Manufacturing Lead - Shift B

The Lead, Manufacturing Operations 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.

The Lead, Manufacturing Operations will primarily be responsible for manufacturing operations of Train 2. Train 2 is a production line going from vial thaw in initial thaw and expansion to a 500L production reactor, followed by harvest, to finishing operations in downstream.

Example Plan Shifts/Training Schedule:

- First 2 weeks: 8 hour shifts, M-F

- Next 1-2 months: 10 hour shifts, Mon-Thurs

- After 90 days: 12 hour shifts, Thurs-Sat & Alternating Wednesdays

Schedule is subject to change based on needs.

Responsibilities

Manufacturing Operations Individual Skills

• Provide hands-on training for upstream staff to ensure compliance with training on all activities prior to GMP execution.
• Adhere to appropriate gowning procedures required for working in Class 10,000 and Class 100,000 cleanrooms.
• Perform operations in a bio-safety cabinet using aseptic technique and maintain asepsis of all closed container sterile processes.
• Perform upstream production activities including thawing of cell stocks, inoculum train expansions, cell culture maintenance in bioreactors, depth and sterile filtration, and master cell bank and bulk drug substance fills.
• Monitor processes and results and troubleshoot issues as they arise to ensure process success.
• Lead and guide associates through process and workflow improvement initiatives.
• Lead batch readiness activities such as general planning and coordination, material requests and transfer, and material and equipment staging.
• Setup, operate and maintain downstream bioprocessing equipment including AKTA ready column chromatography skids, FlexAct automation skids, large scale filtration skids, and analytical instruments such as SoloVPE.
• Perform downstream production activities including depth filtration, purification by affinity, ion exchange, and hydrophobic interaction chromatography, viral inactivation and filtration, tangential flow filtration, sterile filtration, and bulk drug substance fills.
• Enforce cleanroom standards for cleanliness and order
• Direct floor operations for multiple projects simultaneously.
• Make adjustments as necessary to adhere to production schedules.
• Cross-train on various tasks including autoclaving of assemblies, formulation of buffers, and Downstream operations to support overall success of the Biologics group.
• Represent departmental activities as needed, including project teams and task forces.
• Review GMP records for completeness, accuracy, and compliance on a daily basis in conformance with regulatory requirements.
• 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 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.
• Support media and buffer preparation, inoculum expansion, bioreactor operations, harvest, chromatography, UF/DF, sterile filtration, and bulk drug substance filling.
• 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.
• Support deviations, CAPAs, change controls, and quality events.
• Troubleshoot process, equipment, and operational issues.
• Champion EHS compliance and safe work practices.
• Partner with QA, QC, MSAT, Engineering, Facilities, Supply Chain, and Program Management.

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.

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

• Provide technical oversight for upstream and downstream operations.
• 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.

Travel between Abzena sites (local San Diego CA facilities ) as needed.

Physical Requirements

• Ability to stand for 1-2 hours at a time, sit for 2 to 3 hours at a time.
• Frequently lift and or move objects at least 30 pounds in weight.
• Stand/walk during entire length of shift.
• Use arms, hands and fingers to handle, feel or reach.
• Ability to climb, balance, stoop, kneel, crouch, or crawl.
• Visual abilities including near and far sight, color, peripheral vision, depth and ability to focus.