Quality Control Analyst

Job Title: Scientist II, Analytical Development / Quality Control

Location: Watertown, MA

Job Summary:

The Scientist II will support analytical development and quality control activities for nucleic acid and microbiome-based platforms. This role focuses on method development, validation, and tech transfer in a cGMP environment, while driving data analysis, problem-solving, and continuous improvement.

Key Responsibilities:

• Plan and execute analytical development and tech transfer activities in a cGMP setting.
• Design and perform experiments to support assay development, validation, and stability programs.
• Develop, optimize, and qualify analytical methods, including sequencing and release assays.
• Analyze complex data, interpret results, and prepare technical reports and presentations.
• Support implementation of 21 CFR Part 211-compliant systems and processes.
• Collaborate cross-functionally with Manufacturing, Quality, and external partners.
• Monitor processes, ensure timely project delivery, and contribute to continuous improvement initiatives.
• Participate in recruiting and mentoring technical staff.

Qualifications:

• Bachelor’s degree with 6+ years of experience in assay development and validation.
• Strong knowledge of cGMP environments and analytical technologies.
• Experience with method development, tech transfer, and stability-indicating assays.
• Proven ability to design experiments, analyze data, and solve complex problems.
• Excellent communication skills and ability to manage multiple priorities in a fast-paced environment.