Lead Upstream Bioprocess Manufacturing Specialist

Skills at this level

Aseptic technique

— Performs sterile manipulation of cell culture during transfers, sampling and inoculation, working within a Grade A environment to prevent contamination of the culture.

Media preparation

— Prepares and sterilizes cell-culture media from stage-specific recipes, weighing and dispensing ingredients for each phase of the growth and production process.

Bioreactor operation

— Operates seed-train and production bioreactors from bench to production scale, controlling temperature, pH, dissolved oxygen and feed additions across batch and fed-batch culture modes.

CIP/SIP and equipment sterilization

— Assembles, cleans and sterilizes process equipment by executing clean-in-place and sterilize-in-place cycles per SOP, and verifies the equipment is ready for aseptic use.

Batch record execution

— Executes and documents Batch Production Records for upstream unit operations in real time, capturing weigh-outs, setpoints and in-process readings under Good Documentation Practices.

GMP and regulatory compliance

— Applies cGMP regulations and company SOPs to upstream manufacturing, maintaining clean-room controls and records that satisfy regulatory requirements.

In-process monitoring

— Monitors culture parameters during runs, recognizes drifts or excursions in pH, DO and temperature, and takes or escalates the correct procedural response.

Deviation and CAPA support

— Reconstructs floor-level events during deviation investigations and proposes corrective/preventive actions to stop process or equipment problems recurring.

Procedure authoring and training

— Drafts and qualifies new upstream SOPs, batch record templates and aseptic procedures, then trains and coaches operators on their correct execution.

Working lead / task coordination

— Coordinates equipment turnaround and shift task sequencing across the upstream suite and directs and verifies the work of less experienced associates without formal supervisory authority.

Teamwork and communication

— Collaborates on shift work teams and with QA, MSAT and engineering, communicating in-process status and handoffs where combined contribution and results are expected.