Associate Director, Process Development

AskBio Inc.; Durham (NC); On-site; USD 150,000 - 210,000; Full time

Job summary

AskBio Inc. in Research Triangle Park, NC, is seeking an Associate Director, Process Development to lead viral vector manufacturing process development and scale-up.

You will oversee end-to-end platform development for novel rAAV producer cell lines, applying DOE-based optimization and QbD approaches. You will mentor a team of researchers, coordinate cross-functional efforts with MSAT and other groups, and contribute to regulatory documentation and tech transfer.

Qualifications

• Master’s Degree in a scientific or engineering discipline with at least eight years of relevant work experience.
• Experience managing cross-functional teams of Research Associates, Scientists and/or Engineers.
• Experience with recombinant AAV and/or biologics unit operations.
• Strong understanding of mammalian cell biology and engineering principles.
• DOEs and QbD approaches; publications or patents a plus.
• Excellent written and verbal communication; MS Office and stats software.

Responsibilities

• Lead a team of researchers responsible for developing viral vector manufacturing processes and technology transfer.
• Manage end-to-end platform development for novel rAAV producer cell lines using DOE-based optimization.
• Oversee GMP cell banks qualifications and raw materials in vector manufacturing.
• Collaborate with MSAT on life cycle management of clinical program manufacturing.
• Develop internal tech transfer documents and author CMC regulatory submissions.
• Present results to colleagues, senior management and external partners.

Skills

Cross-functional leadership

AAV knowledge

Mammalian cell biology

Design of experiments (DOE)

Quality by Design (QbD)

Scientific communication

Statistical analysis

Education

Master's degree in science/engineering

PhD in science/engineering

Tools

Benchling

QbD Vision

JMP

Microsoft Excel/Office

Job description

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.

Position Summary

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.

Job Responsibilities

• Lead a team of Research Associates and Scientists responsible for developing viral vector manufacturing processes, scale-up, and internal technology transfer
• Management of 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 our 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
• Identifes CapEx needs, develops corresponding budget and justification
• Assists with the development of and adherence to department budgets
• Identifies and executes against personnel plans, including hiring, training, and development in the pursuit of organizational objectives
• Contributes to intellectual property strategies and manages staff to successful IP support
• Author technical and development documents, including relevant sections in regulatory submissions
• Mentors and develops 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

Minimum 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 Education, Experience And Skills

• 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

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 [e-mail].