Associate Director, Process Development

AskBio Inc.; Durham, Northern (NC, KY); Hybrid; USD 180,000 - 240,000; Full time

Job summary

AskBio Inc. in RTP, NC seeks an Associate Director, Process Development to lead viral vector manufacturing process development and scale-up. You will manage a team of researchers and engineers, oversee GMP cell banks, and collaborate with MSAT on clinical program lifecycle management.

The role requires a Master’s plus eight years in biologics or AAV process development, with DOEs/QbD expertise and strong communication skills. Onsite at BioPoint, RTP, NC; contact [e-mail] for inquiries.

Qualifications

• Minimum eight years of relevant work experience in a scientific/engineering role.
• Experience managing cross-functional teams of researchers/engineers.
• Experience with recombinant AAV or biologics process development.
• Strong DOEs and QbD know-how and design of experiments experience.
• Excellent written and verbal communication skills; familiarity with regulatory documents.
• Proficient in MS Office and statistical software.

Responsibilities

• Lead a team developing viral vector manufacturing processes and scale-up.
• Manage end-to-end platform development for novel rAAV producer cell lines.
• Oversee GMP cell bank qualifications and critical raw materials.
• Collaborate with MSAT on lifecycle management of clinical programs.
• Develop internal tech transfer documents and regulatory submission sections.
• Present data to colleagues, senior management, and external partners.

Skills

Cross-functional leadership

Design of experiments

Quality by Design

Mammalian cell biology

Statistical analysis software

Microsoft Office

Education

Master’s Degree in scientific/engineering discipline

PhD in scientific/engineering discipline

Tools

Benchling

QbD Vision

JMP

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.

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 budgetsIdentifies 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

Equal Employment Opportunity

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 [phone] or sending us an email at [e-mail].

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.

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.