Lead, Manufacturing Operations

The Lead, Manufacturing Operations (Shift B) is responsible for serving as the subject matter expert and operational lead within GMP manufacturing operations supporting biologics production. This role provides day-to-day directional leadership, coordination, and training for manufacturing personnel involved in upstream and downstream processing activities, including cell culture expansion, bioreactor operations, harvest, purification, filtration, and bulk drug substance manufacturing. The Lead supports batch execution, training, process troubleshooting, documentation review, and operational readiness activities.

Responsibilities

Manufacturing Operations Individual Skills

• Adhere to appropriate gowning procedures required for working in ISO 5 - ISO 8 cleanrooms.
• Perform aseptic operations in a bio-safety cabinet.
• Setup, operate and maintain upstream bioprocessing equipment including single-use bioreactors up to 2000 L, large scale filtration skids, and automated filling machines and analytical instruments for cell culture such as Nova Bioprofile and Vi-Cell systems.
• Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, cell culture harvests, and master cell bank and bulk drug substance fills.
• Monitor processes and results and troubleshoot issues as they arise to ensure process success.
• Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, large scale filtration skids, and analytical instruments such as SoloVPE.
• Perform downstream production activities including depth filtration, purification through various modes of chromatography, viral inactivation, viral filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
• Enforce cleanroom standards for cleanliness and order.
• Cross-train on various tasks including formulation of buffers, facility cleanings, and other operations to support the overall success of the Manufacturing organization.
• Represent departmental activities as needed, including project teams and task forces.
• Review executed GMP records on a daily basis for completeness, accuracy, and compliance.
• Draft, revise and review manufacturing SOPs, master batch records, specifications, and other applicable cGMP documentation.
• Adhere to quality standards set by regulations and Abzena policies, procedures, and mission.
• Operate to the highest ethical and moral standards.
• Adjust to a flexible work schedule including weekend work, as needed.
• Perform additional duties as assigned.

Manufacturing Operations Leadership

• Lead and support day-to-day execution of upstream and downstream GMP manufacturing activities.
• Coordinate manufacturing floor activities and provide real-time direction to manufacturing associates during campaign execution.
• Ensure activities are performed according to approved batch records, SOPs, and production schedules.
• Provide hands-on training and qualification support for manufacturing personnel.
• Review GMP documentation for completeness, accuracy, and compliance.
• Troubleshoot process, equipment, and operational issues.
• Champion EHS compliance and safe work practices.

Team Leadership & Development

• Train Manufacturing Associates.
• Provide feedback and review of staff during performance evaluations.
• Facilitate onboarding and qualification of new employees.
• Promote a culture of safety, teamwork, accountability, and continuous improvement.
• Lead daily shift meetings, production reviews, and operational communications.
• Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging.

GMP Compliance & Quality

• Ensure strict compliance with cGMP regulations, company procedures, and regulatory requirements.
• Review and verify batch documentation for accuracy and completeness.
• Support investigations, deviations, CAPAs, change controls, and quality events.
• Participate in internal audits, client audits, and regulatory inspections.
• Ensure proper documentation practices and data integrity standards are maintained.

Process Execution & Technical Support

• Support process transfers from development to GMP manufacturing.
• Assist in process validation, engineering runs, and GMP campaign readiness activities.
• Collaborate with MSAT, Process Development, and Engineering teams to improve process robustness and efficiency.
• Troubleshoot manufacturing and equipment-related issues.

Safety & Operational Excellence

• Champion Environmental Health and Safety (EHS) compliance.
• Ensure safe handling of biological materials, chemicals, and manufacturing equipment.
• Lead risk assessments and support implementation of corrective actions.
• Drive Lean Manufacturing and continuous improvement initiatives.
• Monitor and improve key performance indicators (KPIs) including safety, right-first-time execution, batch success rate, and schedule adherence.

Cross-Functional Collaboration

• Partner with Quality Assurance, Quality Control, Validation, Facilities, Engineering, Supply Chain, and Program Management teams.
• Support customer visits and client-facing manufacturing discussions as required.
• Ensure manufacturing readiness through effective planning and material coordination.

Qualifications

• BA/BS degree that included laboratory work in a chemistry, biology, or related field.
• At least 3 - 4 years of purification experience in a GMP pharmaceutical/biotech environment role.
• Demonstrate knowledge and understanding of cGMPs and how they apply to responsibilities.
• Skilled in aseptic handling, including BSC operations to maintain the integrity of sterile systems.
• Skilled with using single-use technologies
• Strong technical and mechanical aptitude in bioprocessing.
• Knowledge of purification using column chromatography
• Experience leading, training, and coaching peers.
• Computer proficiency
• A proven ability to confidently compute basic arithmetic operations.