As part of our plan of continued growth, in July of 2019, PTC is expanding and opening operations at the New Jersey Center of Excellence in Bridgewater NJ.
The Director, Process Development (PD)- Gene Therapy leads all activities required to develop, scale-up, validate and transfer gene therapy product manufacturing processes. This involves the successful delivery of scale-up studies from pilot through full clinical and commercial scale.
S/he will manage all subject matter experts (SMEs) for both internal and external (CDMO) projects in all areas of process development in the gene therapy space.
S/he works cross-functionally in a matrix management environment that includes Analytical Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory, Supply Chain and Discovery Research.
S/he will manage the assets and personnel in the PD department to achieve milestones within budget. S/he manages direct reports.
The Director, Process Development – Gene Therapy ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Provides leadership for the activities associated with the development of processes relevant to viral vector/gene therapy products including all aspects of upstream and downstream process development in a regulated environment.
Assures the effective transfer of processes to Clinical Manufacturing in a phase-appropriate fashion, to support pre-clinical, clinical and commercial activities.
Designs and executes process validation studies to support BLA and international regulatory requirements.
Drives the development of upstream and downstream platform processes for each cell and viral vector type used for manufacturing.
Actively contributes to, and assures, the development of, and effective execution of, science-driven, phase appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
Drives process development to support timely IND, BLA and all relevant ex-US regulatory filings.
Supervises, mentors and cross-trains scientists of varying levels to build a highly functional PD team that is cross-trained in at least two PD areas.
Collaborates with Analytical Development to build the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
A PhD in Chemical Engineering, Biochemical Engineering, Biochemistry or other relevant discipline and a minimum of 8 years of progressively responsible experience in biologics and/or gene therapy process development roles OR a Master’s degree in these same disciplines and a minimum of 10 years of relevant experience OR a Bachelor’s degree in these same disciplines and a minimum of 15 years of relevant experience.
* Special knowledge or skills needed and/or licenses or certificates required.
Expert level knowledge of GLP and GMP requirements as they pertain to gene therapy process development and Quality Control (QC) testing.
Expert level knowledge of CMC and regulatory requirements, including the development of process and product specifications and writing and reviewing development reports.
Demonstrated and significant applied experience with technology transfer-in and transfer-out of gene therapy manufacturing process at all levels of development.
Significant experience in laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management.
Demonstrated and significant experience with single-use bioprocessing equipment and its application to gene therapy process development and GMP manufacturing.
Expert level knowledge of mammalian and insect cell culture and associated downstream processes.
Demonstrated understanding of, and applied experience with, cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry and nucleic acid and protein sequencing.
Demonstrated ability to lead upstream and downstream process development activities conducted by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
Proficiency with Microsoft Office.
Excellent verbal and written communication skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.
*Special knowledge or skills and/or licenses or certificates preferred.
Small company and/or start-up experience.
Direct experience in high-level interactions with domestic and international Regulatory agencies.
Ability to make and defend high-level decisions as they relate to process development.
Ability to present to, and interact with, Senior Leadership.
Demonstrated experience in GMP upstream, downstream manufacturing and small-scale product filling is 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.