As part of plan for growth, in July of 2019, PTC is expanding and opening operations at the New Jersey Center of Excellence in Bridgewater NJ.
The Senior Scientist, Analytical Development - Gene Therapy leads, actively contributes to, and provides Subject Matter Expertise (SME) for, the potency area (qPCR, cell-based assay, ELISA) of the gene therapy analytical development group. This involves establishing, and routinely running, the potency assays necessary to support the characterization, formulation development, process development and manufacturing of gene therapy products.
S/he manages direct reports.
The incumbent works cross-functionally with internal departments and external resources as appropriate on potency and analytical development-related issues.
The Senior Scientist, Analytical Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Provides leadership for, and actively contributes to, the development and execution of the potency-related analyses (qPCR, cell-based assay, ELISA) required to support the characterization, method development/optimization, method transfer and analytical development activities associated with the process development and manufacturing of gene therapy products.
Provides oversight for potency-related activities conducted in-house or by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
Provides potency-related technical expertise in cross-functional team(s) to review analytical data and provide guidance on method development and product characterization.
Authors and/or reviews method development reports, SOPs, validation protocols/reports, comparability protocols and reports, justification of specifications, and other relevant sections of regulatory filings. These include, but may not be limited to, INDs, IMPDs and BLAs.
Assists in advancing PTC’s scientific and regulatory capabilities via active participation and leadership across industry trade groups and conferences.
Supervises and mentors junior scientists. This includes providing scientific and technical support to help troubleshoot and solve scientific challenges.
Builds the scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.
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.
Performs other tasks and assignments as needed and specified by management.
* Minimum level of education and years of relevant work experience.
PhD in molecular biology, virology, biochemistry or related field and a minimum of 5 years of relevant and progressively responsible experience in biologics and/or gene therapy analytical roles.
* Special knowledge or skills needed and/or licenses or certificates required.
Demonstrated expertise, and hands-on/applied experience with, the development of potency assays for virus products.
Demonstrated understanding of other analytical methods used for gene therapy characterization.
Experience in CMC analytical and regulatory requirements, including the development of product specifications and extended analytical characterization.
Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.
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 at various stages of development.
*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.