Associate Director, Process Development

About the company

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.

• Advance innovative science by pushing boundaries.
• Bring transformative therapeutics to patients in need.
• Provide an environment for employees to reach their fullest potential.

• Be a Pioneer. We are not afraid of the impossible and 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.

About the role

The Associate Director, Process Development is a key position in the Cell Line & Process Development team, liaising between the development arms while serving as a subject matter expert (SME) for novel recombinant adeno-associated virus (rAAV) vector platform development. This position evaluates new cell lines in scale-down models, develops end-to-end processes for production and purification with these novel cell substrates, and recommends forward-looking GMP activities based on development data. This position is onsite at the BioPoint, RTP, NC facility, reporting to the VP of Cell Line & Process Development.

Responsibilities

• Lead a team of Research Associates and Scientists responsible for developing viral vector manufacturing processes, scale-up, and internal technology transfer.
• Manage end-to-end platform development for novel rAAV producer cell lines applying statistical approaches for experimental execution and optimization.
• Oversee internal qualifications of GMP cell banks and critical raw materials in vector manufacturing processes.
• Partner with MSAT on life cycle management of clinical program manufacturing and optimization.
• Lead platform fit and/or development activities for portfolio programs, as needed.
• Identify and develop new technologies for increased productivity, recovery, product quality, and/or improved cost of goods.
• Collaborate cross-functionally with other AskBio teams inside and outside of Technical Operations, including partner CDMOs.
• Develop internal tech transfer documents and author/review CMC regulatory documents.
• Review and communicate experimental results both orally and in written reports/presentations to colleagues, senior management, and at external partners and conferences.
• Identify CapEx needs, develop corresponding budget and justification.
• Assist with the development of and adherence to department budgets.
• Identify and execute against personnel plans, including hiring, training, and development in the pursuit of organizational objectives.
• Contribute to intellectual property strategies and manage staff to successful IP support.
• Author technical and development documents, including relevant sections in regulatory submissions.
• Mentor and develop team members by establishing a collaborative and growth-minded culture that encourages personal and professional development.
• Present scientific data at internal forums and external conferences.

Requirements

• Master’s Degree in a scientific or engineering discipline with a minimum of eight years of relevant work experience.
• Prior experience managing cross-functional teams of Research Associates, Scientists, and/or Engineers.
• Prior experience with recombinant AAV and/or extensive experience in biologics employing relevant unit operations.
• Strong understanding of mammalian cell biology, engineering principles, and how to interconnect them.
• Self-motivated leader with a track record of novel development of biologics demonstrated through publications, patents, posters, and/or presentations.
• Functional expertise in design of experiments (DOEs) and Quality by Design (QbD) approaches.
• Excellent written and verbal communication skills.
• Good working knowledge of Microsoft Office suite (Word, Outlook, Excel) and statistical analysis software.

Preferred Qualifications

• PhD in a scientific or engineering discipline.
• Cell line development for the production of AAV, antibodies, or recombinant protein.
• Strong working knowledge of Benchling, QbD Vision, and/or JMP.