Position SummaryThe Director, Pre-Clinical Manufacturing is a critical member of the Preclinical Manufacturing team in AskBio's RTP facility and will report to the Vice President of Preclinical Manufacturing (PCM) & Manufacturing Science and Technology (MSAT). The strongest candidate would combine hands-on bioprocess credibility with the ability to construct a reliable operating system for supplying multiple preclinical programs ranging from small-scale early research products to large-scale toxicology batches. A suitable candidate must possess a strong understanding of upstream and downstream vector production, plasmid DNA supply, analytical release testing, technology transfer, process robustness, manufacturing scheduling, and the transition from research-grade material to IND-enabling and GMP production
The role will act as a Subject Matter Expert (SME), technical expert, and mentor, to oversee several concurrent workstreams including: all production and purification aspects of small-scale plasmid production and supply, small-scale (610L) supply of high-quality recombinant AAV vectors for research purposes, medium (50L-250L) vector supply laboratory supply for Toxicology-quality AAV vector supply, and building-wide solutions and lab consumables supply.
As a leader of the PCM team, this role will identify, vet, and lead operational excellence programs to improve overall capabilities and cost-effectiveness of the team as well as how the work product of this team meets the needs of customer groups such as R&D, PD, and MSAT.
This role will also act as a technical consultant and guide for our R&D, PD, and MSAT teams as they advance and refine our product pipeline for product quality, manufacturability, and commercial viability.
Job Responsibilities- Translate the research and development portfolio into a coherent manufacturing strategy, including material requirements, production pathways, capacity assumptions, sourcing decisions, and program priorities.
- Manage an ever-changing pipeline demand into feasible production schedules to balance urgency, manufacturing capacity, raw materials, equipment, analytical testing, staffing, and release timelines across multiple programs
- Wield substantial knowledge in the areas of cell culture, transfection, harvest, clarification, purification, concentration and formulation, as well as vector-specific quality attributes and impurities or overcome challenges
- Oversee a team that maintains the lab and solutions supplies for Pre-Clinical Manufacturing, Process Development, and MSAT teams in a manner that balances supply assurance while minimizing waste and cost
- Work closely with project management teams to establish project timeline and ensure work is completed according to the program timeline.
- Work with internal partners to create and maintain comprehensive project documentation, plans and progress reports. Generate and update project communication presentations to ensure stakeholder alignment
- Oversee a team that supplies small-scale plasmid supply for internal research and development purposes. Supply should be maintained in an efficient and cost-effective manner
- Oversee the coordination of shipping and receiving of rAAV and DNA.
- Guide development of scalable AAV operations, process optimization, impurity clearance, raw-material simplification, yield and cost improvement, and preparation of technologies that can ultimately be implemented at commercial scale
- Support development of procedures and documentation systems to successfully perform specific unit operations in the production and characterization of plasmid DNA and rAAV vectors
- Mentor junior staff by planning and assigning short-term and long-term goals to meet organizational objectives
- Develop and maintain laboratory budgets are fiscally responsible and cross-department charges are managed appropriately
- Create a development plan to ensure retention and long-term growth of the team
- Develop, manage, and oversee operational excellence programs to ensure continuous improvement within and between departments
- Develop and maintain a strong partnership with Quality Assurance to ensure work streams maintain or exceed Quality and regulatory expectations
Minimum Requirements- Bachelor's degree in Chemical Engineering, Biochemistry, Biology or a relevant scientific or engineering discipline with10+ of hands-on industrial pharmaceutical or biotechnology experience
- Strong leadership experience, managing teams of scientists and associates
- Experience in the manufacturing of the biologics (mAb, recombinant protein, vaccine, or viral vector)
- Hands-on experience of mammalian cell culture, depth flow filtration (DFF), chromatography, tangential flow filtration (TFF), and other relevant unit operations to produce the vectors
- Technical writing skills with experience authoring/reviewing protocols, reports, SOPs, and batch records
- Significant experience with complex statistical analyses and associated software such as JMP or R
- Excellent written and verbal communication skills
- Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders
- Strong team player who works closely and effectively with cross-functional organization
- Strong attention to detail
Preferred Education, Experience and Skills- Experience with or knowledge of GMP quality
- Advanced degree in relevant scientific or engineering field
- GLP grade and/or GMP grade biologics manufacturing experience
- Experience producing rAAV viral vectors in an industry setting
