Biomanufacturing Associate - Meridian Bioscience

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

The Lab Production Associate position is responsible for performing assigned manufacturing and laboratory support activities according to company policies, SOPs, and quality regulations. The position will be responsible for performing upstream and downstream bioprocessing procedures to support the commercial manufacturing of native antigens, recombinant proteins, antibodies, and blockers. Upstream processes include tissue culture, cell bioreactors, fermentation, virus propagation, cell and virus bank production, and buffer/media preparation. Downstream unit operations include harvest, clarification, chromatography, centrifugation, TFF (UF/DF), filtration, formulation, and fill-finish. The candidate will be required to maintain an assigned lab area and perform equipment and lab cleaning procedures. The candidate must be able to execute assigned procedures in a fast-paced and results-oriented environment satisfying quality standards in accordance with customer satisfaction, cost, schedule, and ISO1345 regulations.

Key Duties

Tasks/Duties/Responsibilities:• Coordinate daily production tasks with supervisor or manager ensuring alignment with production schedule. Independently complete daily assigned tasks following appropriate manufacturing documents, SOPs, and regulations. • Retrieve controlled documents from document control software, review procedures, ensure proper training, and ensure sufficient inventory of equipment, reagents, and materials prior to starting manufacturing activities.• Monitor and requisition or initiate in-house production of raw materials and supplies required to meet production schedules.• Assure the proper use, cleaning, sanitization, maintenance, validation, calibration and certification of required equipment as appropriate.• Understand and apply the concepts of aseptic technique.• Generate and record all data and observations as required and complete all necessary calculations in compliance with company policies. • Immediately notify supervisor or manager of any deviation from written production document or SOP.• Maintain accurate data sheets, records, and logs in compliance with SOPs, OSHA requirements, and quality system requirements. • Audit own paperwork daily for corrections, missing, and/or incomplete information. • Perform routine laboratory maintenance and lab management including ordering of materials, cleaning and maintenance of laboratory equipment, cleaning lab area, environmental monitoring, and filling out proper paperwork.• Assist, as required, in investigations for all product or process nonconformances including deviations, OOS, CAPA, or complaints. • Assist in procedure reviews and document correction/improvement processes. • Troubleshoot and mitigate any observed issues with resources, schedule, procedure, or product quality collaborating with appropriate departments, supervisors, or manager to adhere to company goals. • Independently complete all training as assigned and read/respond to daily company correspondences as required.

Other duties as assigned.

• Primary work requirements include working in a regulated bioprocessing setting.
• Ability to walk up and down several flights of stairs throughout the workday in a multi-location facility.
• Must be able to routinely lift to 40 lbs. during the work shift.
• Must be able to wear personal protective equipment (face coverings, gloves, lab coats, etc.)
• Ability to stand and sit for long periods of time, stoop, reach, push and pull carts throughout the course of the work shift.
• Ability to concentrate, analyze, and solve complex issues throughout the day.
• May be required to work outside of normal business hours including evenings and/or weekends to support business needs.
• Must be able to adhere to applicable biosafety and chemical hygiene practices when on the manufacturing floor or in laboratories.

Qualifications

• Bachelor’s from an accredited institution with a relevant scientific discipline such as Chemistry, Biology, Biochemistry, Molecular Biology, Protein Chemistry etc. is preferred.• Associates degree or High school diploma/GED and 3+ years of bioprocessing experience in a GMP facility is minimal requirement.

• Previous manufacturing or assembly experience in a quality regulated environment is desirable. • Previous experience operating bioreactors, fermenters, FPLC systems, and TFF systems desirable.

• Key Stakeholderso This position will collaborate with manufacturing, quality, materials management, technical operations, and other departments as required to complete assigned tasks. The position will report progress to necessary departments and individuals.o This position will interact with internal contacts. The position will complete daily assigned manufacturing activities and other projects as assigned.

• Line Managemento This position reports to the Manufacturing Managers or Supervisors. o This position is an independent contributor. o The position will have no direct reports.

*We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing. (USA Only)*