Process Engineer I/II (MSAT)
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. Following the expansion of our US footprint with the acquisition of a new commercial-scale viral vector facility in Durham, North Carolina we have some new opportunities to join us. We’re currently recruiting for a Process Engineer II to join our Manufacturing Sciences and Technology Team (MSAT) team. In this role, you will be responsible for leading the assessment and technology transfer of new manufacturing processes that support clinical and commercial manufacturing playing a key part in advancing our mission and making a real difference.
Requirements
- BS/MS in Engineering or a related field or Biological Science or related field with 0-3 years of experience in a technical engineering role or related areas (or a combination of education and experience)
- Requires 0-3 years of experience in pharmaceutical or biologics industry in process development or manufacturing operations
- Experience in implementing special project(s) related to operational process improvement
- Strong leadership, relationship management, and organizational planning
- Ability and willingness to learn and adapt skillsets for various areas of MSAT
- Knowledge of cGMP compliance around bioprocess drug substance manufacturing.
- Experience with bioprocess drug substance manufacturing process development and CGMP manufacturing
- Technical expertise in upstream / downstream operations including equipment knowledge and processes, including but not limited to disposable technologies, clarification, chromatography skids, TFFs, formulation processes, final fill, etc.
Nice To Haves
- Experience in monoclonal antibody production and purification process development is a plus
Responsibilities
- Serve as the Downstream (clarification, chromatography, TFF, sterile fill/finish) technical support for the vector manufacturing process in MSAT Team.
- Technology Transfer Technical Leader for cross functional team
- Leads the introduction of new manufacturing processes and methods to facilitate clinical and commercial manufacturing of multiple cell and gene therapy platform drug substances and products.
- Leads the information transfer and gap assessment of new processes and method transfers.
- Support MSAT and Manufacturing documentation drafting/review with a strong understanding of equipment, critical process parameters, in-process testing, etc.
- Provides guidance and leads facility fit assessments of manufacturing processes in production suites and uses FMEA or similar risk-based approaches to troubleshoot processing issues.
- Author and execute tech transfer plans, engineering studies, risk assessments, technical reports, change controls, and process validation plans/protocols.
- Provides guidance in the documentation of events and deviations during cGMP manufacturing production.
- Provides guidance for process equipment on-boarding.
- May support other tasks as determined by management.
Benefits
- Competitive total reward packages
- Wellbeing programs that support your mental and physical health
- Career development opportunities to help you grow and thrive
- Supportive, inclusive, and collaborative culture
- State-of-the-art labs and manufacturing facilities
- A company that lives its values: Responsible, Responsive, Resilient, Respect
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
