Scientist I, Research &Development

ImmunityBio•Louisville, CO

1d•Onsite

About The Position

The Scientist I position will aid in the development and generation of new novel therapeutics/vaccines intended for pre-clinical and cGMP-manufacturing use. The role is responsible for performing research and development work related to numerous expression system-based immunotherapies, including viral vector platforms and mRNA. The role will primarily be involved with the cloning of new gene-therapy vectors, subsequent vector characterization, cell culture optimization, and troubleshooting issues related to such pre-clinical manufacturing processes. The Scientist I will perform bio-assay development experiments, careful documentation of methods and materials and results, writing technical reports, and effectively communicating findings to other teams. This role is also responsible for aiding in the design and execution of product development experiments that lead to a robust and scalable clinical and commercial production process.

Requirements

Bachelor’s degree in Cell Biology, Microbiology, Biology, or other life science or related field with 10+ years of experience including direct experience in upstream and/or downstream processes
Master’s degree in Cell Biology, Microbiology, Biology, or other life science or related field with 8+ years of experience in biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes required
PhD degree in Cell Biology, Microbiology, Biology, or other life science or related field with 1+ experience in biopharmaceutical-based process development and/or GMP manufacturing operations including direct experience in upstream processes preferred.
Experience with molecular cloning, human tissue culture, and viral vector construction required
Experience working with viruses in a BSL-2 viral laboratory required
Experience in molecular biology/cloning, RNA biology, cell biology, tissue culture and cell-based methods, with a proven track record of achievement required
Strong initiative, problem solving, attention to detail, ability to effectively organize and prioritize are required.
Ability to work with Quality and Manufacturing groups to ensure a compliant manufacturing environment and work collaboratively with other team members to support the transfer of biological drug processes from R&D/Product Development to Manufacturing.
Adapts to rapidly changing work environment and shift in priorities.
Possess good interpersonal and strong written/verbal communication skills.
Manage multiple assignments and processes with excellent skills in prioritizing and time management.
Possess the ability to multitask and work independently or in a team environment with minimal supervision.
Good computer skills in word processing, spreadsheets, and database software applications, including MS Office (Word, Excel), Visio and statistical software including JMP.
Strong aptitude for problem solving, technical writing and ability to effectively participate on teams.
Possess a high level of honesty and integrity, highly motivated and detail-oriented.
Comfortable/Willing to work with small rodent research animals

Responsibilities

Support Research and Development projects designed to generate pre-clinical material characterization, design of experiments (DOE), and defining critical process parameters.
Identify and propose process optimization, continuous improvement projects and support initiatives.
Support scale-up and technology transfer of new products and processes into cGMP manufacturing.
Apply analytical skills to evaluate and interpret complex issues and data sets utilizing multiple sources of qualitative information and quantitative research.
Support product specific data trending programs.
Author and review technical protocols/reports, tech transfer documents, SOPs and MBRs.
Lead and participate in team meetings and present results intra- and interdepartmentally.
Provide support and technical insight for process-related issues and investigations, including non-conformance product impact assessments, root cause analysis, change control, and process optimization.
Design and execute experiments, and compile results/statistical data analysis for scaled-down lab processes to enable process troubleshooting, support process robustness and characterization studies, and develop process improvements
Bench-scale study ownership including the collection and interpretation of data from bench scale experiments with minimal oversight.
Conducts daily tasks associated with development and characterization of novel human therapeutics.
Responsible for laboratory equipment maintenance programs.
Meticulously maintains experimental records with detailed observations.
Conducts additional laboratory work and projects, as needed.
Support preclinical studies by evaluating basic health status of animals and reporting abnormalities to the appropriate personnel
Support the lab by performing activities such as maintaining lab equipment, ordering and stocking supplies, and maintaining inventory
Performs 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