Job Summary

The Research and Cord Blood Manufacturing Technician II is responsible for completing and assisting with daily tasks associated with the processing of cord blood units in a clean room manufacturing environment. The Research and Cord Blood Manufacturing Technician II will be responsible for maintaining and working in Good Manufacturing Practice (GMP) ISO7 and ISO8 manufacturing spaces, as well as certified ISO5 biosafety cabinets and controlled, supportive laboratory areas. The Research and Cord Blood Manufacturing Technician II will be responsible for participating in the maintenance of critical supplies, equipment, product testing, product storage and product distribution.

Responsibilities

• Adheres to the Food and Drug Administration (FDA) current good manufacturing practice (cGMP) and current good tissue practice (cGTP) regulations and guidance.
• Maintains client, donor, and research subject confidentiality.
• Manufactures umbilical cord blood in a clean room environment, following proper gowning protocol and using aseptic technique.
• Expected to maintain facility-defined gowning qualification.
• Performs repetitive tasks, while maintaining attention to detail.
• Maintains the clean room environment following cleaning procedures and including implementation and support of environmental monitoring processes defined by the facility.
• Acts as operator/verifier in manufacturing, following Batch Production Records (BPRs) and Standard Operating Procedures (SOPs).
• Understands and documents detailed manufacturing steps per BPR and recognizes when deviations or incidents are to be documented.
• Participates in conducting and documenting quality incident investigations related to manufacturing.
• Supports and participates in research and investigational studies. 
• Provides feedback and support in drafting and implementing documents and procedures for department development/process improvement.
• Supports the SDBB safety, GMP and Quality Plan.
• Participates and assists in the maintenance of equipment and supplies in support of manufacturing.
• Assists with the order and release of critical manufacturing materials to meet changes in production demand.
• Maintains department records, reports and statistical data, as required.
• Initiates Quality Incident Reports and deviations, as required.
• Cryopreserves, stores and distributes products per BPRs/SOPs.
• Assists with training of personnel in cGMP production procedures, as necessary.
• Performs colony forming units assay procedures (CFUs), performs cell counts (using various methods), sets up samples for sterility testing, performs flowcytometry assays for viability and cell identification.
• Utilizes applicable computer hardware and software systems.
• Maintains a safe work environment.
• Participates in department meetings, educational programs and other meetings as assigned.
• Participates in proficiency testing as applicable.
• Understands and adheres to the policies and standards as developed as part of the San Diego Blood Bank Compliance Program.
• Performs other related duties as assigned or requested.

Working Environment

• Normal laboratory environment with biohazard precautions.
• Exposure to blood borne pathogens.
• May be exposed to hazardous chemicals.
• Will be working with liquid nitrogen.
• May be called on to work on days or hours other than routinely scheduled hours, work overtime hours, or potentially work through breaks, if necessary.
• Environment requires that gowning in the form of scrubs, bunny suits/gowns, hoods, gloves, sleeves, boot covers, and face masks be worn when entering cleanroom. 
• No makeup or jewelry can be worn when working in a cleanroom environment.

Physical Requirements

• Must be able to stand long hours.
• Must be able to sit at biosafety cabinet for hours, while aseptically manipulating product
• May be required to lift up to 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, , hematology analyzer, cell separators).
• Standard office equipment such as: computers, telephones, copy machines, fax machines and scanners.
• General laboratory equipment (examples include, but are not limited to: barcode scanners, scales, shippers, centrifuges, refrigerators, freezers).

Qualifications

Education:

• Associate Degree in life sciences, microbiology, or other related field/discipline from an accredited college or university or equivalent combination of education, training and/or experience
• Bachelor’s Degree from an accredited college or university preferred.

Certifications/Licenses:

Experience:

• Minimum of 2 years of experience, preferably in a cGMP/regulated environment.
• Experience with sterile and/or aseptic manufacturing is required.
• Experience with cord blood product processing, storage, and distribution, with exposure to cord blood banking and hematology, preferred.

Skills:

• Strong understanding of aseptic technique and Good Manufacturing Practice (GMP) and Good Tissue Practice (GTP).
• Must be able to perform calculations such as cell concentrations, seeding densities, dilutions, percentages, weight measurements and volumes.
• Ability to organize information for multiple, concurrent projects.
• Interpersonal skills to establish and maintain 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.
• Ability to work independently as well as part of a team.
• 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 able to manage multiple and rapidly changing priorities and have ability to quickly learn new skills and concepts.
• Integrity and discretion – ability to maintain confidentiality.
• Ability to perform under pressure and work under stressful situations.

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.