Find More Than 10K+
United Kingdom Jobs

Excellos is a unique full-service CDMO that pairs the collection and characterization of critical human cells and tissues with manufacturing and development services to drive innovation in the cell and immunotherapy industry. Built on the foundation of the San Diego Blood Bank (SDBB), Excellos is focused on supplying cGMP cellular products and services, together with process development and manufacturing expertise to scientists and clinicians working with cell and gene therapies. Excellos’ experience includes working with therapeutic companies developing chimeric antibody receptor-engineered T cells (CAR-T), tumor-infiltrating lymphocytes (TIL’s), and providing isolated immune cells that are integral to the advancement of immunotherapies. Excellos is dedicated to improving human life by leveraging donor populations for life science research and the next generation of cell and immunotherapies. Our goal is to facilitate the advancement of cellular therapies and help fully realize the potential of these powerful therapeutics, saving lives today and improving life tomorrow.

JOB SUMMARY

The Manufacturing Associate II or III, Tissue and Cell Therapy is responsible for performing well regulated GMP aseptic cell culture activities including media preparation, cell thaws, cell expansion, cell harvesting, and cryopreservation using standard cell culture technologies in a cleanroom environment. The Associate will be responsible for following Batch Production Records, Standard Operating Procedures, and work instructions in manufacturing spaces. The Associate will be responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.

Hours: 4 - 10 hour shifts per week

RESPONSIBILITIES

• Experience in aseptic technique, clean room gowning and have knowledge of Good Manufacturing Practices (GMPs).
• Documenting of each task, understanding verifier versus operator functions, following cleaning procedures, and ensuring aseptic processing techniques.
• Daily updating of Production spreadsheets, review of completed documents, addressing corrections, and communication of document readiness to management.
• Responsible for documenting deviations and reporting deviations to department management
• Receipt and processing of blood, cord, blood, and tissue collection processes under cGMPs.
• Execution of colony forming units assay procedures (CFUs), set up samples for sterility testing, performs flowcytometry assays for viability and cell identification.
• Responsible for execution of cell culture manufacturing: cell thawing, cell passaging, cell feeding, harvesting, cell counting, cryopreservation, and stability testing.
• Performs sample processing, intermediate formulations, storage, and distribution of product
• Operation of supporting equipment for daily manufacturing.
• Train on and actively participate in revising of Standard Operating Procedures (SOPs), Batch Production Records (BPRs), Work Instructions, and Forms.
• Supports environmental monitoring processes including personnel monitoring, suite monitoring as defined by the facility
• Assist with the weekly maintenance/cleaning of equipment and cleanroom to support GMP production.
• Assist Subject Matter Expert (SME) with providing training for new and existing employees.
• Assist with the ordering, stocking, release of supplies/materials to meet production demands
• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.
• Help identify potential equipment or process issues.
• Supports the Excellos safety, GMP and Quality Plan.
• Participates in department meetings, proficiency testing, and educational programs.

WORKING ENVIRONMENT

• Normal laboratory environment with biohazard precautions.
• Must work with living human cells and various chemicals.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• May be exposed to hazardous chemicals.
• Will be working with liquid nitrogen.
• May be called on to workdays or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if necessary.

PHYSICAL REQUIREMENTS

• Must be able to stand long hours.
• Must be able to sit at biosafety cabinet for hours, while aseptically manipulating product.
• Must be able to communicate clearly.
• May be required to lift 50 pounds.

EQUIPMENT USED

• Laboratory processing equipment (examples include, but are not limited to: centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, 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:

• Bachelor’s degree in cell biology or related field with 1+ years industry experience

or

• Associate degree in related area and/or a Biotech Program certificate from an accredited college with 2+ years industry experience.

Skills:

• Strong understanding of aseptic technique and Good Manufacturing Practices (GMP).
• Proficient in standard cell culture methods including cell counts using Hemocytometer, perform calculations including cell concentration determination, seeding densities, % viability, weight measurements, and volume.
• Interpersonal skills to establish professional relationships both internally and externally.
• Critical thinking, creativity, and innovative thinking.
• Detail oriented with the ability to set priorities and organize daily work requirements.
• Must be able to work both as a team member and independently, as required.
• Proficient in professional communication both written and oral, which is clear and precise.
• Must keep Management informed on any technical and/or operational issues that arise.
• Must be flexible, as production priorities, timelines, and processes can change regularly.
• Integrity and discretion – ability to maintain confidentiality.
• Ability to perform under pressure and work under stressful situations.

Certifications/Licenses:

• Biotech certificate valued, not required