Specialist, Quality Control Analytical
Company: ImmunityBio
Location: San Diego
Posted on: November 18, 2023
Job Description:
ImmunityBio, Inc. is a late-stage immunotherapy company
developing next-generation therapies that drive immunogenic
mechanisms for defeating cancer and infectious disease. The
company's immunotherapy platform is designed to activate both the
innate (natural killer cell and macrophage) and adaptive (T cell)
immune systems to create long-term "immunological memory." 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 an early-stage public
biopharmaceutical company with a headquarters in Southern
California. * Work with a collaborative team with the ability to
work across different areas at the company. * Ability to join a
growing company with development opportunities. Position Summary
The Specialist, Quality Control Analytical will provide testing
support for the Recombinant fusion protein program through lot
release assays such as Cell-Based Potency assays. The position will
also take on a lead role for one function of the lab, providing
expertise and understanding of the process when needed. The role
will undertake complex laboratory and documentation tasks,
including the creation of in-depth reports and execution of highly
involved testing protocols. Additionally, the position will support
sample preparation teams, complete investigations, and operations
such as cell culture, sample thawing and preparation, lab equipment
preventive maintenance, buffer preparation, supply inventory
management, and general support tasks in order to allow the lab to
continuously operate. Essential Functions
- Leads Potency function of the lab, providing expertise as
needed
- Competent in handling and maintaining mammalian cell culture in
a BSL2 Laboratory is required.
- Provides testing support through In Process, Lot Release and
Stability testing, method transfers, and suitability for use
testing
- Supporting of the Continued Process Verification (CPV) program
for the trending of direct fusion drug products.
- Create and maintain metrics for assay performance and lab
operations
- Completes investigations and other associated analytical
documentation and trending
- Creates in-depth reports and highly involved testing
protocols
- Performs Cell Culture, Lab Maintenance, and Lab Support
Functions including completing maintenance records and cell culture
reports and deliverables
- Critical reagent qualification
- Provides Quality Systems and Documentation Support and
completes Change Requests, SOP and Test Method updates, and
associated documents
- Track / trend key performance indicators and identify adverse
events in testing and escalate as needed to prevent
reoccurrence
- Participate and/or lead continuous improvement activities to
help improve the overall operations of the testing labs
- Maintain analytical laboratory in a state of control,
compliance, and inspection readiness
- Supports sample preparation teams
- Partner with colleagues in various departments (e.g., AD/PD,
Facilities, Engineering, QA and Regulatory) to ensure achievement
of company goals
- May conduct other Quality Control related duties as assigned
Education & Experience
- Bachelor's degree in Cell Biology or Immunology or related
discipline in Biology preferred with 4+ years of experience in
Biotechnology industry
- Or Master's degree with 2+ years of industry experience
- Experience working with mammalian cells preferred Knowledge,
Skills, & Abilities
- Excellent interpersonal, communication, organizational, and
problem-solving skills
- Working knowledge of QC testing requirements, methodology, and
equipment such as Cell Culture, Cell Counters, Plate Readers, and
Flow Cytometry
- Knowledge of cGMP, FDA, and USP regulations and a basic
understanding of statistics
- Flexibility and the ability to thrive in an efficient, highly
interactive, goal-oriented team environment.
- Knowledge of MS Word and Excel Working Environment / Physical
Environment
- Ability to work full time on-site The pay range for this
position is below. The specific rate will depend on the successful
candidate's qualifications, prior experience as well as geographic
location. $38.00 (entry-level qualifications) to $48.00 (highly
experienced) ImmunityBio employees are as valuable as the people we
serve. We have built a resource of robust benefit offerings to best
support the total wellbeing of our team members and their families.
Our competitive total rewards benefits package, for eligible
employees, include: 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 15 Vacation Days, 56 Hours of Health
Pay, 2 Personal Days and and 1 Cultural Day* We are committed to
providing you with the tools and resources you need to optimize
your Health and Wellness. ImmunityBio employees are as valuable as
the people we serve. We have built a resource of robust benefit
offerings to best support the total wellbeing of our team members
and their families. Our competitive total rewards benefits package,
for eligible employees, include: 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 15 Vacation Days, 56
Hours of Health Pay, 2 Personal Days and and 1 Cultural Day* We are
committed to providing you with the tools and resources you need to
optimize your Health and Wellness. 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. ImmunityBio is
a mandatory vaccination employer for COVID-19 and its variants. The
Company requires that its employees be fully vaccinated as of their
start date. If you require a medical or religious accommodation we
will engage in the interactive process with you. Proof of
vaccination will be required prior to start. If we make you an
offer and you are not yet vaccinated, we will accommodate a delay
in start date. ImmunityBio may also mandate that its employees
receive vaccine boosters, and all accommodation laws will be
followed.
Keywords: ImmunityBio, San Diego , Specialist, Quality Control Analytical, Other , San Diego, California
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