Director, Downstream Process Development, US

oxfordbiom•New Bedford, MA

30d•Onsite

About The Position

At OXB, our people are at the heart of everything we do. We’re on a mission to enable life-changing therapies to reach patients around the world—and we’re looking for passionate individuals who embody our core values every day: Responsible, Responsive, Resilient, and Respectful. We are currently recruiting for an Associate/Director, to join and lead the Downstream Process Development team OXB located at our Bedford, MA facility. This role plays critical part in developing, optimizing, and scaling downstream processes, guiding the team in delivering robust and efficient process development solutions to our clients, playing a key part in advancing our mission and making a real difference. OXB is a quality and innovation-led viral vector CDMO (Contract Development and Manufacturing Organization) with a mission to enable its clients to deliver life-changing therapies to patients around the world. One of the original pioneers in cell and gene therapy, we have more than 30 years of experience in viral vectors; the driving force behind the majority of gene therapies. OXB collaborates with some of the world’s most innovative pharmaceutical and biotechnology companies, providing viral vector development and manufacturing expertise in lentivirus, adeno-associated virus (AAV) and adenoviral vectors. OXB’s world-class capabilities span from early-stage development to commercialisation. These capabilities are supported by robust quality-assurance systems, analytical methods, and depth of regulatory expertise.

Requirements

BS (10+), MS (8+), or PhD (6+) years industry experience.
Degree in microbiology, biochemistry, biotechnology, chemical engineering, or molecular biology.
Hands-on experience in viral vector process development, scale-up, tech transfer, and manufacturing support.
Experience in unit operations including clarification, capture and polishing chromatography, and UF/DF.
Experience with downstream process development and characterization following QbD principles.
The ability to create strategy, implement, lead and manage a team of scientists and research associates to work in a fast-paced, highly collaborative environment.
Strong communication and presentation skills, with the ability to effectively convey technical information to cross-functional teams and external stakeholders.
Proven experience within a customer centric environment.

Responsibilities

Lead a team of Research Associates and Scientists in AAV downstream process development. Mentor, coach, and provide career development opportunities aligned with individual team members and company goals.
Establish and implement strategies to enhance and continuously improve OXB’s Downstream Process Development platform, ensuring delivery of efficient, scalable, and high-quality processes and products to clients.
Partner closely with Upstream Process Development, Drug Product Development, Analytical Development, and other cross-functional teams to align on shared goals and priorities, optimizing the end-to-end development process while delivering on the pipeline. Provide technical support to cGMP manufacturing as needed.
Serve as a key point of contact for clients, presenting technical data and updates to cross-functional stakeholders, both internally and externally. Cultivate strong relationships with client teams to support the success of their programs.
Leverage expertise in Chemistry, Manufacturing, and Controls (CMC) to drive the development, scale-up, and tech transfer of AAV downstream processes. Ensure all processes meet quality and regulatory standards to support clinical and commercial production.