3rd shift Manufacturing Supervisor (Biotech)
3rd shift Manufacturing Supervisor (Biotech)
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This range is provided by Astrix. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$93,000.00/yr - $104,000.00/yr
Direct message the job poster from Astrix
Scientific and technical staffing leader connecting top talent with industry-leading companies
Hours: 3rd shift10:00pm – 6:30am
Essential Job Functions:
- 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
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:
Language:
- Basic verbal and written communication skills in English.
- Ability to understand technical information, procedures, batch records, and other documents in English.
- Excellent interpersonal skills for effective communication with peers, supervisors, and supporting departments.
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
Seniority level
Seniority level
Mid-Senior level
Employment type
Job function
Job function
Manufacturing and ScienceIndustries
Pharmaceutical Manufacturing and Biotechnology Research
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Inferred from the description for this job
Medical insurance
Vision insurance
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