Biomedical Technician - GMP Manufacturing

Cedars-Sinai; West Hollywood (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Cedars-Sinai seeks a Biomedical Technician to support wet- and dry-lab projects in the CBC. You will perform process development tasks, maintain equipment, and ensure documentation per SOPs and regulatory guidelines.

Responsibilities include sample verification, inventory management, and collaboration with cross-functional teams to troubleshoot and address issues in a GMP-like environment. A biology/biochem background is preferred.

Qualifications

• 1 year of lab/biotech experience required.
• Must be able to document in lab notebooks, SOPs and batch records.
• Knowledge of regulatory requirements (FDA, Federal, State).
• Familiar with routine lab procedures and experimental protocols.

Responsibilities

• Performs process development tasks for multiple clients following SOPs; tasks vary by project.
• Writes and maintains documentation in lab notebooks, data records, SOPs, and batch records.
• Drafts SOPs and maintains the computer database.
• Verifies samples, logs them into systems, and may transport to storage per SOPs.
• Performs lab maintenance, including glassware cleaning and sterilization.
• Maintains lab equipment and related records.
• Prepares and maintains material inventories; places orders for equipment.
• Assists in operating specialized equipment and machinery.
• Ensures activities comply with regulatory guidelines and safety standards.
• Interacts with core lab customers professionally and communicates clearly.

Skills

Lab experience

Biomedical equipment maintenance

Interpersonal/communication

Regulatory knowledge

Computer skills (Excel/Word/PowerPoint

Documentation (notebooks/SOPs)

Education

Assoc. degree/College diploma in biology/biochemistry or related field

Bachelor's degree preferred

Tools

Laboratory equipment

Job description

Job Description

With your help, we can change the future of healthcare!

The Cedars-Sinai Biomanufacturing Center (CBC) is a state-of-the art facility that comprises of a cGMP cell manufacturing facility housing multiple cleanroom cell production suites and process development rooms for producing the next generation of cell and gene therapies. With world class expertise in stem cell (iPSC) biology, bioprocessing, translational, regulatory and manufacturing, Cedars-Sinai is committed to pushing the frontiers of medicine and discovering new technologies and innovations that will impact how we diagnose and treat disease. To learn more about the CBC, please visit Home - CSBIO (csbiomfg.com).

Are you ready to be a part of breakthrough research?

The Biomedical Technician participates on wet- and dry- laboratory projects and may execute tasks requiring compliance with all Federal and State accrediting agency requirements and/or GLP. Responsible for assigned wet lab work, lab maintenance, and writing and recording controlled documents. Performs all activities strictly according to SOPs, with accurate documentation, and may assist quality control team with required testing activities. Installs and maintains laboratory equipment to ensure proper functioning of devices. Assists in addressing complex issues and troubleshooting.

Primary Duties and Responsibilities

• Performs a variety of process development tasks for multiple clients following standard operating procedures that will be different for each project based on the type work.
• Writes and maintains good documentation in laboratory notebooks, data record/transfer, SOPs, and batch records.
• Drafts standard operating procedures and maintains computer database.
• Verifies samples received, logs samples into systems, and may transport to appropriate environment within the facility for storage following SOPs.
• Performs lab maintenance duties, including glassware cleaning and sterilization.
• Maintains lab equipment and related records.
• Prepares and maintains material inventories, and places orders for equipment and supplies.
• Assists in the operation of specialized equipment and machinery.
• Ensures all activities comply with regulatory guidelines and safety standards, as appropriate.
• Interacts with core laboratory customers with professionalism and respect and communicates effectively with the customers.

Qualifications

Education

• Assoc. Degree/College Diploma in biology, biochemistry or related science/engineering field is required. Bachelor's degree is preferred.

Experience and Skills

• One (1) year of experience working in a lab or biotech environment and biomedical equipment such as maintenance or testing is required.
• Ability to simultaneously manage multiple clerical trials, and attention to details.
• Must have superior interpersonal, communication and organization skills and the ability to work across company disciplines and functional units, and computer application experience.
• Knowledge of regulatory requirements including Federal, FDA, State, and accrediting agency requirements.
• Familiar with routine laboratory procedures, experimental protocols, and overall lab organization.
• Knowledge of specialized equipment.
• Collaborates to problem solve and make decisions to achieve desired outcomes.
• Ability to use databases. Must possess computer skills to include, but not limited, to Excel, Word, and PowerPoint.
• Responds timely, effectively and appropriately to deliverables.
• Responds to emergency calls in order to troubleshoot malfunctions of equipment and able to correct the problem quickly.
• Establishes effective working relationships with cross-functional team(s).