Job Description
The candidate will support the operations involved in manufacturing Commercial and Clinical Biologics. You will adhere to Current Good Manufacturing Practices (cGMPs) and perform various functions related to Upstream (cell culture) and Downstream (chromatography) processes. This role offers the opportunity to collaborate with a team of exceptional professionals, playing a crucial role in executing manufacturing batch records, work instructions, and SOPs flawlessly. Your attention to detail and proactive approach will ensure the completion of tasks right the first time. Additionally, you will assist in maintaining the suite, supplies, equipment, logbooks, and data according to strict cGMP standards, contributing significantly to the success of our manufacturing operations.
PAY - $28-$32/hour
Responsibilities
Execute manufacturing batch records, work instructions, and SOPs with a focus on proactive 'right the first time' executions.Assist with batch record reconciliation and all department functions, including maintaining suite, supplies, equipment, logbooks, and data in accordance with site SOPs and policies.Document all activities to meet cGMP requirements, complete document reviews and revisions, and actively provide feedback.Participate and lead shift exchanges, meetings, and attend meetings as needed to facilitate area needs.Support quality investigations by answering questions, providing feedback, and suggesting improvements.Practice and promote safe work habits, adhering to safety procedures and guidelines.Critically evaluate processes, including foresight and prioritization of tasks based on production schedules.Manufacture buffers and simple bulk reagents per manufacturing procedures, participate in process improvement projects.Review all area documents and assist in manufacturing controls and calibrators.Perform in-process assays using equipment such as spectrophotometers, pH meters, and clinical analyzers.Weigh, transfer, and mix chemicals, perform product filtrations.Clean and steam steel tanks, prepare glassware and steel tanks for sterilization, and operate autoclave.Maintain lab equipment including pumps, pH meters, and flow meters.Monitor stocks of common lab supplies and respond to emergency notifications.Be flexible to work hours including weekends.Essential Skills
Knowledge of cleanroom and aseptic techniques.Understanding of biology, laboratory practices, cell culture, chemistry, and chromatography.Minimum of 6 months experience in a GMP regulated environment preferred.Bachelor's Degree in Science with knowledge of aseptic techniques, cell culturing, pipetting, chromatography, biochemistry.Minimum of 2 years work experience in manufacturing, operation, production, lab setting, or related field required.Additional Skills & Qualifications
HS Diploma or equivalent required, BS Degree in STEM related field preferred.Knowledge of cGMP practices, aseptic techniques, and chemical concepts preferred.Subject Matter Expert on upstream processing steps preferred.Work Environment
Work in cleanroom and aseptic suites, requiring willingness to gown up and adhere to strict cleanroom gowning requirements. Day Shift operates from 6:45am-6:45pm and Night Shift from 6:45pm-6:45am, with rotating 12-hour shifts. The schedule involves working 7 days out of a 2-week period. Be prepared to wear a full gowning suit including bodysuit, gloves, hair & beard nets, face covers, and safety glasses. The role requires the ability to lift a minimum of 25 lbs independently and stand for 80% of the shift.
Job Type & LocationThis is a Contract to Hire position based out of Saint Louis, MO.
Pay and BenefitsThe pay range for this position is $28.00 - $32.20/hr.
Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace TypeThis is a fully onsite position in Saint Louis,MO.
Application DeadlineThis position is anticipated to close on Feb 19, 2026.
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