Associate Director, Viral Vector Technology Development

Job Description Summary: Job Description:As part of our continued growth and expansion, the newly created Associate Director, Viral Vector Technology Development (VVTD) - Gene Therapy leads, and actively contributes to, the exploration and development of innovative technologies for gene therapy viral vector production. This includes, but may not be limited to, molecular biology, cell and virus culture, as well as small-scale bioreactor process design and execution applying Design of Experiments (DOE) approach when appropriate.This individual is expected to lead the evaluation and development of new technologies that enhance the production of Adeno-Associated Virus (AAV) vector beyond current industry-observed levels. She/he leads the design and execution of proof-of-concept studies and tech transfer to process development for further evaluation and scaleup/manufacturability assessment. She/he provides Subject Matter Expertise (SME) for internally executed processes, as well as external, Contract Development Manufacturing Organizations (CDMOs)-executed processes, to ensure their proper execution. She/he interacts extensively with Plasmid Development, Upstream and Downstream Process Development and Analytical Development personnel to deliver high-quality and robust processes in a regulated environment. S/he manages direct reports.The incumbent works cross-functionally with internal departments and external resources as appropriate on AAV CMC development-related issues.The Associate Director, Viral Vector Technology Development - Gene Therapy supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.Primary duties/responsibilities:Generates technology development plans with of the goal of establishing highly productive upstream processes and obtaining buy-in from peers and leadership.Provides leadership and actively contributes to upstream viral vector process development activities for both internal and external projects.Leads, designs, and executes small-scale well plate, T-flask, shake flask, 2-D multilayer flask, and stirred tank bioreactor studies to support the development of cell, virus, and plasmid DNA-based gene therapy upstream manufacturing processes.Applies experience with transfection- and infection-based viral vector gene therapy process development and assists his/her direct reports (as appropriate) to develop/further develop their experience in these skills.Work closely with Research, Discovery, and Plasmid team to advance scientific understanding for GT products. Collaborates with Analytical Development to build scientific knowledge, capabilities, and strategies in gene therapy product characterization that enable fast to clinic/fast to market product development and commercialization.Leads and assures the effective execution of science-driven, phase appropriate, and risk-based process development strategies to support development projects from candidate nomination to clinical development and commercial manufacture.Leads, and actively contributes to writing and/or performing the QC review of relevant sections of global regulatory filings. These include, but may not be limited to, INDs, BLAs and ex-US filingsManages, mentors, coaches and cross-trains junior scientists to build a highly functional team focused on developing next-generation vector manufacturing technologies. This includes providing scientific and technical support to troubleshoot and solve scientific challenges.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, Biochemical Engineering, Biochemistry or other relevant discipline and a minimum of 7 years of progressively responsible experience in biologics and/or gene therapy process development roles OR a Master''s degree in these same disciplines and a minimum of 10 years of relevant experience OR a Bachelor''s degree in these same disciplines and a minimum of 11 years of relevant experience.* Special knowledge or skills needed and/or licenses or certificates required.Expert level knowledge of mammalian cell culture, plasmid cloning, stable cell line generation, virology, and upstream processes is required.Demonstrated experience designing and executing experiments evaluating new technologies including but not limited to: new bioprocessing equipment, novel transfection or electroporation technologies, cell cloning, cell intensification and perfusion process development, and media development.Ability to identify higher-risk opportunities, establish proof-of-concept data, and present cost/benefit analyses to management/leadership.Demonstrated, hands-on experience overseeing and conducting technology transfer-in and transfer-out of upstream biologics, vaccine, or gene therapy manufacturing processes in early phases of development.Significant experience in laboratory operations, including budgeting, capex procurement, safety, and status reporting to Senior Management is preferred.Demonstrated understanding of, and applied experience with, cell-based assays, qPCR, HPLC, ELISA, SDS-PAGE, mass spectrometry, nucleic acid and protein sequencing.Ability to influence without direct authority.Demonstrated leadership ability and experience managing, coaching and mentoring direct reports.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.Experience with relevant molecular biology techniques preferred, such as DNA plasmid cloning, transformation, microbial cultures, and plasmid purification.Experience with HEK293, BHK, Hela, and/or Sf9 culture preferred. Experience with herpesvirus- or adenovirus-based AAV production methods preferred.Experience in GMP upstream, downstream clinical manufacturing and small-scale product filling is preferred.Demonstrated ability to lead upstream process development activities conducted by Contract Research Organizations (CROs)/Contract Development and Manufacturing Organizations (CDMOs).Knowledge of GLP and GMP requirements as they pertain to upstream process development and clinical manufacturing for gene therapy productsDemonstrated, applied knowledge of CMC and regulatory requirements, including the development of process and product specifications and writing and reviewing development reports.Small company and/or start-up experience.Experience in high-level interactions with domestic and international Regulatory agenciesAbility to make and defend high-level decisions as they relate to upstream process development**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.Click here to return to the careers page

Created: 2025-10-04