Senior Supervisor,Biomanufacturing Job Madison area,Wisconsin USA,Engineering

Job Title, City, State

Senior Supervisor, Biomanufacturing – Madison, WI

Job Description

Supervise downstream biomanufacturing operations for mRNA (including In Vitro Transcription/IVT) and monoclonal antibody (mAb) production within a cGMP‑compliant cleanroom environment, ensuring high‑yield, on‑spec product output.

Lead a team of technicians and associates with technical or scientific backgrounds, providing hands‑on guidance during purification operations and supporting long‑term professional growth through structured training programs, skills development, and individualized career development plans.

Ensure operational readiness for batch manufacturing, deliver on production schedules, and promote continuous improvement by refining staffing models and workflows to align with client requirements and financial objectives.

Oversee targeted training on regulatory compliance, documentation standards, and cleanroom procedures, reinforcing GMP, GDP, deviation management, and data integrity requirements to ensure consistent and compliant manufacturing execution.

Represent downstream operations during audits and inspections, including FDA and client audits; act as technical liaison for external visitors, communicating technical and engineering justifications for processes.

Provide guidance and coaching to ensure adherence to cleanroom standards, including gowning, 5S practices, equipment cleaning, and waste management protocols.

Manage and optimize downstream unit operations using AKTA XL systems controlled by UNICORN software and Sci Log skids for filtration and fluid management, applying engineering principles and process control concepts to ensure accurate system setup, operation, and data integrity. Oversee a wide range of processing equipment, including peristaltic pumps, single‑use mix tanks (SUMs), pH/conductivity meters, biosafety cabinets (BSCs), laminar flow hoods (LFHs), and other critical systems to support compliant purification and concentration of mRNA and mAb products in accordance with cGMP standards.

Author, review, and revise Standard Operating Procedures (SOPs), Batch Production Records (BPRs), and Job Aids (JAs) to ensure alignment with current cGMP, data integrity (ALCOA+), and safety standards. Collaborate with cross‑functional teams to incorporate process updates, regulatory requirements, and best practices into controlled documents, ensuring clarity, accuracy, and ease of execution for manufacturing personnel. Maintain document version control and support periodic reviews and training implementation.

Execute daily review of completed manufacturing documentation for data accuracy, traceability, and adherence to Good Manufacturing Practice standards. Analyze process data to identify trends, provide technical guidance for troubleshooting, and assign team members to resolve identified issues efficiently.

Serve as the Subject Matter Expert (SME) for biopharma‑specific downstream unit operations, including chromatography (affinity, ion exchange), ultrafiltration/diafiltration (UF/DF), and IVT‑related purification steps, ensuring consistent application of engineering and scientific principles during tech transfer, validation, and commercial production.

Maintain the effectiveness of Quality Systems by using DeltaV (Distributed Control System) and Ignition (SCADA/HMI) platforms for real‑time automation, data acquisition, and control of cleanroom and unit operations. Ensure critical parameters—including flow rate, differential pressure, temperature, and humidity—remain within validated operating ranges to support consistent product quality.

Lead deviation discussions and drive investigations of deviations and failures, applying root‑cause analysis tools (e.g., 5 Whys, cause and effect) and engineering problem‑solving methodologies; support implementation of corrective and preventive actions and change controls through systems including Track Wise and Electronic Document Management Systems (EDMS).

Lead execution and support of validation activities, including clinical runs, process performance qualification, and commercial campaign readiness, ensuring all purification processes meet regulatory…