PTC Therapeutics, Inc.
Associate Dir, Upstream Process Development – Gene Therapy (Biotech)
The Associate Director, Upstream Process Development (PD) – Gene Therapy leads, and may actively contribute to, the engineering of upstream process development activities for gene therapy vector production. This includes, but may not be limited to, cell and virus culture as well as small-scale bioreactor process DOE design and execution.
This individual leads the design and execution of scale-up studies from pilot through full clinical and commercial scale. S/he also functions as PTC's Person in the Plant (PIP). In this capacity, s/he provides Subject Matter Expertise (SME) for internally executed processes, as well as external, Contract Development Manufacturing Organizations (CDMOs)-executed processes, to ensure their proper execution. S/he interacts extensively with downstream Process Development, Analytical Development and Manufacturing personnel to deliver high-quality and robust upstream processes in a regulated environment.
S/he manages direct reports.
The incumbent works cross-functionally with internal departments and external resources as appropriate on upstream process development-related issues.
The Associate Director, Upstream Process Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
* 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.
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.