Bioassay Associate

Job Summary

The QC Bioassay Associate will support in-process and release testing for raw materials, drug substance and mRNA drug products produced at the company’s manufacturing facilities and affiliated contract organizations. Additionally, this position will assist management in ensuring the goals and milestones are met for the QC Bioassay Lab as well as day-to‑day operations.

Location: Norwood, Massachusetts
Job Type: Contract
Salary: $30 - $37 per hour
Work Hours: 9 to 5
Education: Bachelor's

• Utilize knowledge and investigative skills to identify and resolve issues and drive continuous improvement initiatives in laboratory operations
• Support testing of raw materials, drug substance and drug product, including generation of testing data in support of commercially approved products and clinical studies
• Assist in development, implementation, and maintenance of general laboratory operational systems in accordance with cGMP requirements
• Collaborate with development groups for method transfers and qualifications in support of expanding the QC Bioassay laboratory capabilities, including sequencing and qPCR assays as required
• Conduct technical assessments of deviations and investigations ensuring day‑to‑day operations are successful
• Perform on‑the‑job (OJT) training and act as mentor to QC Bioassay staff
• Assist in equipment qualification/validation activities, including maintenance
• Assist with scheduling and resource allocation including Tier meetings as needed
• Represent the QC Bioassay team in the absence of management
• Work directly with management to ensure QC goals and milestones are met
• Lead and organize continuous improvement projects
• Troubleshoot issues related to equipment, laboratory procedures and assay performance
• Write/revise SOPs, technical protocols, and reports
• Assist with audit preparation and regulatory compliance
• Respond to and address CTU alarms
• Foster a positive and inclusive work culture that promotes collaboration, innovation, and continuous improvement
• Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements
• Execute tasks precisely as defined in internal guiding documents, including but not limited to SOPs and work instructions
• Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections
• Complete training and assigned required learning plans accordingly to the defined due dates and prescribed requalification cadence

• BS in a relevant scientific discipline (e.g., Biochemistry)
• 2–4 years of experience
• Demonstrated aptitude or ability to learn and gain a strong understanding of GxP regulations (e.g., GMP, GLP, GCP, GVP or other applicable standards and guidances)

• Quality control
• GMP (Good Manufacturing Practice)
• SOP development

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.