Overview
Quality Engineer I Jobs in Fairfield, CA at Toray Advanced Composites USA,Inc
This position will be remote based in the Mid-Atlantic region or Boston area with 30-40% of time spent at a Mid-Atlantic based CDMO.
You Will…:
Direct and oversee method validation and transfer activities, including tech transfer to an external CDMO, to ensure GMP compliance.
Lead QC investigation of quality events including laboratory investigations, OOS/OOT and deviations, and support manufacturing investigations as needed.
Support development of specifications for raw material, drug substance, intermediate and final product testing, and stability testing.
Author and review test methods, protocols, reports and associated documents.
Support data trending and quality metrics.
Support regulatory submission activities.
Collaborate closely with QA, Regulatory, Supply Chain, MSAT, AD, and PD groups and external key partners.
Assist with continuous improvement of quality and compliance.
Regularly perform QC Person In Plant activities at Obsidian’s CDMO facilities, and other duties as needed.
Core Qualifications:
Bachelor’s degree in biology, chemistry, life sciences or a related field, and 12+ years of analytical experience in biologics or CGT industry with at least 6 years in GMP QC (or M.S. and 8+ years of experience with 4 GMP QC experience).
Familiarity with relevant FDA/EMA and ICH regulatory guidelines relevant to gene and cell therapy analytical development and method validation.
Expertise with analytical method transfer and phase appropriate validation/qualification.
Experience enabling and overseeing contract test laboratories for cell and/or gene therapy products and managing quality events and investigations.
Experience with late phase to commercial programs (cell therapy, gene therapy or biologics).
Experience with QC analytical methods optimization and troubleshooting for cell and gene therapy products including potency assay, immunoassays/flow cytometry, PCR, etc.
A clear sense of ownership and accountability to meet commitment and high standards promoting the same with CDMO partners.
A team mindset and highly collaborative working style – build trusting relationships, share ideas and feedback, productively challenge own and others’ assumptions to generate new ideas and facilitate better outcomes. Ability to communicate effectively with scientific/technical colleagues in a dynamic, cross-functional environment.
Proven ability to manage multiple matrixed projects and tasks to completion in a fast-paced environment, anticipating risks and obstacles and adjusting to effective contingency plans.
Self-motivation and a demonstrated ability to work with general direction to meet objectives and timelines.
Flexibility – ability to adapt to changes and priorities to fulfill our mission, including after-hours or weekend support for batch release when required to deliver product to a patient.
Systems thinking – You approach problem solving and process design with consideration of the overall system as well as its individual parts, considering interrelationships and patterns.
A track record of context-based sound judgement, including when to elevate risks and issues to leadership.
An ability to be on-site at CDMO up to 30-40% of time (for day trips, the ideal location is mid-Atlantic; for other locations travel of this amount will be required).
Title: Quality Engineer I
Company: Toray Advanced Composites USA,Inc
Location: Fairfield, CA
