Senior Manager, Upstream Processing

Skills at this level

Cell Culture and Fermentation Operations

— Directs GMP execution of upstream unit operations — inoculation, seed expansion, inoculum flask steps, and bioreactor production runs — including validation and maintenance of production cultures and sterile materials preparation.

GMP and Bioprocess Safety Compliance

— Ensures manufacturing teams adhere to good manufacturing practices and safety protocols for handling hazardous materials and waste disposal, maintaining a clean, audit-ready upstream production environment.

Batch Record and SOP Governance

— Oversees authoring, review, and revision of SOPs, Batch Records, Logbooks, and On-The-Job Trainings, and directs review of Executed Batch Records to sustain right-first-time compliance.

Upstream Process Troubleshooting

— Diagnoses and resolves deviations arising during cell culture or fermentation, addressing manufacturing and process challenges to keep campaigns on schedule.

Control Strategy and Process Monitoring

— Applies molecule-specific control strategy, critical process parameters and attributes, and process monitoring tools to make data-driven decisions ensuring process consistency and robustness on the floor.

Technology Transfer to Manufacturing

— Leads introduction of new upstream processes into routine operations through startup, bridging process development and MSAT with the plant across the interface of quality, operations, and engineering.

Scale-Up and Manufacturability

— Directs scale-up of high-yield, robust, scalable cell culture and fermentation processes from lab to production scale, resolving the manufacturability problems escalated across development programs.

Process Validation and Comparability

— Owns upstream contribution to validation acceptance criteria, PPQ campaigns, material sampling and tech-transfer criteria, and comparability assessments supporting regulatory filings such as BLAs.

Commissioning and Qualification (C&Q)

— Supports C&Q of upstream bioprocess systems and unit operations — bioreactors, perfusion systems, and associated utilities — to establish qualified state for GMP production.

Continuous Improvement in Bioprocessing

— Identifies and drives improvements to cycle-time, consumable usage, and batch-record quality across upstream operations to raise throughput and reduce cost.

Team Training and Mentoring

— Builds upstream operator capability by training and mentoring colleagues in SOPs, process execution, and equipment operation, developing bench strength across the shift teams.

Materials and Consumables Management

— Coordinates availability of raw materials and consumables required for upstream manufacturing, aligning supply with the campaign schedule to prevent production interruption.

Upstream Operations Budget and Capacity Planning

— Owns operating and capital budgets, headcount, and campaign throughput for upstream areas, aligning capacity plans with site production and CMC commitments.