PTC Therapeutics, Inc.
Associate Director, CMC Development - Gene Therapy (MA, NJ, or Northeast US/Mid-Atlantic Region remote based) (Biotech)
The Associate Director, CMC Development - Gene Therapy is responsible for all aspects of CMC development, from nomination to commercialization, for one or more products in PTC's gene therapy portfolio. This includes, but may not be limited to, providing strategic and technical leadership for the function and the teams responsible and accountable for phase-appropriate CMC development and execution of manufacturing batches to ensure the supply of pre-clinical, clinical, and commercial material. This role also oversees the strategy and generation of phase appropriate documentation to support regulatory submissions and interactions.
This position works cross-functionally with internal departments and external resources (process and analytical development, manufacturing, project management, quality, and regulatory) on CMC development-related issues to ensure the desired target product profile is achieved.
S/He may manage direct reports.
The Associate Director, CMC Development - Gene Therapy support adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Note: This position can be based out of our Lynnfield, MA, Hopewell, NJ facilities or be remote (home based) within the Northeast/Mid Atlantic US region
* Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
* Travel requirements
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.