Senior Manager, External Manufacturing
Company: Taysha Gene Therapies
Location: Dallas
Posted on: April 10, 2021
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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
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Keywords: Taysha Gene Therapies, Dallas , Senior Manager, External Manufacturing, Executive , Dallas, Texas
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