Upstream Manufacturing Associate Scientist - Cell culture

Cell Marque Corporation•St. Louis, MO

48d•$23 - $42•Onsite

About The Position

The Upstream Manufacturing Associate Scientist performs laboratory operations required to manufacture and monitor antibody production including cell culture, bioreactors, transient transfection, ELISA, and tissue staining according to established manufacturing procedures with some supervision; completes required tasks per standard operating procedures involving laboratory techniques, calculations, material measurements, operation of laboratory equipment, and record keeping as necessary.

Requirements

Associates Degree in any Life Science discipline.
2+ years of cell culture experience.
Meet vision standards as outlined by occupational guidelines.
Lift and move up to 25 lbs and occasionally push up to 25 lbs unassisted.
Frequently required to sit or stand, depending on the process needs.
Occasionally required to climb ladders/step ladders, kneel, stoop, or perform tasks involving full body use.
Capable of performing repetitive motions with hands, including fine manipulation such as pipetting or typing.
Reach with hands and arms, and occasionally lift or stand for extended periods.
Perform tasks requiring simultaneous use of multiple physical abilities, as needed by the process.

Nice To Haves

Experience following Standard Operating Procedures, accurate completion of Manufacturing.
Procedure batch records, and adherence to Quality and Regulatory.
Bachelor's Degree in any Life Science discipline.
Previous experience in FDA regulated biotechnology or pharmaceutical environment.
Knowledge of FDA QSRs and ISO 13485 or other related industry standards.
Experience with SAP or other ERP system.
Excellent computer skills, including MS 365 as well as organizational skills and attention to detail.
Excellent time management and project management skills.
Knowledge of SAP NEXT.

Responsibilities

Perform laboratory operations required to manufacture and monitor antibody production including cell culture, bioreactors, transient transfection, ELISA, and tissue staining according to established manufacturing procedures.
Ensure compliance with cGMP, FDA, ISO, and other applicable regulatory standards (OSHA, USDA, EPA), meeting all quality requirements and deadlines.
Support the development, documentation, and continuous improvement of lab procedures and manufacturing processes to maintain regulatory compliance.
Assist in the development and validation of new assays, instrumentation, and manufacturing workflows; support staff training as needed.
Maintain accurate records using local ERP systems and ensure proper documentation of all manufacturing processes.
Perform routine equipment maintenance, manage inventory of chemicals and supplies, and contribute to general lab cleanliness.
Escalate non-conformances, participate in investigations, and proactively seek opportunities to improve productivity, quality, and compliance.
Follow site-specific regulatory and quality standards (e.g., MDSAP, ISO 13485, IVDR) and perform other duties as assigned to support business needs.