Senior Manager, External Manufacturing

Company: Taysha Gene Therapies
Location: Dallas
Posted on: April 10, 2021

Job Description:

Company OverviewTaysha Gene Therapies is a patient-centric gene therapy company focused on developing and commercializing AAV-based gene therapies for the treatment of monogenic diseases of the central nervous system in both rare and large patient populations. The company was founded in partnership with The University of Texas Southwestern Medical Center, or UT Southwestern, to develop and commercialize transformative gene therapy treatments. Together with UT Southwestern, we are advancing a deep and sustainable product portfolio of 17 gene therapy product candidates, with exclusive options to acquire four additional development programs at no cost. By combining our management team's proven experience in gene therapy drug development and commercialization with UT Southwestern's world-class gene therapy research capabilities, we believe we have created a powerful engine to develop transformative therapies to dramatically improve patients' lives. In addition to our product pipeline candidates, we are building a platform of next-generation technologies to optimize key components of our AAV-based gene therapies, including redosing, transgene regulation and capsid development.Position: Senior Manager, External ManufacturingReports to: Executive Director, External ManufacturingOverview Of PositionThe Senior Manager, External Manufacturing is responsible for external process development and manufacturing to support Taysha's gene therapy portfolio including partner technical assessment and selection, tech transfer and process establishment, process oversight as person-in-plant, and performance management. The incumbent in the role will work closely with other leaders in the TechOps, Quality and Regulatory organizations to ensure harmonized strategies are executed to deliver clinical and commercial supply and ensure on-time delivery of gene therapy products and critical intermediates.Key ResponsibilitiesEssential Duties & Responsibilities* Leads external manufacturing deliverables that aligns with corporate objectives. * Responsible for technical assessment of potential manufacturing partners and provides input into partner selection.* Oversight of external process development and manufacturing for Taysha's outsourced product portfolio.* Ensures appropriate person-in-plant oversight for critical operations. * Leads data reviews, of external development and manufacturing activities* Ensures timely routing and review of all master batch records and deviation reports. * Develops scopes of work and contributes to contracts and program budgets for external programs. * Oversees cGMP operations in compliance with cGMPs and Taysha's internal SOP's and other procedures.* Communicates progress versus plan and escalates issues as needed to the Executive Director, External Manufacturing. * Drafts and delivers Regulatory source documents in support of INDs, CTAs, BLAs and other agency correspondence. Basic Requirements* Bachelor's degree in a scientific discipline with minimum of 8+ years of experience in the pharmaceutical industry and 4+ years of management experience. Masters or Ph.D. is preferred.* Expertise in biopharmaceutical process development, GMP manufacturing and experience with external partnership management.* Excellent written and verbal communications and teamwork skills.* Must be goal oriented, quality conscientious, and customer focused.In-depth knowledge of regulatory requirements from FDA and other global health authoritiesPreferred Qualifications* The ideal candidate will have relevant knowledge and industrial experience in the field of bioprocess development for manufacture of AAV gene therapy vectors or other relevant complex biologics (e.g. viral vectors, plasmid DNA) and will have experience in transferring processes to external cGMP facilities for clinical or commercial manufacture. * The incumbent is expected to possess a high level of skill and experience with key bioprocess techniques including; cell culture, cell line development, bioreactor operation and scale-up, column chromatography (size-exclusion, affinity, ion-exchange), tangential flow and normal flow filtration. * Project management experience is a plus.The level of this position will be based on the final candidate's qualifications and experience.Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.Taysha is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at Taysha are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, national, social or ethnic origin, sex (including pregnancy), age, physical, mental or sensory disability, HIV Status, sexual orientation, gender identity and/or expression, marital, civil union or domestic partnership status, past or present military service, family medical history or genetic information, family or parental status, or any other status protected by the laws or regulations in the locations where we operate.Powered by JazzHRLhL4x3LDPh

Keywords: Taysha Gene Therapies, Dallas , Senior Manager, External Manufacturing, Executive , Dallas, Texas