Director, Pre-Clinical Manufacturing

AskBio•Durham, NC

8d•Onsite

About The Position

This role is a secondment opportunity at AskBio, available for a duration determined by leadership at both Bayer and AskBio, typically ranging from one to two years. It offers a chance to broaden experience and contribute to AskBio’s mission of advancing gene therapy. The Director, Pre-Clinical Manufacturing is a key member of the Preclinical Manufacturing team at AskBio’s RTP facility, reporting to the Vice President of Preclinical Manufacturing (PCM) & Manufacturing Science and Technology (MSAT). The ideal candidate will possess both hands-on bioprocess expertise and the ability to establish a robust operating system for supplying various preclinical programs, from early research to large-scale toxicology batches. This includes a strong understanding of upstream and downstream vector production, plasmid DNA supply, analytical release testing, technology transfer, process robustness, manufacturing scheduling, and the transition to IND-enabling and GMP production. The role involves acting as a Subject Matter Expert (SME), technical expert, and mentor for multiple concurrent workstreams, including plasmid production, recombinant AAV vector supply for research and toxicology, and lab consumables. The position will also lead operational excellence initiatives to enhance team capabilities and cost-effectiveness, ensuring the team's output meets the needs of R&D, PD, and MSAT. Additionally, the role serves as a technical consultant to R&D, PD, and MSAT teams to improve product quality, manufacturability, and commercial viability.

Requirements

Bachelor’s degree in Chemical Engineering, Biochemistry, Biology or a relevant scientific or engineering discipline with 10+ 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.

Nice To Haves

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.

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.