- Play a lead role for core activities during technology transfer of processes into GMP clinical and commercial manufacturing, including on-floor support as Person-In-Plant and authoring and reviewing of technical documents
- Author and review plans, protocols, technical reports and CMC sections of regulatory submissions
- Review and support continuous improvements of manufacturing procedures for pre-commercial and post-commercial lifecycle management of the manufacturing process
- Lead projects to optimize and implement process improvements related to closed and single-use cell therapy manufacture
- Coordinate implementation of process improvements and new process technology into clinical and commercial GMP facilities
- Collaborate with external vendors and internal engineering teams to design and implement novel automation and closed processing technologies for cell therapy production
- Contribute to process characterization and process validation work packages to progress the CMC development of Orca's clinical pipeline
- Participate in investigations and troubleshooting of both manufacturing issues and lab studies
- PhD, MSc in Chemical Engineering, Biotechnology, or related field; candidates with Master's or Bachelor's degree will be considered with additional experience
- 3-7 years of experience (depending on education) in process sciences or manufacturing
- Experience with commercial biologic (e.g., antibody, recombinant protein) processes; cell/gene therapy experience preferred
- Experience with aseptic techniques and closed manufacturing systems
- Experience with late-stage process development, including process characterization and/or process validation preferred
- Experience with regulatory (e.g., IND, BLA) authoring
- Experience with quality risk management (i.e., risk assessments)
- Ability to travel to Sacramento occasionally %)
- Demonstrated organizational, record-keeping, and problem-solving skills, with an attention to detail
- Strong interpersonal skills including verbal and written communication
- Demonstrated success working independently as well as in a team environment
- Ability to act with urgency and agility to bring lifesaving therapies to patients
- Intense curiosity and a propensity to break with the status quo
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Sr. Engineer, Process Development - Sacramento, United States - Orca Bio
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Description
Summary:
The Sr. Engineer/Scientist in Process Development, CMC will focus on commercialization and post-commercial process optimization of allogeneic cell therapy manufacturing processes.
You will contribute to technology transfer into GMP manufacturing, evaluation of replacement and novel raw materials, BLA content generation, scale-up/scale-out, and process/operational optimization to advance Orca's clinical pipeline into commercialization.
This role is expected to closely collaborate with multiple teams across Process Development, MSAT, Analytical Development, Regulatory Affairs, Quality and Manufacturing.
Responsibilities: