Principal Scientist, Upstream Process Science

ImmunityBio • Louisville, CO

2d • Onsite

About The Position

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.

Requirements

• 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.
• Extensive experience in method development, method validation, and method transfer is required.
• 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

Nice To Haves

• Previous supervisory experience strongly preferred

Responsibilities

• 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.

Benefits

• Medical, Dental and Vision Plan Options
• Health and Financial Wellness Programs
• Employer Assistance Program (EAP)
• Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
• Healthcare and Dependent Care Flexible Spending Accounts
• 401(k) Retirement Plan with Company Match
• 529 Education Savings Program
• Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
• Paid Time Off (PTO) includes: 11 Holidays
• Exempt Employees are eligible for Unlimited PTO
• Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree