Scientist , Analytical Development (Bioassay Development) - Gene Therapy at PTC Therapeutics, Inc. in Pennington, New Jersey

Job Description:

Job Description Summary:

Job Description:

The Scientist, Analytical Development - Gene Therapy actively contributes to, and provides scientific Subject Matter Expertise (SME) for, assays (PCR based, cell-based, immunoassay, bioinformatics, transcriptome/proteomic) 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, Analytical Development – Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.

Primary duties/responsibilities:

• Actively contributes to the development and execution of the product characterization analyses (PCR- based, cell-based, immunoassay, bioinformatics, transcriptome/proteomic) required to support method development/optimization, method transfer and analytical development activities associated with the process development and manufacturing of gene therapy products.

• Actively learns new technology and applies appropriate methods for gene therapy product characterization

• 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 and a minimum of 2 years of relevant experience in vaccine/cancer research/new drug development OR a Master’s degree in these same disciplines and a minimum of 5 years of relevant experience.

* Special knowledge or skills needed and/or licenses or certificates required.

• Hands-on/applied experience with the development of potency assays for gene therapy products, biomarker identification, or serology assay (i.e. neutralization).

• 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.

• Demonstrated ability to take the initiative to move projects forward.

• Experience mentoring junior scientists to help them drive projects to completion.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in interacting with CROs/CMOs.

• Small company and/or start-up experience.

• Experience in CMC analytical and regulatory requirements including the determination of product specifications and extended analytical characterization.

**At PTC Therapeutics we are seeking candidates in the United States who are fully vaccinated against COVID-19 or who will be fully vaccinated by the time they begin the position.

EEO Statement:

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.

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