Manufacturing Operations / Production Supervision (Upstream Processing) — M2

Focus — Manufacturing Operations / Production Supervision (Upstream Processing)

Frontline-to-departmental leadership of GMP upstream biomanufacturing operations (seed expansion, bioreactor/cell culture, harvest). Distinct from downstream purification supervision and from the individual-contributor MSAT/technical-owner track: this family owns shift-and-stream execution, schedule adherence, 'Right First Time' batch production, compliance, equipment readiness, and people management for upstream production.

Responsibilities by level

What this person actually does at each level on the management track — escalating scope, not one generic blob. Your level is highlighted.

Level guidelines

The universal leveling rubric applied to this function — how scope, complexity, collaboration, and experience step up across levels.

Skills

Focus-specific skills the role applies — the relevance layer beyond the occupational base.

People Leadership

Supervising, coaching, mentoring and training team members and managing shift performance.

Production Scheduling

Planning, assigning and monitoring daily tasks to ensure schedule adherence and timely execution.

GMP Compliance

Executing tasks in strict accordance with manufacturing records, SOPs and current Good Manufacturing Practices and quality regulations.

Deviation/CAPA/Change Control Management

Authoring, reviewing and approving manufacturing deviations, corrective and preventive actions, and change controls within the quality system.

Bioreactor/Fermenter Operation

Preparing, calibrating and controlling stirred-tank and single-use bioreactors (HyPerforma S.U.B/DynaDrive, Biostat STR, Xcellerex XDR, wave bioreactors) for seed expansion and fed-batch production, monitoring growth parameters.

Upstream Processing Equipment Operation

Working knowledge of incubators, biosafety cabinets, bioreactors, cell counters (Vi-Cell), blood gas analyzers, Cedex Bio and metabolite testing equipment used in cell culture/fermentation.

Cell Counting / Culture Health Assessment

Counting cells during growth and comparing living and dead cells to measure culture health as a critical process parameter.

Aseptic Technique

Critical practice for preventing contamination using special procedures to maintain sterility and minimize product exposure to the environment in cleanroom settings.

Cleanroom Discipline

Application of controls for aseptic processing including gowning and cleaning to maintain sterile manufacturing conditions.

Good Documentation Practices

Documenting each task in records and logbooks at the time of execution in compliance with GMP.

Batch Record Authoring

Writing and reviewing SOPs and Master Batch Records to define manufacturing operations.

Statistical Data Analysis

Intermediate knowledge of statistical data analysis and process data trending of CPPs (pH, DO, VCC, viability) to enhance process understanding.

Production Equipment Qualification

Specifying, commissioning and qualifying new upstream equipment for GMP production readiness.

Cell Culture Science

Knowledge of cell biology, cell culture, scale-up and mass transfer, and culture health monitoring via viable cell concentration and viability.

Technology Transfer

Bridging Process Development and Manufacturing to enable tech transfer, process validation and sustained commercial manufacturing.

Provenance

The evidence base behind this profile — every layer is sourced; quality is scored by an adversarial review panel (1–5; passes at ≥4 on the minimum dimension).