Cell Therapy Manufacturing Associate I

OrganaBio•San Diego, CA

23h•$27 - $30•Onsite

About The Position

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).

Requirements

Laboratory experience with working knowledge of basic lab procedures.
Previous experience with sterile technique and handling human biospecimens.
Basic understanding of aseptic technique and Good Manufacturing Practices (GMP).
Ability to work under minimal supervision.
Ability to perform calculations including cell concentration determination, % viability, weight measurements, and volume.
Interpersonal skills to establish and maintain professional relationships both internally and externally.
Ability to work collaboratively as a member of a team and to communicate effectively within an interdisciplinary environment.
Ability to work well under pressure and meet critical timelines.
Ability to work, learn, adapt, and execute in a fast-paced commercial environment.

Nice To Haves

An Associates degree in science related field is preferred.
Familiarity with standard cell culture methods is preferred Excellos will train an acceptable candidate
Biotech certificate valued, not required

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.