**Manufacturing Supervisor** Manufacturing Chicago, IL, US + Added - 17/01/2025 Apply for Job **_This is an exciting opportunity for an experienced biopharma manufacturing professional to continue their career in downstream/upstream manufacturing. This role will be with our client who has a global footprint in both R&D and manufacturing within the biopharma industry._** **Hours** **:** **3** **rd shift** **10:00pm – 6:30am** **Salary** : $80,000 - $105,000 depending on experience (direct hire) **Essential Duties & Responsibilities** + **Execute and Delegate:** Execute and effectively delegate work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities. Ensure quality data is maintained while meeting production goals, timelines, and minimizing downtime/delays. Perform work instructions with minimal supervision, including but not limited to: + Weighing and dispensing materials. + Media and buffer preparation. + Operating filtration systems (e.g., dead-end filtration, depth filtration, tangential flow filtration). + Inoculating, fermenting, harvesting, and homogenizing cytokine cells. + Setting up and operating chromatography columns. + Performing aseptic final filtration of intermediates and drug substances. + **Quality Monitoring:** Monitor product quality using PLC controls, HMI interfacing, integrity testing, and in-process testing (e.g., pH, conductivity, spectroscopy). Routinely adjust controls and interact with HMI interfaces to ensure smooth equipment operation. Diagnose and troubleshoot equipment and manufacturing processes. + **Multitasking and Problem-Solving:** Possess the ability to multitask, solve problems, and formulate action plans based on real data and experience. Thrive in a fast-paced, team-oriented environment. + **Training and Development:** Train diverse team members, ensuring employee training is current and meets job standards. + **Team Engagement:** Build team engagement through regular 1:1 meetings, goal-setting, performance reviews, and providing growth opportunities. Offer coaching, counseling, development, discipline, and recognition. Manage timecards and attendance. + **Safety Prioritization:** Foster a safety-first environment by enforcing proper PPE usage, ensuring hazardous materials (e.g., buffers, chemicals) are handled and disposed of according to EHS guidelines, and maintaining clean manufacturing areas + **Cleanroom Maintenance:** Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain required conditions for cleanroom manufacturing. Perform routine area checks and coordinate with relevant personnel for resolution. + **Inventory Management:** Verify raw materials and commodities. Accurately enter inventory data into MES daily, perform routine inventory counts and adjustments, and request raw materials and commodities as needed. + **Documentation:** Complete Batch Records and other cGMP documentation accurately and promptly. Perform daily documentation reviews and approvals. Assist with Change Control, CAPA, and Deviation/Investigation documentation. + **Incident Reporting:** Report nonconformances or events to the manager and gather requested evidence during the shift. + **Technology Transfer:** Assist in transferring technology from Process Development to cGMP Manufacturing. Participate in qualification and validation activities. + **Document Authoring:** Author and review SOPs and other documents to integrate cGMPs and improve process efficiency. + **Process Monitoring:** Perform process monitoring using databases, documents, and spreadsheets to meet business reporting requirements. + **Continuous Improvement:** Propose improvements and efficiencies to reduce waste and increase production while adhering to quality standards. + **Policy Compliance:** Comply with all safety, cGMP, and company policies, practices, and procedures **Position Requirements and Qualifications** **Education:** + Bachelor’s degree in engineering, pharmaceuticals, or related life sciences with at least five years of experience; or + Master’s degree in engineering, pharmaceuticals, or related life sciences with at least two years of experience; or + An equivalent of 5–10 years of industry experience is required. + Upstream and downstream manufacturing or biotechnology experience is preferred. Supervisory experience is also preferred. **Special Skills:** **Technical Proficiency:** + Proficiency with systems such as Delta, PCR, POMS, LIMS, SAP, etc. + Knowledge of GMP, safety requirements, and the current Code of Federal Regulations (CFRs). + Familiarity with lean and continuous improvement tools (e.g., 5 Why, RCFA, Six Sigma). + Experience with biotechnology operations such as aseptic filtration systems, filter integrity testing, fermentation, chromatography columns, mixing systems, and weighing scales INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.