R&D Leader, rAAV Process Development

AskBio Inc.; Nouvelle-Calédonie; Sur place; EUR 155 000 - 207 000; Plein temps

Résumé du poste

AskBio Inc. seeks an Associate Director, Process Development to lead the Cell Line & Process Development team and serve as SME for novel rAAV platforms. You will drive end-to-end production and purification processes and define GMP activities based on development data.

Onsite at BioPoint, RTP, NC, you will mentor staff, manage tech transfer, and collaborate with MSAT, CDMOs, and internal teams to support regulatory submissions.

Qualifications

• Master’s degree in a scientific or engineering field with at least eight years of relevant experience.
• Experience leading cross-functional Research/Engineering teams.
• Experience with recombinant AAV or biologics process development.
• Strong mammalian cell biology and engineering fundamentals.
• Proven DOEs and QbD application.
• Excellent written and verbal communication.
• Proficient in MS Office and statistical software.

Responsabilités

• Lead a team of Researchers and Scientists in developing viral vector manufacturing processes, scale-up, and technology transfer.
• Oversee end-to-end platform development for novel rAAV producer cell lines using DOE/QbD approaches.
• Manage GMP cell bank qualifications and critical raw materials in vector manufacturing processes.
• Collaborate with MSAT on lifecycle management of clinical program manufacturing and optimization.
• Lead platform fit and development activities for portfolio programs as needed.
• Identify and develop new technologies for productivity, recovery and cost of goods.
• Collaborate with internal and external teams including CDMOs; develop tech transfer docs and regulatory submissions."
• Mentor and develop team members, promoting growth and collaboration.

Connaissances

Leadership

DOE & QbD

Communication

Statistics

Office tools

Formation

Master’s degree + 8+ years experience

PhD preferred

Outils

Benchling

QbD Vision

JMP

Description du poste

AskBio Inc. seeks an Associate Director, Process Development to lead the Cell Line & Process Development team and serve as SME for novel rAAV platforms. You will drive end-to-end production and purification processes and define GMP activities based on development data.

Onsite at BioPoint, RTP, NC, you will mentor staff, manage tech transfer, and collaborate with MSAT, CDMOs, and internal teams to support regulatory submissions.