Cell Therapy Manufacturing Lead

Job Description

10 hours/day Wednesday – Saturday schedule.

Availability on weekends is a must.

JOB SUMMARY

The Cell Therapy Manufacturing Lead is part of the Excellos manufacturing team that supports the production of cell therapy products. The Cell Therapy Lead will be a subject matter expert for GMP aseptic cell culture activities in a cleanroom environment. They are responsible for all cell related tasks to produce cell-based products including but not limited to specialized customer manufacturing, developing relevant SOPs, and contribute to process validations. Leads and assists the Cell Therapy team with the manufacturing of cell products including blood, cryo product storage, organization, product distribution, and training.

RESPONSIBILITIES

• Lead trainer and mentor to manufacturing associates in alignment with cGMP requirements.

• Extensive experience in aseptic technique, clean room gowning and have knowledge of Good Manufacturing Practices (GMPs).

• Allocates daily work activities and roles for staff to meet production demands.

• Experienced in decision making, troubleshooting, investigation, and root cause analysis.

• Proactively identifies and assesses equipment issues, material shortages, and communicates issues to area management and cross-functional support teams.

• Actively write, revise, review SOPs, forms, and on the job-training documents.

• Performs essential laboratory responsibilities according to established procedures and other controlled documents.

• Assists with Cell therapy production activities including assays, sets up samples for testing (Cell Concentration, sterility, viability).

• Responsible for department/quality control records, review of test results, and statistical data.

• Prepares and ships biological samples and manufactured products.

• Provides updates on department projects and production objectives.

• Ensure staff updates all documentation and data collection bases.

• Assist with the weekly maintenance/cleaning of equipment and cleanroom.

• Works collaboratively with internal and external cross-functional teams.

• Participates in interviewing and training, and/or corrective action of direct reports.

• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.

• Participates in department meetings and educational programs.

• Supports the Excellos safety, GMP and Quality Plan.

• Responsible for maintaining laboratory proficiency and audit readiness.

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.

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

• 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/sit 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 up to 40 pounds.

EQUIPMENT USED

• Laboratory processing equipment (examples include, but are not limited to centrifuges, heat sealers, sterile connecting devices, biosafety cabinets, cell counters, hematology analyzer, 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 biology or related field with 5+ years’ experience or an equivalent combination of education and experience.

Experience:

• Biotechnology industry with 5+ cell culture and/or bioreactors in a GMP environment experience is preferred.

Skills:

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

• Extensive experience in standard cell culture methods including cell counts using Hemocytometer, perform calculations including cell concentration determination, seeding densities, % viability, weight measurements, and volume.

• The ability to collect, compile and analyze a variety of data, and use to draw conclusions.

• Ability to identify potential equipment or process issues.

• Ability to organize information for multiple, concurrent projects.

• 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.

The above statements are intended to describe the general nature and level of work being performed. This job description is not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.