Cell Therapy Manufacturing Associate I

JOB SUMMARY

The Cell Therapy Manufacturing Associate I is responsible for performing routine cell isolation and cryopreservation procedures under Good Laboratory Practices (GLP) and current Good Manufacturing Practices (cGMP). The Associate will be responsible for performing operator and verifier activities following Batch Production Records (BPR) and Standing Operator Procedures (SOP).

RESPONSIBILITIES

•Operates under GLP and cGMP manufacturing conditions.

•Perform routine manufacturing tasks, including media preparation, cell isolation, cell counting, formulation, centrifugation, and freezing.

•Responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.

•Complete and ensure timely, accurate documentation in compliance with GMP standards across batch records, forms, and protocols

•Performs routine maintenance and cleaning of lab equipment and environment.

•Performs laboratory testing utilizing various analytical techniques including flow cytometry and cell counting.

•Performs ordering, stocking, and release of supplies/materials to maintain supply inventory levels.

•Handles finished goods inventory and prepares cellular products and relevant documentation for shipment to customers.

•Receives and processes cord blood and leukapheresis materials under cGMP and GLP.

•Analyzes and performs calculations to assess results of manufacturing processes.

•Responsible for accurate documentation of laboratory tasks in compliance with Excellos Labs’ quality plan and Good Laboratory Practices.

•Responsible for daily updating of manufacturing spreadsheets, review of completed documents, addressing corrections, and communication of document readiness to management.

•Responsible for documenting and reporting deviations to department leadership.

•Adheres to production schedules to ensure on-time production logistics and fulfillment of client requests.

•Participate in departmental and organizational projects and meetings and educational programs.

WORKING ENVIRONMENT

•Must work with living human cells and various chemicals.

•ISO 7 and ISO 8 clean room facilities, including sterile gowning garments

•Normal laboratory environment with biohazard precautions.

•Must work with living cells, various chemicals, and liquid nitrogen.

•May be exposed to blood or bodily fluids that may be capable of transmitting diseases.

•May be exposed to hazardous chemicals.

•May be called on to work or attend meetings at other than routinely scheduled hours.

PHYSICAL REQUIREMENTS

•Must be able to stand or sit long hours.

•Must be able to work on a computer 4 - 8 hours a day.

•Must be able to communicate clearly.

•May be required to lift up to 40 pounds.

EQUIPMENT USED

•Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, automated cell counters, flow cytometers, incubators, bioreactors, cell separators).

•Normal office equipment such as: telephone, computer, cell phone, printer, copier, fax, scanner.

•General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, refrigerators, freezers).

QUALIFICATIONS

Education:

o An Associates degree in science related field is preferred.

Skills:

oLaboratory experience with working knowledge of basic lab procedures.

oPrevious experience with sterile technique and handling human biospecimens.

oFamiliarity with standard cell culture methods is preferred Excellos will train an acceptable candidate

oBasic understanding of aseptic technique and Good Manufacturing Practices (GMP).

oAbility to work under minimal supervision.

oAbility to perform calculations including cell concentration determination, % viability, weight measurements, and volume.

oInterpersonal skills to establish and maintain professional relationships both internally and externally.

oAbility to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.

oAbility to work well under pressure and meet critical timelines.

oAbility to work, learn, adapt, and execute in a fast-paced commercial environment.

Certifications/Licenses:

oBiotech certificate valued, not required

This position works 4 x 10 hour days: Tuesday - Friday.

Salary range: $26.50 - $29.50 per hour