CMC Quality Control Scientist

Eurofins USA PSS Insourcing Solutions•Boston, MA

2d•$37 - $41•Onsite

About The Position

We are seeking a highly skilled, passionate, and motivated scientist to join our CMC Quality Control team to support day-to-day analytical testing. This role will support testing by preparing formulation media and buffers, maintaining cells, stocking the lab, and performing analytical procedures. The position will be part of a technical operations team that aims to advance preclinical gene editing candidates into the clinic and works closely with Quality Assurance, Operations, and internal/external quality control groups.

Requirements

B.S. in Chemistry, Biology, or related field with 3-4 years of relevant experience.
Proficiency in mammalian cell culture.
Proficiency in cell-based functional assays and PCR.
Proficiency with electronic lab notebooks.
Ability to perform routine testing, follow SOPs, keep accurate records, and comply with company policies.
Thorough attention to detail with the ability to critically analyze ideas, data, and reports.
Proactive mindset and willingness to take initiative to drive tasks to completion.
Strong time management and multitasking skills.
Ability to work independently and collaborate in a dynamic, cross-functional environment.
Effective communication and documentation skills.
Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

Familiary with NGS.
Demonstrated experience in Good Documentation Practices in a cGMP-regulated environment.
Experience with LIMS and other data management systems.
Experience authoring, reviewing, and approving documents in electronic document management systems.
Knowledge and understanding of ICH guidelines, FDA/EMA regulations, and cGMP documentation practices.

Responsibilities

Prepare buffers and media to support testing.
Maintain cells, perform cell culture, and manage cell testing.
Identify key consumables and supplies within QC Lab and maintain stock as needed.
Log incoming samples.
Ship samples, controls, and reference standards to third party organizations.
Perform analytical testing of release and stability samples.
Maintain lab housekeeping program.
Other duties as assigned.