Senior Supervisor, Biomanufacturing

Senior Supervisor, Biomanufacturing

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.

Requires a Bachelor's degree in Chemical Engineering and 3 years of experience in job offered or 3 years of experience in the Related Occupation.

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

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Catalent is an Equal Opportunity Employer, including disability and veterans.