Manager, AAV Process Development

at  Precision Biosciences

SUMMARY

The Manager, AAV Process Development will lead a team of experienced AAV Process Development engineers progressing pre-IND and clinical-stage AAV gene editing programs toward commercialization. Under this person’s leadership, the AAV Process Development team will continue refining and advancing a best-in-class AAV drug substance and drug product manufacturing platform for PBGENE drug candidates. The ideal candidate for this position is an experienced Scientist/Engineer with a strong background in viral vector biology and manufacturing, and prior people management experience. The candidate should be proficient in upstream and downstream process development, process scale-up, and tech transfer to GMP manufacturing. This person will be a hands-on manager, participating in lab activities and batch execution while handling day-to-day leadership responsibilities for a team of Research Associates and Engineers. This leader will collaborate across functional areas, working closely with MS&T, Analytical Development, Quality Assurance, and Research leads to ensure project advancement, rapid and best-in-class execution, and clear communication of challenges and opportunities.
Essential Duties and Responsibilities

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position. This list contains the major duties and requirements of the job and is not all-inclusive. Incumbent(s) may be expected to perform role-related duties other than those contained in this document.

• Manage a team of process engineers developing best-in-class AAV manufacturing processes
• Develop and clearly communicate team goals, aligned with CMC and corporate objectives
• Manage and mentor team members; provide feedback and coaching for individual development
• Manage the daily operation of the team, including delegation of tasks
• Provide hands-on technical oversight of development activities
• Design and execute AAV process optimization and characterization studies, providing expertise and presenting results in cross-functional interactions
• Contribute to the definition of critical quality attributes and manufacturing control strategies
• Apply Quality by Design principles to build process and product understanding
• Work closely with MS&T to:
• Support technology transfer activities to external CDMO partners
• Provide technical expertise and assist in the review of Batch Records, SOPs, Change Controls, manufacturing campaign summary reports and process validation strategy documents
• Lead technical troubleshooting, and support manufacturing investigations, root cause analyses, CAPAs, impact and risk assessments and change controls
• Work with Analytical Development to develop fit-for-purpose assays and analytical tools to improve process and product understanding
• Develop and diligently manage annual capital and operating budgets
• Lead the planning and production effort for IND-enabling batches at the 50L and 200L scale
• Contribute to the writing and review of US and ex-US regulatory filings and updates
• Ensure development activities are properly documented to enable seamless use as supporting documentation for filings
• Develop and provide technical reports supporting process changes and improvements as well as process characterization/pre-validation
• Remain current with regulatory and scientific advances relevant to the manufacture and process validation of gene therapies

QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required to perform this job successfully.

Required:

• BS in Chemical Engineering, Biochemistry, Bioengineering, or similar discipline with a minimum of 8+ years of industrial bioprocess development experience, or equivalent combination of education & experience
• Proven hands-on lab experience developing scalable viral vector manufacturing processes
• Excellent interpersonal, verbal and written communication skills
• Ability to think critically, and demonstrated troubleshooting and problem-solving skills
• Prior experience managing people
• Strong organizational skills and the ability to manage many projects simultaneously
• Proficiency with Microsoft Office software suite, and DOE/statistical software such as JMP or Minitab

Preferred:

• MS or PhD in Chemical Engineering, Biochemistry, Bioengineering, or similar discipline
• Strong familiarity with AAV biology and manufacturing strategies
• Proven ability to collaborate effectively across functions and levels, especially with colleagues in MS&T, Analytical Development, and Research functions
• Experience writing and reviewing regulatory submissions (INDs, CTAs/IMPD-Qs, or BLAs)
• Familiarity with QbD development framework

TRAVEL REQUIREMENTS

• This position may require minimal travel (up to 10%)

• Manage a team of process engineers developing best-in-class AAV manufacturing processes
• Develop and clearly communicate team goals, aligned with CMC and corporate objectives
• Manage and mentor team members; provide feedback and coaching for individual development
• Manage the daily operation of the team, including delegation of tasks
• Provide hands-on technical oversight of development activities
• Design and execute AAV process optimization and characterization studies, providing expertise and presenting results in cross-functional interactions
• Contribute to the definition of critical quality attributes and manufacturing control strategies
• Apply Quality by Design principles to build process and product understanding
• Work closely with MS&T to:
• Support technology transfer activities to external CDMO partners
• Provide technical expertise and assist in the review of Batch Records, SOPs, Change Controls, manufacturing campaign summary reports and process validation strategy documents
• Lead technical troubleshooting, and support manufacturing investigations, root cause analyses, CAPAs, impact and risk assessments and change controls
• Work with Analytical Development to develop fit-for-purpose assays and analytical tools to improve process and product understanding
• Develop and diligently manage annual capital and operating budgets
• Lead the planning and production effort for IND-enabling batches at the 50L and 200L scale
• Contribute to the writing and review of US and ex-US regulatory filings and updates
• Ensure development activities are properly documented to enable seamless use as supporting documentation for filings
• Develop and provide technical reports supporting process changes and improvements as well as process characterization/pre-validation
• Remain current with regulatory and scientific advances relevant to the manufacture and process validation of gene therapie