Associate Director, Microbiology

3 days left

Taysha Gene Therapies
Durham County, North Carolina, US
Jun 04, 2021
Jun 17, 2021
Employment Type
Full time
Salary Type
Taysha 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 18 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: Associate Director, Microbiology

Reports to: Senior Director, Quality Control

Overview of Position

Taysha is currently seeking a seasoned pharmaceutical industry leader to join our team as Associate Director, Microbiology. This person will report to the Senior Director, Quality Control and will provide Microbiological oversight at Taysha's new AAV manufacturing facility located in Durham, NC. This role will provide strong leadership, strategic planning and technical expertise in support of the QC Microbiology team and sterility assurance oversight for Manufacturing Operations.

The Associate Director, Microbiology will provide strong leadership and guidance to the Microbiology laboratory operation and personnel, communicate clearly (in verbal and written form), and display exemplary organizational / leadership skills. In addition, the successful candidate will create an environment in which the team is highly motivated and engaged to work collaboratively within their team and cross functionally to deliver exceptional results and ensure long-term success.

As the Microbiological expert at the Durham facility, collaboration with Manufacturing Operations to provide technical oversight of sterility assurance for the manufacturing process is essential for success.

Essential Duties & Responsibilities
  • Provide management of the Microbiology team supporting stability, in-process and release testing, environmental monitoring, raw material testing and third-party microbiological testing oversight.
  • Microbiology expert for the Durham facility supporting manufacturing operations in all elements of sterility assurance.
  • Establish and sustain the Durham site environmental monitoring program.
  • Oversight and development of microbiology team budget including personnel, material and instrument requirements.
  • Accountable for microbiological method validation lifecycle management and lead regulatory agency communications relating to microbiology.
  • Support the authoring and approval of relevant regulatory submissions and annual product quality reviews.
  • Provide oversight of laboratory investigations to ensure root cause analysis and effectiveness checks are performed.
  • Adhere to lab performance key performance metrics.
  • Provide direction and oversight into the development and approval of QC SOPs, test methods, protocols and reports.
  • Assure the qualification, maintenance and calibration of microbiology laboratory instrumentation.
  • Responsible for establishment of the microbiology laboratory facility and the associated hiring plan.

Minimum Qualifications (Education & Experience)
  • Min 7+ years of relevant industry experience and a degree in pertinent life sciences.
  • 3+ years of management experience including hiring, mentoring and leading teams.
  • Expertise in microbial QC testing.
  • Experience with microbiological test methods optimization, validation, and transfers.
  • Strong knowledge of cGMP/ICH/ FDA/EU requirements
  • Proficient in streamlining the generation, review, and approval of test methods, development reports, qualification reports, stability protocols, and product characterization studies in support of technology transfers and IND/IMPD/BLA/MAA filings.
  • Proven leadership experience and people management skills.
  • Strong collaboration and team-building, communication, and organizational skills required.

Preferred Qualifications (Additional Requirements)
  • Strong technical knowledge and skill base in microbiological science.
  • Excellent organizational skills, with an ability to embrace change and multi-task in an extremely fast-paced environment.
  • Method validation and equipment qualification.
  • Continuous improvement methodologies.
  • Statistical analysis of data.
  • Demonstrated ability to influence at all organizational levels through clear, concise and impactful verbal and written communication skills.
  • Effective presentation and meeting skills within all levels of the organization and with external colleagues and collaborators.
  • Ability to influence and motivate others while maintaining a cohesive team environment.
  • Budgeting processes/business acumen.

The level of this position will be based on the final candidate's qualifications.

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.

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