Process Chemistry Lead, Chemical Development
The Process Chemistry Lead will manage and coordinate the Process Chemistry activities for one or more pipeline programs (late clinical stage or life cycle) for the department. These internal and/or external activities include laboratory development, pilot-scale production, and technology transfer to / validation at production sites. The Process Chemistry Lead also represents the Chemical Process R&D department on CMC project teams and acts as Subject Matter Expert for relevant programs.
Leads and coordinates the Process Chemistry activities for one or more pipeline programs (late clinical stage or life cycle) for the department. These internal and/or external activities include laboratory development, pilot-scale production, and technology transfer to / validation at production sites.
Represents the Chemical Process R&D department on CMC project teams and acts as Subject Matter Expert for programs being managed.
- Actively represent Chemical Process R&D function on cross-functional CMC project teams, and coordinating with all other relevant functions.
- Conceive, plan, coordinate and manage route selection, process development and scale-up activities and personnel, both internally and at partners. Execute laboratory experimental work on own or other programs as needed.
- Provide timely and accurate estimate for resources and timelines necessary to execute process chemistry programs.
- Ensure successful and thorough development of safe, robust, environmentally friendly and cost effective processes for APIs, according to department workflow and fit-for-purpose expectations.
- Ensure successful and timely production of API clinical supplies (for trials or drug product development) as well as Technology Transfer of API processes to and Validation of API processes at manufacturing sites.
- Ensure detailed and comprehensive documentation of all relevant activities to comply with regulatory requirements, for intellectual property protection purposes, or to ensure complete capture of program and process knowledge.
- Actively contribute to the execution of Chem. Process R&D and Small Molecule CMC long term strategies.
- PhD in Chemistry with 5 years post graduate experience in small molecule process development in Pharmaceutical sector, or equivalent combination of education and relevant experience
- Strong knowledge of general synthetic organic chemistry, both theoretical and practical, with an understanding of innovator pharma development process.
- Prior experience with selection of chemical routes and development of safe, robust, cost effective chemical processes for small molecule APIs as well as scale-up in pilot or manufacturing facilities. Experience with technology transfer of processes to and validation processes at manufacturing sites would be advantageous.
- Experience in performing a wide range of laboratory activities as well as working with CDMOs and other partners for execution of activities.
- Knowledge of and prior experience with Quality by Design (QbD) principles and all components thereof.
- Understanding of current regulatory requirements and expectations applicable to pharma industry, and prior experience working in a cGMP environment.
- Proficiency in both English and French languages would be advantageous.
- Adept at using Microsoft Office and similar software tools.
- Ability to work within a cross-functional, matrix environment, as a leader and as a team player.
- Excellent communication and project management skills.
- Ability to deal with and manage change and uncertainty. Flexible and responsive.
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