Principal Scientist, Analytical Development - Process Science

ImmunityBio, Inc.•Louisville, CO

1d•$150,000 - $165,000•Onsite

About The Position

The Principal Scientist, Analytical Development - Process Sciences will collaborate with internal and external partners to develop, qualify and implement methods across ImmunityBio’s platforms and advance our pipeline. This role will serve as a key technical leader and mentor within the Process Sciences department, driving innovation in method development and characterization from early-stage development through late-stage commercialization. The Principal Scientist will support TechOps management and Regulatory Affairs personnel with regulatory filings and provide guidance and consultation to members of the Manufacturing, Quality Assurance, Quality Control, and Process/Product Development teams while overseeing timely execution of samples in support of process development activities.

Requirements

Ph.D. in Chemistry, Biochemistry, Molecular Biology or related scientific field with 6+ years of relevant experience in the biopharmaceutical industry required; or MSc in Chemistry, Biochemistry, Molecular Biology or related scientific field with 9+ years of relevant experience in the biopharmaceutical industry required; or Bachelor’s degree in Chemistry, Biochemistry, Molecular Biology or related scientific field with 12+ years of relevant experience in the biopharmaceutical industry required.
Extensive experience in method development, method validation, and method transfer is required.
Previous supervisory experience strongly preferred
Expert knowledge of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF
Working knowledge of biological assays including ELISA, cell-based potency assays, and flow cytometry
Familiarity with formulation development is required, hands-on experience with formulation development is highly desired
Demonstrated ability to translate complex analytical data into actionable insights for cross-functional process development, manufacturing, quality assurance and quality control teams
Self-motivated and willing to accept temporary responsibilities outside of initial job description
Excellent interpersonal, verbal and written communication skills
Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based upon changing priorities
Strong project management skills. Able to manage multiple projects in parallel, including key participation on multi-disciplinary project teams
Strong statistical analysis skills
Strong technical writing skills with experience reviewing and approving: SOPs, analytical test methods, qualification and validation protocols/reports, summary reports, and CMC sections of FDA and EMA filings

Nice To Haves

hands-on experience with formulation development is highly desired

Responsibilities

Lead the design, development and qualification of robust analytical methods for therapeutic proteins, viral vectors and whole cell products. This includes chromatography, electrophoresis, and cell-based or binding bioassays
Lead method transfer activities ensuring seamless transfer of assays to and from Quality Control or external Contract Development and Manufacturing Organizations
Manage the day-to-day activities of the team to include the hiring and training of new team members, coaching employees and monitoring performance
Serve as principal technical subject matter expert (SME). Provide mentorship, training and strategic guidance to less junior team members, fostering a collaborative and high-performing laboratory culture
Author and review high-quality technical reports, protocols, validation plans, and CMC sections for regulatory submissions (IND/BLA). Ensure all activities align with ICH guidelines and USP/EP compendial requirements
Collaborate with and monitor contract testing laboratories and consultants, ensuring compliance with company procedures
Perform and guide others in a variety of HPLC and Biochemistry techniques including SEC, RP, IEX SDS-PAGE, CE and icIEF to assess product quality and characterize products
Perform formulation and stability support by performing force degradation studies
Advise and support efforts for method troubleshooting remediation, change, and optimization efforts in conjunction with Quality Control
Lead support activities for the Process Development teams to characterize process improvements and develop new products
Oversee the maintenance, calibration and operation analytical equipment and instruments
Perform ad-hoc and cross-functional duties and/or projects, as 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