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.
$75,000 - $105,000 a year
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.
