Director, Analytical Development - Gene Therapy (Molecular Biology Based Assays)

Job Description Summary:Job Description:The Director, Analytical Development (Molecular Biology) - Gene Therapy leads all molecular biology-based assay related activities required to support the development, qualification, validation, and transfer of all required assays. She/He 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 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 direct reports.The Director, Analytical Development (Molecular Biology) - Gene Therapy ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate. Primary duties/responsibilities:

• 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.

• Leads, and actively contributes to, 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.

• Manages and mentors scientists of varying levels to build a highly functional Analytical Development (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.

• Manages, coaches and mentors direct reports.

• 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 or related discipline and a minimum of 8 years of progressively responsible experience in biologics and/or gene therapy analytical development roles in a pharmaceutical, biotechnology or related environment.

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

• Demonstrated experience providing strategic leadership for the development and implementation of the molecular biology assays required to support the AD activities associated with gene therapy or biologic products.

• Demonstrated expertise and applied experience with the analytical methods used for gene therapy for in-process testing, release testing, and characterization.

• 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 molecular biology-based assay methodologies (includes, but may not be limited to, QPCR/ddPCR-based assays for quantitation/detection of product, residuals and potential contaminants for process monitoring and release and Stability, DNA sequencing and other molecular assays) and working knowledge of immunoassays, cell-based and analytical chemistry assays.

• Demonstrated experience leading/managing 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.

**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.