Senior Supervisor, Biomanufacturing

Catalent•Madison, WI

9h•Onsite

About The Position

The Senior Supervisor, Biomanufacturing will supervise downstream biomanufacturing operations for mRNA and monoclonal antibody (mAb) production within a cGMP-compliant cleanroom environment. This role involves leading a team of technicians and associates, providing hands-on guidance, and supporting their professional growth. The supervisor will ensure operational readiness, meet production schedules, and drive continuous improvement by refining staffing models and workflows. A key aspect of this role is overseeing training on regulatory compliance, documentation standards, and cleanroom procedures, reinforcing GMP, GDP, deviation management, and data integrity. The supervisor will also represent downstream operations during audits, act as a technical liaison, and manage/optimize downstream unit operations using specific systems and equipment. Additionally, the role involves authoring and reviewing controlled documents, executing daily reviews of manufacturing documentation, serving as a Subject Matter Expert (SME) for downstream unit operations, maintaining Quality Systems, leading deviation investigations, supporting validation activities, and promoting a strong safety culture.

Requirements

Bachelor’s degree in Chemical Engineering
3 years of experience in job offered or 3 years of experience in the Related Occupation
Follow cGMP (current Good Manufacturing Practice), GDP (Good Documentation Practice), SOPs (Standard Operating Procedures), and GLP (Good Laboratory Practice) during all manufacturing and laboratory activities to ensure compliance with FDA, site, and regulatory standards.
Execute batch operations and analytical testing procedures according to approved BPRs (Batch Production Records) and validated laboratory methods with a focus on accuracy and right-first-time results.
Document all work in real time in BPRs, laboratory notebooks, logbooks, and controlled forms, ensuring traceability, data integrity, and audit-ready records.
Operate, calibrate, and troubleshoot analytical instruments, including analytical balances, pH meters, and chromatography systems/instruments, as applicable; perform product concentration/content analysis and measure key parameters (e.g., pH, conductivity, purity/identity) using calibrated instruments.
Perform raw-material, in-process, and finished-product sampling and testing to verify conformity with quality and regulatory specifications.
Contribute to batch disposition by providing accurate test results, supporting documentation, and compliance records to QA (Quality Assurance) for final review and approval.
Recognize non-conforming conditions or out-of-specification (OOS) results and report findings through the appropriate quality channels to ensure timely investigation and corrective action.
Maintain clean, aseptic, and controlled production and laboratory environments through proper gowning, sanitization, contamination control, and chemical hygiene.
Perform environmental and equipment monitoring, including temperature and humidity tracking, stability chamber logs, and assisting with stability study protocols.
Participate in internal and external audits or regulatory inspections by providing records, demonstrating procedures, and supporting compliance investigations.
Support continuous improvement initiatives by suggesting workflow efficiencies, reducing waste, optimizing processes, and improving repeatability of testing or manufacturing steps; prepare basic trends/trackers (e.g., for critical parameters, test turnaround time, and recurring deviations) to highlight opportunities for improvement.
Train or assist new staff members in SOPs, safety procedures, equipment/instrument operation, and documentation standards to ensure consistent, compliant execution.
Follow all EHS (Environmental Health & Safety) requirements, including proper chemical handling, biological safety, PPE use, hazardous waste disposal, and review SDS (Safety Data Sheets) to maintain a safe working environment; perform pre-task risk checks (SDS review, required PPE, ventilation/BSC use, chemical compatibility, and waste-stream selection).

Responsibilities

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, provide hands-on guidance during purification operations and support 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 Good Manufacturing Practice (GMP), Good Documentation Practices (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 (e.g., Persons In Plant), communicate technical and engineering justifications for processes.
Provide guidance and coach 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 SciLog skids for filtration and fluid management, apply 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, ensure 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, ensure 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) platform 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, apply 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 TrackWise and Electronic Document Management Systems (EDMS).
Lead execution and support of validation activities, including clinical runs, process performance qualification, and commercial campaign readiness, ensure all purification processes meet regulatory and engineering requirements.
Lead and support continuous improvement initiatives by analyzing process data trends, implement lean engineering tools (e.g., Kaizen, Six Sigma), and drive enhancements in yield, throughput, and compliance across downstream mRNA and mAb platforms.
Promote a strong safety culture by implementing the five blockers for incident prevention, reinforce hazard recognition and safe work practices, and foster team awareness of Safety Data Sheets and site safety requirements to ensure a safe and compliant manufacturing environment.