The Manager, Upstream Pre-Clinical Manufacturing oversees the production of research and GLP-grade recombinant Adeno-associated virus (rAAV) vectors. Reporting to the Director of Pre-Clinical Manufacturing, this role guides cross-functional teams in the successful delivery of vectors supporting early-stage gene therapy programs—from proof-of-concept through GLP-tox material supply.

The Manager translates functional strategies into actionable operational processes, optimizing resource allocation to meet aggressive timelines while ensuring high-quality data generation for capsid technology and therapeutic portfolios. Additionally, this role establishes department-wide procedures to enhance efficiency and ensures the seamless execution of both small and large-scale manufacturing campaigns.

This position is on-site in RTP,NC.

Job Responsibilities

• Manage upstream manufacturing activities, determining resource requirements and scheduling to meet preclinical program timelines. Partner with management to forecast manufacturing strategies and timelines that support early-stage development through GLP-tox material supply.

• Lead risk-based process characterization and improvement initiatives to optimize product yield and scalability. Oversee the successful transfer of new processes into vector manufacturing, performing risk assessments and identifying mitigations during transfer of new technologies.

• Mentor and manage a technical team of manufacturing personnel, fostering a culture of technical excellence and accountability. Provide expertise in upstream operations (cell culture, WAVE, and stirred-tank bioreactors) and provide hands-on instruction or execution of manufacturing activities, as required.

• Oversee the issuance, review, and approval of all manufacturing documentation, including batch records, investigations, protocols, reports, and SOPs. Ensure high standards of data integrity are maintained through organized electronic laboratory notebooks and rigorous report review.

• Identify areas for process improvement, lead root cause analysis for manufacturing failures, and oversee the implementation of corrective actions. Develop and manage operational initiatives to improve business processes and department-wide efficiency.

• Ensure the laboratory is maintained in efficient working order by coordinating equipment maintenance/calibration, raw material inventory, and overseeing the strategic planning of supplies in partnership with lab operations and supply chain personnel.

• Track and evaluate manufacturing metrics and analytical results to determine potential sources of process variability and drive process updates to improve operational consistency.

• Act as a key technical contact for cross-functional stakeholders, preparing internally reviewed reports and delivering technical presentations to internal and external leadership.

• Bachelors Degree in Science or Engineering discipline (Chemical Engineering, Biochemical Engineering, Biotechnology, Biology, Chemistry, Biochemistry, or equivalent) with minimum of 8 years relevant industry experience or Masters with 6 years industry experience,

• Experience in bioprocess manufacturing or laboratory research, preferably in rAAV and/or recombinant protein/biomolecule bioprocess manufacturing, and a desire to continue in a laboratory-focused role. Experience with process develop and/or supporting analytics is a plus.

• Knowledge and experience with upstream or downstream process operations, such as cell culture, centrifugation, depth filtration, tangential-flow filtration, and/or chromatography with expertise in at least one functional area is required.

• Proven ability to manage and train a technical team and deliver results in a fast-paced, team-oriented laboratory environment.

• Excellent written and verbal communication, work planning, data analysis, and record keeping skills (with strong attention to detail) is required

• Demonstrated ability to generate results and innovative solutions independently and solicit buy-in from leadership

Preferred Education, Experience and Skills

• Problem Solving & Analysis: Advanced troubleshooting skills for complex technical issues, with the ability to lead root cause analysis and implement effective corrective actions

• Self-motivated and highly organized, with a demonstrated ability to manage and re-prioritize group workloads to ensure departmental and project goals are met

• Experience working within a highly collaborative, cross-functional environment, with the ability to solicit buy-in from leadership and partner effectively with internal and external stakeholders.

• Familiarity with JMP Statistical Software and the ability to guide others in its application for data analysis, trend analysis, and process monitoring.

• Deep technical understanding of the gene therapy landscape, specifically regarding rAAV vector manufacturing and upstream process operations.

• Advanced proficiency in the Microsoft Office suite (Word, Excel, PowerPoint, Outlook) for data presentation and organizational communication. Familiarity with electronic notebook systems and scheduling tools a plus.