Director, Upstream Process Development

4 weeks ago

Boston, United States Oxford Biomedica Full time

We use science to save lives, and so can you.


We are currently recruiting for a Director of Upstream Process Development to join our Process Development group. The purpose of this role is to lead the Upstream Process Development team responsible for upstream platform development (including cell line, media, bioreactor process, plasmid transfection, and cell lysis), process optimization, process characterization, and process scale-up and transfer to GMP manufacturing. This onsite role is based in Bedford, MA. Come join the team, and let's do something life-changing, together


Our Process Development (PD) Group is composed of four functions including Vector Engineering, Upstream Process Development, Downstream Process Development, and Drug Product Sciences, supporting viral vector construct design and screening, process and formulation development and characterization, technology transfer to GMP manufacturing, and material generation for research and toxicity studies.


Your responsibilities in this role would be:


  • Oversee a group of scientists and research associates and provide technical guidance and support to ensure the successful execution of upstream process associated activities.
  • Lead the innovation, development, optimization, and characterisation of upstream processes for the production of viral vectors including AAV and LVV.
  • Initiate and lead collaborations with other PD and AD (Analytical Development) functions.
  • Lead cross-functional team, including PD, AD, MSAT, manufacturing, quality etc. to ensure efficient and successful scale-up and transfer of internal or external processes to internal GMP manufacturing.
  • Define and execute the upstream process development plan, including the selection of key technologies and process control strategies, and the design and execution of experiments.
  • Provide technical support to the manufacturing team to troubleshoot process-related issues and ensure product quality and productivity.
  • Provide strong technical and strategic contributions to cross functional project teams.
  • Author or review associated CMC regulatory filing documents.
  • Collaborate with external clients and suppliers to advance process capabilities and technologies.
  • Prepare and present technical reports and presentations to internal and external stakeholders.


We are looking for:


  • PhD/MS/BS in Biochemical Engineering, Chemical Engineering, or a related field and a minimum of 10-year industry experience. Reputation as emerging leader in field with sustained performance and accomplishments.
  • Hands-on experience in upstream process development and process characterization in the biotechnology industry, with a focus on viral vector production.
  • Strong leadership and management skills, with the ability to effectively lead and motivate a team of scientists and engineers.
  • Proven track record of successful process development, scale-up, and process characterization in the biotechnology industry.
  • Excellent technical skills and understanding of process development, process scale-up and scale-down, process characterization, tech transfer, and GMP manufacturing
  • Strong communication and presentation skills, with the ability to effectively convey technical information to cross-functional teams and external stakeholders.
  • Able to effectively manage and prioritize multiple parallel activities is essential
  • Independently motivated, highly organized, detail oriented and excellent problem-solving ability


About Us:

We are a quality and innovation-led cell and gene therapy CDMO with a mission to enable our clients to deliver life changing therapies to patients around the world.

Our innovative solutions and proven expertise allow our clients in the biotech and biopharma industry, to deliver life-saving therapies to reach even more patients.

The success of cell and gene therapy products transforms outcomes for millions of people suffering from some of the world’s worst diseases and medical conditions.


What’s in it for you:


  1. Competitive reward packages
  2. Development opportunities
  3. Welcoming, friendly, supportive colleagues
  4. A diverse and inclusive working environment
  5. State of the art laboratory and manufacturing facilities


We want you to feel inspired every day. We’re future-focused and our business is growing rapidly. We succeed together through passion, commitment and teamwork, and so can you.


Collaborate. Contribute. Change lives

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