Associate, Bioprocess Development

Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

Position Summary:

You will focus on developing a process for antibody and antibody conjugate manufacturing, and facilitating tech transfer. You will jointly manage a GMP clean room in Menlo Park, CA, including equipment maintenance, inventory, logbook management and so on. You will perform process development and engineering runs in a GMP environment, contribute to process design, troubleshooting, scale-up/scale-out, assay development, and technology transfer to advance Orca’s clinical pipeline from first-in-human through commercialization. This role collaborates closely with members of the manufacturing, quality, facilities, and supply chain teams.

Essential Duties & Key Responsibilities:

• Bridge development and manufacturing activities by translating process learnings into robust, executable procedures, batch records, and tech transfer documentation.
• Perform development and engineering runs according to written procedures in a GMP environment.
• Perform investigations on process & product deviations for continuous process improvement.
• Help to manage a GMP clean room following Orca internal procedures. Share responsibility for equipment maintenance and calibration, inventory, environmental monitoring, and logbook management.
• Perform experiments and assays which increase process understanding and control.
• Help to perform stability and formulation studies.
• Collaborate with external vendors and internal teams to design and implement novel technologies for manufacturing, development, and tech transfer.
• Support continuous improvements of records and follow the operating procedure with strong attention to details.
• Maintain detailed records of experiments. Practice good data management and documentation habits.
• Organize and present data in a manner that is easily understood by other team members in lab notes, reports, and presentations.
• Closely collaborate with Orca teams across manufacturing, quality control, quality assurance, analytical development, and others.

Required Qualifications:

• Bachelor’s degree in Chemistry, Chemical Engineering, Biotechnology, Biochemistry, or related field with 2-5 years of experience in process sciences, or manufacturing science and technology experience.
• Master’s degree in one of the above fields with 1-3 years of process sciences or manufacturing science and technology experience preparing biologics.
• Willingness to work in a BSL-2 environment and handle human blood samples
• Willingness to learn flow cytometry and cell staining techniques for analysis of cell populations. Prior experience is a plus.

Preferred Qualifications:

• Experience with protein expression and purification workflows
• Experience with techniques for protein characterization
• Competence in aseptic technique and mammalian cell culture
• Experience preparing and characterizing protein conjugates
• Familiarity with FPLC instruments
• Experience preparing and analyzing plasmid DNA and performing transformations and transfections

Professional Qualities:

• Clear and effective communicator and listener
• Detail oriented and organized
• Writes clearly and concisely
• Takes ownership and responsibility for tasks
• Strives to learn new things
• Comfortable working in both exploratory development settings and highly controlled GMP manufacturing environments

Travel Requirements:

• Travel to Orca’s Sacramento manufacturing facilities as-needed.