Senior Scientist, Quality Control Analytical

ImmunityBio, Inc.•Dunkirk, NY

22h•$125,000 - $137,500•Onsite

About The Position

The Senior Scientist, Quality Control Analytical provides analytical testing leadership for various programs such as fusion proteins, cell therapies and cancer vaccines. The analytical testing will include but is not limited to the wet chemistry, chromatography (HPLC, Capillary Electrophoresis), spectroscopy (UV-Vis), and ELISA. The position will also take on a lead role for providing testing support through In Process testing, and suitability for use testing, method development, optimizations, transfer, qualification work and investigational studies. The Senior Scientist will undertake complex troubleshooting and investigations.

Requirements

Master’s degree in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 7 years of experience in the biotechnology industry required; or Ph.D. in Analytical Science (chemistry, biochemistry, or other scientific related field) with at least 3 years of experience in the biotechnology industry required.
Extensive experience with assay development, qualification, validation, and transfer activities.
Experience working in cGMP laboratory required
Hands-on experience with HPLC and ELISA required
Working knowledge of QC testing requirements, methodology, and general equipment such as pH meter and analytical balance
Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
With safety as the priority excellent laboratory techniques
Proficiency in the use of multiple HPLC instrument platforms (e.g. Thermo, Agilent, etc.)
Strong technical problem-solving ability both independently and as part of a team.
Motivated to work independently to produce high quality work in an efficient manner.
Strong computer skills, including Microsoft Office
High attention to detail in all aspects of the work
Strong organizational skills, attention to detail, and ability to prioritize and manage multiple projects simultaneously.
Excellent communication skills, with the ability to effectively interact with cross-functional teams, senior management, and external entities.
In-depth knowledge in analytical method development and validation, and statistical quality control.
Ability to use sound scientific judgment in management of the facility and processes to prevent regulatory action.
Deep understanding of GMPs, SOPs, and pharmaceutical regulations, and an ability to interpret and enforce regulatory requirements.
Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to analyze and interpret complex, scientific documents, including problem solving.

Nice To Haves

Hands-on experience with biological assays (e.g. cell cultures) preferred

Responsibilities

Develop strategies, and support the introduction, validation and on-going technical agenda for pipeline and commercial analytical chemistry methods and technology.
The polishing of analytical methods to implement GMP-friendly structure into the method.
Drafting and reviewing of protocols, reports, and methods to support the method validation lifecycle.
Complex troubleshooting of methods
Development of new assays to support raw material, in process, drug substance, or drug product release and stability testing.
As required, provide training or mentorship to other QC or cross functional team members.
Act as Subject Matter Expert (SME) for analytical chemistry within QC. This may include the identification, purification and separation of the components in an unknown mixture.
Complete structural analytical characterization (via experimental analysis or review of outsource reports) on various drug products, including product related impurities.
In the event of non-conformance to acceptable quality and/or safety standards (including invalid assays), lead analytical investigations, using Root Cause Analysis techniques where appropriate.
Work with the QC team to improve the state of validation and drive analytical variability reduction.
Draft and edit documents, Standard Operating Procedures (SOPs) and test plans as needed.
Lead continuous improvement activities to help improve the overall operations of the testing labs.
Track / trend key performance indicators and identify adverse events in testing and escalate as needed to prevent reoccurrence.
Partner with colleagues in various departments (e.g., AD/PD, Facilities, Engineering, QA and Regulatory) to ensure achievement of company goals.
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