Director, Pre-Clinical Manufacturing

AskBio Inc., a wholly owned and independently operated subsidiary of Bayer AG, is a fully integrated gene therapy company dedicated to developing life-saving medicines and changing lives. The company maintains a portfolio of clinical programs across a range of neuromuscular, central nervous system, cardiovascular, and metabolic disease indications with a clinical-stage pipeline that includes investigational therapeutics for congestive heart failure, limb-girdle muscular dystrophy, multiple system atrophy, Parkinson’s disease, and Pompe disease. AskBio’s gene therapy platform includes Pro10™, an industry-leading proprietary cell line manufacturing process, and an extensive array of capsids and promoters. With global headquarters in Research Triangle Park, North Carolina, and European headquarters in Edinburgh, Scotland, the company has generated hundreds of proprietary capsids and promoters, several of which have entered pre-clinical and clinical testing.

Our vision: Pioneering science to create transformative molecular medicines.

Our mission: Lead innovative science and drive clinical outcomes to transform people's lives.

Our principles:

• Advance innovative science by pushing boundaries.

• Bring transformative therapeutics to patients in need.

• Provide an environment for employees to reach their fullest potential.

Our values:

• Be a Pioneer. We are not afraid of the impossible and to innovate to make gene therapies accessible to those in need.

• Cultivate Collaboration. Strive to be the best teammate, actively listen, openly communicate, and embrace diverse points of view.

• Embrace Responsibility. We are humbled by the enormity of our mission. Wehold a relentless commitment to advance science and clinical outcomes for our patients, families, and caregivers.

• Raise the Bar. Continuously drive improvements and efficiencies. Seek and provide constructive feedback. Have a bias for learning and action.

• Act with Uncompromising Integrity. Be honest, transparent, and committed to doing what’s right in every situation. Make clear commitments and follow through.

Position Summary

The 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 (≤10L) 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

AskBio Inc. (AskBio) is an Equal Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status or any other protected status prohibited under Federal, State or local laws. All employment decisions are based on valid job-related requirements. If you are a qualified individual with a disability or a disabled veteran and are unable or limited in your ability to use or access our website, you may request a reasonable accommodation to express interest in a specific opening by calling us at (919) 561-6210 or sending us an email at [email protected].

Agencies: Please do not contact any employee at AskBio about this requisition. Any resume submitted by a recruitment agency to any employee at AskBio, through any medium, will be deemed the sole property of AskBio unless the agency was engaged by AskBio Talent Acquisition team to recruit for that position. All agencies must have a prior executed service agreement with AskBio prior to any search engagement. If a candidate who was submitted outside of the AskBio agency process is hired by AskBio, no fee or payment of any kind will be paid to the agency.