QC Bioanalytical Scientist - Molecular & Cell Assays (ddPCR / HPLC)

Advance your life sciences career with a premier biopharmaceutical leader in Plainville, MA. Join our Quality Control Bioanalytical laboratory team on a first-shift schedule (Mon-Fri, 8:00 AM - 4:30 PM).

About the role

Perform cGMP bioanalytical testing, method transfers, and equipment maintenance to directly support clinical and commercial manufacturing operations.

Responsibilities

• Perform Right-First-Time (RFT) cGMP bioanalytical testing for in-process, release, stability, and utility samples following approved SOPs.
• Execute and troubleshoot assays including TOC/Conductivity, pH, osmolality, ddPCR/qPCR, ELISA, UHPLC, and CE-SDS.
• Support method transfers, qualifications, validations, and technical verifications for clients.
• Author and revise SOPs, work instructions, and quality records (e.g., LIRs, Deviations, OOS, and CAPAs) in TrackWise and LIMS.
• Perform equipment calibration, data review, reagent preparation, and laboratory organization to maintain audit readiness.

Requirements

• Bachelor's degree in Biological Sciences, Analytical Chemistry, Molecular Biology, or a related field.
• 1-3+ years of relevant industry experience as a laboratory analyst/scientist in a GxP-regulated setting.
• Hands-on experience with bioanalytical testing, equipment troubleshooting, and cGMP quality systems.
• Ability to work semi-independently, manage multiple priorities, and lift up to 30 lbs.

Preferred Qualifications

• Direct experience with method transfers, technical writing, and software platforms such as Empower, SampleManager LIMS, and TrackWise.

Skills

• Molecular Biology
• Laboratory Information Management Systems (LIMS)
• Good Manufacturing Practices (GMP)
• Corrective and Preventive Actions (CAPA)
• Good Documentation Practices (GDP)

Pay

$28 - 32 per hour

Schedule

First shift: Monday - Friday, 8:00 AM - 4:30 PM

Benefits

• Medical, prescription, dental, and vision insurance
• AD&D and life insurance
• Short-term disability
• 401K plan