Agency Temporary - Specialist, QC Analytical

NantWorks (the "Company") is the parentcompany of various private and public entities that are changinghow we work, live and play. We focus on three main categories: lifesciences; energy & renewables; and media & technology. We investin strategies that improve our core capabilities and in brandnew industries, poised to change mankind for the better. Bycapturing tomorrow's opportunities through scientific processes andentrepreneurial philosophies, we are at the forefront of emerginghigh-growth technologies across a wide range of industries.

The Company 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. The Company may also mandate that its employees receive vaccine boosters, and all accommodation laws will be followed.

Position Summary

The Agency Temporary - Specialist, QC Analytical will serve as Subject Matter to advise contract testing laboratories on method development, method validation, method transfer, and quality investigations. Primary duties will include data review and troubleshooting of analytical test methods.

Essential Functions

• Author, review and revise documentation (SOPs, test methods, analytical method development, method validation, method transfer protocols/ reports, product specifications)
• Review QC stability and lot release data (data integrity check) and CoAs issued by contract testing laboratories and create batch release certificate of analysis
• Author and review laboratory OOS investigation and invalid laboratory test result, including filing internal Quality Systems reports as applicable
• Author, review and revise Analytical Section of documents such as the IND, BLA for regulatory CMC submission
• Provide technical expertise to troubleshoot analytical methods
• Mange suppliers change notifications and change controls
• Generate Purchase Requests and Purchase Orders for contract testing laboratories projects
• Ensure timely escalation of quality control related issues
• Assist QC-Analytical management in tracking and trending data
• Collaborate with other departments (e.g. QA and Regulatory) for quality control related duties
• Attend QC-Analytical internal meetings and external meetings with contract testing laboratories
• May conduct other duties, as assigned

Education & Experience

• Bachelor's degree with 8+ years relevant experience in Analytical Chemistry or related discipline required; or
• Master's degree with 6+ years of experience in Analytical Chemistry or related discipline required.
• Experience in method development, method validation, method transfer, lot release tests, stability programs and specification development required

Knowledge, Skills, & Abilities

• Strong knowledge of quality control analytical method development, method validation and method transfer
• Strong technical writing skills to author SOPs, analytical tests methods, qualification/validation protocols/ reports
• Knowledge and understanding of USP, EP and ICH guidelines
• In-depth knowledge of GMPs and pharmaceutical regulations
• Ability to communicate effectively with internal functions both in writing and verbally
• Ability to collaborate with contract testing laboratories, consultants, ensuring compliance with company procedures
• Ability to multi-task and prioritize
• Strong problem solving
• Strong computer skills

Working Environment / Physical Environment

• This position will work on hybrid (combination on site and remote) in El Segundo, CA
• Regular work schedule is Monday - Friday, within standard business hours. Flexibility is available with manager approval.

This position is eligible for a discretionary bonus and equity award. The annual base 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.

$44.69 (entry-level qualifications) to $49.65 (highly experienced) per hour

The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.