Plant Manager – Director of Operations
bluestem-biosciences
Job description
About the role
We are seeking a dynamic and strategic Plant Manager to lead our biochemical production facility from commissioning through full‑scale commercial operation. You will build and mentor the operations team, drive continuous improvement, and serve as a strategic bridge to executive leadership.
Key responsibilities
- Build, structure, and mentor plant operations, engineering, and technician teams, fostering a culture of technical excellence, accountability, and safety.
- Synthesize complex site performance data and present executive‑level briefings with strategic recommendations.
- Identify operational bottlenecks, implement lean/continuous improvement strategies, and maximize plant yield and efficiency.
- Partner with R&D to establish formal technology transfer protocols and translate pilot‑scale processes into scalable plant operations.
- Oversee site master scheduling, balancing commercial production throughput with R&D/scale‑up activities.
- Maintain critical inventories, manage supply chain reordering, and ensure uninterrupted production.
- Lead commissioning, qualification, and validation (CQV) activities, including FAT and SAT.
- Provide hands‑on oversight of biochemical systems, using root‑cause analysis to resolve equipment failures or yield deviations.
- Author and enforce SOPs, work instructions, and safety protocols (LOTO, confined space, PSM).
- Manage a flexible Management of Change (MOC) framework to accommodate frequent R&D‑driven recipe changes.
- Oversee on‑site laboratory/QC to deliver rapid analytical support for fermentation metrics.
Required profile
- B.S. or advanced degree in Chemical Engineering, Biochemical Engineering, or a closely related field.
- 7+ years progressive operations management experience in biochemical or specialty chemical manufacturing, with proven startup leadership.
- Demonstrated experience hiring, structuring, and leading multi‑disciplinary operational teams.
- Ability to be based on‑site or travel up to 100% during commissioning and initial production phases.
Required skills
- Aerobic/anaerobic fermentation and aseptic processing.
- Downstream purification dynamics.
- P&ID development, PFD creation, and HAZOP leadership.
- Root Cause Analysis (RCA) for equipment and yield issues.
- Standard Operating Procedures (SOP) authoring and enforcement.
- Management of Change (MOC) framework implementation.
- Commissioning, Qualification, Validation (CQV) including FAT and SAT.
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Published 12 hours ago
Expires 1 month from now
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bluestem-biosciences
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