Director, Pre-Clinical Manufacturing

Ask Bio 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.

Ask Bio’s gene therapy platform includes Pro
10, 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.  We hold 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 Ask Bio’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 work streams 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…