Associate, Bioprocess Development

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.

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.

The anticipated annual salary range for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations. Who we are We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them. We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility. We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo. We maintain a start-up culture of camaraderie and leadership by example, regardless of title. We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers. Notice to staffing firms Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.