Principal Scientist, Upstream Process Science
$150kImmunityBio, Inc.
Company Overview ImmunityBio is a vertically integrated commercial stage biotechnology company developing next-generation therapies that bolster the natural immune system to defeat cancers and infectious diseases. The Company's range of immunotherapy and cell therapy platforms, alone and together, act to drive and sustain an immune response with the goal of creating durable and safe protection against disease. Designated an FDA Breakthrough Therapy, ANKTIVA is the first FDA-approved immunotherapy for non-muscle invasive bladder cancer CIS that activates NK cells, T cells, and memory T cells for a long-duration response. The Company is applying its science and platforms to treating cancers, including the development of potential cancer vaccines, as well as developing immunotherapies and cell therapies that we believe sharply reduce or eliminate the need for standard high-dose chemotherapy. These platforms and their associated product candidates are designed to be more effective, accessible, and easily administered than current standards of care in oncology and infectious diseases.
Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Upstream Process Sciences role will manage the team responsible for upstream process development, process characterization, and scientific support activities for GMP manufacturing. This role serves as a technical expert for specific unit operations within the upstream manufacturing process, including both microbial and cell culture seed expansions and bioreactor operations across multiple cell lines. This role is also responsible for designing and executing process development experiments to design a robust and scalable clinical and commercial production process. Essential Functions
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Why ImmunityBio? • ImmunityBio is developing cutting-edge technology with the goal to transform the lives of patients with cancer and develop next-generation therapies and vaccines that complement, harness and amplify the immune system to defeat cancers and infectious diseases. • Opportunity to join a publicly traded biopharmaceutical company with headquarters in Southern California. • Work with a collaborative team with the ability to work across different areas of the company. • Ability to join a growing company with professional development opportunities. Position Summary The Principal Scientist, Upstream Process Sciences role will manage the team responsible for upstream process development, process characterization, and scientific support activities for GMP manufacturing. This role serves as a technical expert for specific unit operations within the upstream manufacturing process, including both microbial and cell culture seed expansions and bioreactor operations across multiple cell lines. This role is also responsible for designing and executing process development experiments to design a robust and scalable clinical and commercial production process. Essential Functions
- Lead and advise internal and external teams in development of efficient and robust microbial and cell culture production for whole cell products, viral vector, recombinant monoclonal antibodies, Fc-fusion, and other proteins for research, clinical, and commercial manufacturing.
- Provide high-level technical knowledge in the development of batch, fed batch, and perfusion processes for inoculum expansion and biologics production operations.
- Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
- Provide project coordination and high-level technical expertise in process development, process improvement, scale-up, and tech transfer activities.
- Guide and advise other technical staff in risk assessment, Design of Experiments (DOE), process characterization, process validation, and process monitoring activities.
- Provide input for development programs, and collaborate with discovery, formulation, analytical, quality, regulatory and manufacturing teams.
- Draft, review and approve technical protocols, reports, and manufacturing deviation investigations.
- Present activities and results interdepartmentally, and to senior management.
- Perform ad-hoc and cross-functional duties and/or projects, as assigned, to support business needs and provide developmental opportunities.
- Author and review process-related regulatory submissions.
- Conducts daily tasks associated with development and characterization of novel human therapeutics.
- Responsible for laboratory equipment maintenance programs.
- Create, edit and adhere to Standard Operating Procedures (SOPs).
- Performs ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.
- Ph.D. in Cell Biology, Microbiology, Biology, or other life science or related field with 6+ years of experience in biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required; or
- MSc in Cell Biology, Microbiology, Biology, or other life science or related field with 9+ years of experience biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required; or
- Bachelor's degree in Cell Biology, Microbiology, Biology, or other life science or related field with 12+ years of biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required.
- Previous supervisory experience strongly preferred
- Fundamental knowledge of cell and molecular biology, immunology, and/or virology
- Possess a high level of honesty and integrity, highly motivated and detail oriented.
- Expertise in developing upstream biopharmaceutical production processes.
- In-depth knowledge of statistical design of experiments (DOE) used in process development.
- Master-level technical knowledge of microbial, cell culture, and harvest operations affecting product quality.
- Working knowledge of quality systems related to process development, clinical and commercial manufacturing.
- Excellent communication skills.
- Ability to advise and collaborate with colleagues within and across departments and corporate entities.
- Familiarity with downstream purification operations.
- Adapts to rapidly changing work environment and shift in priorities.
- Possess strong written and verbal communication skills.
- Strong technical writing skills with experience preparing: SOPs, analytical test reports, work instructions, qualification/validation protocols, qualification/validation reports, and summary reports to support FDA and EMA filings
- This position works on site, in Louisville, CO.
- Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.
- This role works in both lab and cleanroom environments.
- Occasional travel may be required, up to 10%.
At ImmunityBio, we are an equal opportunity employer dedicated to diversity in the workplace. Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.
Vacancy posted 4 days ago
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