design, scouting and process development and manufacturing, tech-transfer and manufacturing at CROs or CMOs.
- Critical review of proposals from CROs or CMOs; perform appropriate due diligence as needed to ensure CROs and CMOs can support the requirements of individual chemical development programs effectively
- Directly lead and manage CMO activities, provide technical supervision and guidance. Provide manufacturing oversight for the production of drug substance.
- Resolve technical issues or deviations in coordination with internal and external quality control, quality assurance, and regulatory groups
- Facilitate and enable quick problem solving
- Implementation of risk-based approach to development, QbD and DoE principles at appropriate development stages
- Lead fate and tolerance studies, genotoxic impurity evaluation and establish the framework of for the control strategy of the drug substance from early development with a long-term vision of the commercial process
- Lead/Support technical transfer, qualification and validation of starting material, intermediate or API processes as needed
- Support PAR studies and pre-validation and validation activities for drug substance
- Write, review and approve study protocols. Approve manufacturing batch records, compose developmental and campaign reports and maintain relevant CMC files, reports and data packages.
- Provide scientific update to cross-functional teams
- Draft and review regulatory sections in support of CMC submissions.
- Maintain up-to-date scientific knowledge through regular literature review and participation in conferences. Leverage external data and publications and relevant industry benchmarking information to drive experimental design, data analysis and functional/cross-functional strategy development
- Participate in an interactive, highly collaborative, team-oriented culture, interfacing primarily with the discovery functions and the CMC team
- Doctoral (Ph.D.) degree (or M.S. with equivalent experience) in Chemistry, Chemical Engineering or related discipline with a minimum of 5 years of relevant industrial experience.
- Hands-on experience in non-GMP, GMP API process development, scale up and manufacturing
- Demonstrated knowledge of drug development, CMO management, manufacturing, supply chain management and regulatory CMC.
- Working knowledge of current Good Manufacturing Practices (cGMP).
- Proven ability to develop and implement strategic plans.
- Demonstrated competencies in a core CMC discipline such as drug substance process development and manufacturing.
- Proven problem-solving skills are a must.
- Must possess the ability to effectively manage multiple projects to achieve established deadlines.
- Ability to adapt rapidly and change focus based on real time results and findings.
- Outstanding written and verbal communication skills.
- Ability to travel up to 30% domestically and internationally