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Description

The candidate will help the performance of operations in support of the manufacture of Commercial and Clinical Biologics. They will follow Current Good Manufacturing Practices (cGMPs) and carrying out a variety of functions related to Upstream (cell culture) and Downstam (chromatography). In this role, you will have the opportunity to work with a team of exceptional professionals and play a vital role in the flawless execution of manufacturing batch records, work instructions, and SOPs. Your keen attention to detail and proactive approach will ensure that all tasks are completed right the first time. Additionally, you will assist in maintaining the suite, supplies, equipment, logbooks, and data to strict cGMP standards, contributing to the success of our manufacturing operations. Execution of manufacturing batch records, work instructions and/or SOPs, with focus on proactive ‘right the first time’ executions. Assist with batch record reconciliation. Assist in all Department functions, such as maintaining suite, supplies, equipment, logbooks and data in accordance with site SOPs and policies. Documentation of all activities to meet cGMP requirements. Complete document reviews and revisions. Daily record review, tasks, and databases. Actively provide feedback. Participate/Lead in shift exchanges, 1-1’s, meetings, attend meetings as needed to facilitate area needs based on changes, etc. (lean activities). Support a quality investigation by answering questions, providing feedback and making suggestions for improvement. Practices and promotes safe work habits and adheres to safety procedures and guidelines. Critical evaluation of processes, including foresight and thinking ahead. Ensure tasks are performed with a method of prioritization - interpret production schedules and complete tasks accordingly. Manufactures buffers and simple bulk reagents per manufacturing procedures with limited supervision and will be involved with Upstream and Downstream process. Participates in process improvement projects. Key Responsibilities: • Responsible for reviewing all area documents. • Responsible for the WNS. • Assist in manufacture of controls and calibrators and complete batch records following cGMPs. • Perform in-process assays using equipment such as spectrophotometers, pH meters and clinical analyzers. • Weighing, transfer, mixing of chemicals required. • Perform product filtrations. • Clean and steam steel tanks (CIP) / (SIP). • Prepare glassware and steel tanks for sterilization in autoclave and operate autoclave. • Maintain lab equipment including pumps, pH meters, and flow meters. • Keep department lead or manager updated on all issues. • Monitor stocks of common lab supplies. • Performs other job duties as required. • Responds to Emergency notifications. • Flexible hours and on weekends.

Skills

Gmp, Cleanroom, aseptic technique, Cgmp, Aseptic, Biology, Laboratory, cell culture, chemistry, chromatography, Pharmaceutical, Pharmaceutical industry, cell culturing, bioreactor

Top Skills Details

Gmp,Cleanroom,aseptic technique,Cgmp,Aseptic,Biology,Laboratory,cell culture,chemistry,chromatography

Additional Skills & Qualifications

Education: • HS Diploma or equivalent required, BS Degree in STEM related field preferred Experience: • Required: Minimum of 2 years of work experience in manufacturing, operation, production, lab setting or related field • Preferred: Experience in a cGMP environment Knowledge • Knowledge of cGMP practices, aseptic techniques, or chemical concepts- preferred • Subject Matter Expert on upstream processing steps- preferred

Experience Level

Expert Level

Pay and Benefits

The pay range for this position is $27.00 - $31.05/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 Type

This is a fully onsite position in Saint Louis,MO.

Application Deadline

This position is anticipated to close on Jun 2, 2025.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.