Manufacturing Associate I

About the company

LGC Clinical Diagnostics develops and manufactures a comprehensive portfolio of catalogue and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, pharmaceutical, CRO, and academic institutions in commercialization activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.

Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, a manufacturer and supplier of viral antigens, and LGC Proficiency Testing, a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), an ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan, US.

About the role

The Manufacturing Associate I applies direct labor for manufacturing high-quality diagnostic products using manual and semi-automated equipment. This role is responsible for setting up, calibrating, and operating all manufacturing equipment in line with cGMP, POPs, SOPs, Safety, and departmental policies. You will use good judgment and critical thinking skills to make operator-level decisions regarding product quality.

Responsibilities

• Prepare products according to approved Manufacturing Process Operating Procedures (POPs), Standard Operating Procedures (SOPs), cGMP, and ISO 13485 quality systems.
• Perform all assigned manufacturing processes while adhering strictly to departmental safety policies to ensure minimal error.
• Maintain work area in a clean and orderly fashion, promoting a positive teamwork environment and continuously sharing improvement ideas.
• Support other departments as needed to facilitate cross-training and assist the business unit.
• Occasionally lift and move materials weighing up to 50 lbs using appropriate equipment.
• Perform other tasks as directed by the manager.

Work environment

The role operates in biological and chemical manufacturing environments, including cleanrooms. Weekend and off-hour work may be required to accommodate the operations schedule.

This position follows a rotating schedule: Monday through Thursday one week, then Tuesday through Friday the following week, with working hours of 4:00 a.m. to 2:30 p.m. ET.

Requirements

• High School Diploma or equivalent work experience.
• Basic mathematical skills.
• Ability to be on feet for 6-10 hours per day.
• Analytical and critical thinking skills.

Preferred qualifications

• 1 to 3 years in a Life Science, cGMP/ISO environment, including clean rooms in a manufacturing department role.
• Bachelor’s degree or equivalent experience, with a concentration in Biology, Chemistry, or related science.
• Experience with Microsoft Office (Word, Excel, Office).
• Experience with automated filling machines.

Pay

The salary range for this position is $20 to $28 USD per hour. The base salary will be influenced by factors like experience, skills, and location.