As part of our plan for growth, in July of 2019, PTC is expanding and opening operations at the New Jersey Center of Excellence in Bridgewater NJ.
The Scientist I, Analytical Development - Gene Therapy actively contributes to, and provides scientific Subject Matter Expertise (SME) for, assays (qPCR, cell-based, immunoassay) in support of the gene therapy analytical development group. This involves collaborating with scientific leadership within the analytical development organization to help establish, and routinely run, the characterization assays necessary to support the discovery, formulation development, process development and manufacturing of gene therapy products.
The incumbent works cross-functionally with internal departments and external resources as appropriate on analytical development-related issues.
The Scientist I, Analytical Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Actively contributes to the development and execution of the product characterization analyses (qPCR, cell-based assay, immunoassay) required to support method development/optimization, method transfer and analytical development activities associated with the process development and manufacturing of gene therapy products.
Contributes to the scientific advancement of activities conducted in-house or by Contract Research Organizations (CROs)/Contract Manufacturing Organizations (CMOs).
Provides technical expertise within the analytical development team to review analytical data and contribute to method development and product characterization.
May contribute to authoring and/or reviewing 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 by maintaining and actively advancing his/her knowledge regarding relevant topics. S/he may also participate in industry trade groups and conferences.
May oversee or mentor 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 OR a Master’s degree in these same disciplines 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.
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 are preferred - including the determination of product specifications and extended analytical characterization.
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.
Experience in interacting with CROs/CMOs.
Small company and/or start-up experience.
* 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.