Mercy BioAnalytics, Inc., is a biotechnology company dedicated to reducing suffering and saving lives through the early detection of cancer. Backed by extensive clinical validation, we are advancing one of the most important innovations in modern medicine: detecting cancer at its earliest, most treatable stages through a simple blood draw.
We are looking for a passionate individual to join our Manufacturing team, whose mission is to bring our products into commercial readiness.
This mission critical role is essential to maintaining a GMP compliant, efficient, and safe manufacturing environment that enables cutting-edge diagnostic production and release. The ideal candidate will have experience in cGMP workflows, inventory control, and support of regulatory readiness (e.g., ISO 13485, CLIA, FDA).
Candidates for this position must enjoy working for a fast-paced, innovative company, be able to work in a highly collaborative and teamwork-oriented environment and exhibit a passion for being a part of our life-saving mission.
Responsibilities:
Execute day-to-day manufacturing operations including label printing, labelling, formulations and dispensing in accordance with cGMP requirements and standards
Prepare, set up, clean and maintain cGMP spaces and equipment and materials before and after manufacturing operations
Perform routine and critical manufacturing activities in accordance with work instructions and SOPs while maintaining strict adherence to quality and documentation requirements
Maintain a clean, organized, and inspection ready manufacturing environment in compliance with cGMP, ISO 13485, FDA QSR and applicable regulatory requirements
Support controlled material management activities including material issuance, reconciliation, inventory counts, and inventory accuracy
Identify, document and communicate production non-conformances, deviations, and quality events in accordance with quality system requirements
Complete batch records, logs, and other documentation in a timely and accurate manner
Collaborate closely with Quality, Development, Supply Chain and Operations teams to support Manufacturing objectives and product efforts
Participate in equipment qualification, process validation, and continuous improvement initiatives to improve manufacturing efficiency, scalability and robustness
Follow all safety protocols and maintain a safe working environment including appropriate use of personal protective equipment (PPE) and handling of biological materials
Support controlled material management activities, including issuance of materials and physical inventory counts
Requirements:
Associate or Bachelor’s degree in biological, chemical or physical science, or equivalent experience
Minimum 2 years of experience in a cGMP production environment with degree, ideally within an ISO regulated setting
Strong organizational and multitasking skills with attention to detail
Comfortable working in a dynamic environment where priorities can shift quickly
Excellent communicator with a proactive, can-do attitude and ability to work cross-functionally
Strong time management skills to efficiently complete manufacturing tasks and move on to the next
Strong familiarity with general laboratory equipment and consumables (pipettes, scales, etc.)
Working knowledge of regulatory standards such as ISO 13485, CLIA, cGMP, QSR is highly desirable
The ability to occasionally lift and move equipment, materials, and supplies weighing up to 50 lbs., stand/walk for extended periods
Lean manufacturing experience, a plus
Comfortable wearing PPE and operating in the presence of low-level biohazards
Proficiency in Microsoft Office
Hiring Manager: Senior Manager, Manufacturing
Location: In Person (Waltham, MA Office)
Status: Full Time
Job ID: MNF003
Base Salary Range: $72,500 – $82,000