CMC Quality Control Scientist

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.

• 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.

Qualifications :

Minimum Required Qualifications:

• 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.

Preferred Qualifications:

• 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.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Additional Information :

Position is Full Time Monday-Friday 8am-5 pm. Candidates currently living within a commutable distance of Boston MA are encouraged to apply

Excellent full-time benefits include:

• Comprehensive medical coverage dental and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holiday
• Yearly goal-based bonus & eligibility for merit-based increases
• Compensation: $37.00-$41.00 per hour

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.

Remote Work :

No

Employment Type :

Full-time