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, Analytical Development (AD) - Gene Therapy leads all activities required to support the development, qualification, validation and transfer of all required assays. She/She is also responsible for the review and approval of related reports and serves as the Subject Matter Expert (SME) for both internal and external assay development/analytical development projects for gene therapy products.
S/he works cross-functionally will be highly interactive and function at a high level in a matrix management environment that includes Process Development, Clinical and Commercial Manufacturing, Quality Assurance, Quality Control, Regulatory Affairs, Supply Chain, and Discovery Research.
S/he manages the assets of the Gene Therapy Analytical Development organization and manages direct reports.
The Director, Analytical 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 assays relevant to viral vector/gene therapy products. This includes, but may not be limited to, the development of in-process testing, in-process control, characterization and method development/optimization.
Assures the effective transfer of all methods to Quality Control in a phase-appropriate fashion, to support pre-clinical, clinical and commercial activities.
Actively contributes to, and assures, the development of science-driven, phase appropriate, and risk-based analytical development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.
Drives assay development to support timely IND, BLA and all relevant ex-US regulatory filings.
Supervises and mentors scientists of varying levels to build a highly functional AD team that is cross-trained in at least two AD assay areas.
Builds 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 molecular biology, virology, biochemistry, or related discipline and a minimum of 8 years of progressively responsible experience in biologics and/or gene therapy analytical development roles.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated expertise and applied experience with the analytical methods used for gene therapy for in-process testing, release testing and characterization. This experience will include applied experience with potency assays.
Expert level knowledge of CMC analytical and regulatory requirements, including the development of product specifications and extended analytical characterization.
Significant experience in laboratory operations, including budgeting, capital expense procurement and IQ/OQ, safety, and status reporting to Senior Management.
Expert level knowledge of GLP and GMP requirements as they pertain to analytical development and Quality Control (QC) testing.
Expert level laboratory skills for analysis of pharmaceuticals and/or biopharmaceuticals.
Functional knowledge of mammalian and insect cell culture.
Demonstrated expertise and applied experience with cell-based assays, molecular biology-based assays (e.g., qPCR, sequencing), ImmunoAssays (ELISA, Western Blots) and advanced understanding of analytical chemistry methodologies (HPLC, mass spectrometry).
Demonstrate ability to lead/manage analytical 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 analytical development.
Ability to present to, and interact with, Senior Leadership.
* 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.