Senior Manager, Quality Control Analytical

About the role

The Senior Manager, Quality Control Analytical will manage laboratory testing activities for various programs, oversee preventive maintenance, and perform administrative duties. Key responsibilities include overseeing analytical testing, managing lab staff, coordinating with other departments, reviewing assay protocols, and ensuring compliance with regulatory guidelines.

Responsibilities

• Oversight and scheduling of analytical testing for In Process testing, suitability for use testing, method development, qualification, optimizations, transfer and investigational studies.
• Interface as QCA member to interact with other departments to coordinate activities.
• Review of assay protocols and reports in line with commercial GMP standards.
• Backup analyst for completing assays.
• Participate and coordinate method development, optimization, transfer, and qualification work (protocol drafting, data collection, and report writing).
• SOP and Test Method drafting and revisions.
• Ensure quality control staff, equipment, and procedures are compliant to regulatory guidelines and data integrity principles are adhered to.

Requirements

• Bachelor’s degree in Cell Biology or Immunology or related discipline with 8+ years’ of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required; OR Master’s degree in Biology or related discipline with 6+ years of relevant experience in the biotechnology industry with emphasis in analytical development or quality control testing required.
• Experience with QC testing requirements, methodology and equipment such as HPLC and Plate Readers required.
• Experience leading a team in a GMP environment strongly preferred.

Qualifications

• Demonstrated understanding of QC testing requirements, methodology and equipment such as HPLC and Plate Readers.
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics.
• Knowledge of MS Word, PowerPoint, and Excel.
• Ability to work independently and within cross-functional teams to deliver on project timelines and department goals.

Skills

• Demonstrated understanding of QC testing requirements, methodology and equipment such as HPLC and Plate Readers.
• Knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics.
• Knowledge of MS Word, PowerPoint, and Excel.
• Ability to work independently and within cross-functional teams to deliver on project timelines and department goals.

Benefits

ImmunityBio offers a comprehensive benefits package including medical, dental, and vision plans, health and financial wellness programs, an employer assistance program, life and AD&D insurance, short-term and long-term disability coverage, flexible spending accounts, a 401(k) retirement plan with company match, a 529 education savings program, voluntary legal services, identity theft protection, pet insurance, and employee discounts, rewards, and perks. Additionally, there is unlimited PTO for exempt employees and 10 vacation days, 56 hours of health pay, 2 personal days, and 1 cultural day for non-exempt employees.

Pay

$145,000 (entry-level qualifications) to $159,500 (highly experienced) annually

Schedule

This position works on-site in Dunkirk, NY. This position works in a lab environment and requires flexibility in working schedule, including off-hours. Must be able to gown and gain entry to labs. Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer. Lift and carry materials weighing up to 20 pounds.