Associate Director, MSAT

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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. 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. The Associate Director, Manufacturing Science and Technology (MSAT) will be responsible for aspects of tech transfer, readiness, and implementation of AskBio's portfolio of gene therapy products into cGMP manufacturing from clinical production through commercial launch. The scope of the role includes manufacturing technology implementation and technical stewardship, technology transfer at GMP manufacturing scale, process optimization, small scale model development, process characterization & validation, and partnering to develop a life cycle management process for commercial drug substance and drug product manufacturing. This position will work closely with Process and Analytical Development, Quality Control, Quality Assurance, Manufacturing Operations, Supply Chain, and Regulatory teams, both within AskBio and with AskBio's manufacturing partners to define global process technology and manufacturing strategies, ensuring continuity of supply and adherence with global regulations and standards. This position will be office-based in RTP, NC and will report to the Vice President, Preclinical Manufacturing & Manufacturing Science and Technology . Job Responsibilities Mentor and guide cross-functional team(s) on all aspects of technology transfer of gene therapy processes from process development into the MSAT laboratory and then into cGMP production Use your knowledge of the Design of experiment (DOE) methodology to design optimization programs and guide teams as they manage process optimization campaigns Develop a strategy for a risk-based small-scale model development campaign that is predictive of manufacturing and enables process characterization. Mentor teams on the development of a risk-based process characterization campaign that maximizes the value of study results to support a PPQ-ready process control strategy. Lead the PPQ/Process Validation campaign for an AskBio gene therapy product including preparation of validation master plans, risk assessments, protocols and reports. Provide oversight of PPQ and Process Validation execution. Lead the development of a Continuous Process Verification plan for an AskBio gene therapy product including establishing trending, and annual reporting systems. Use your upstream and/or downstream biomanufacturing experience and technical understanding of cGMP manufacturing operations to design and guide continuous improvement projects, in partnership with process development and external manufacturing in order to improve manufacturability, reliability, yield and cost. Support equipment and reagent supplier technical evaluations, risk assessments, and raw material evaluation and qualification. Set standards for technical protocols and reports to support experimental work while ensuring your team maintains organized electronic laboratory notebooks. Review and approve documents and ensure suites of documents are suitably ali

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