OrganaBio was founded in 2018 with the mission to become the hub for tissue sourcing, clinical sample processing and contract manufacturing services to support cell and gene therapy developers around the globe. At our core, we continually apply a data-driven approach with meaningful insights across our strategically located facilities to provide solutions to our clients where they need it most. Headquartered in Miami, Florida, OrganaBio delivers products and services that span the full development lifecycle – from proprietary tissue supply chains and cellular starting materials to expert development, testing, and other support services that expedite the path to clinical translation. This position will work at the newly formed OrganaBio subsidiary Excellos Labs, LLC (“Excellos Labs”) located in Downtown San Diego, California.

RESPONSIBILITIES

• Performs routine and non-routine environmental monitoring (EM) of Excellos Lab’s cGMP manufacturing facilities for total non-viable particulates, air viable particulates, and surface viable particulates per applicable standard operating procedures (SOPs).
• Safely operate and maintain all EM testing and laboratory equipment including validation, routine calibration, and preventive maintenance in accordance to established practices, SOPs, and test methodologies.
• Perform in-house enumeration including placing plates on test and movement between temperatures per assigned schedule.
• Coordinates shipment of collected samples to external laboratories.
• Responsible for timely completion of associated EM result summaries.
• Escalate any alert or action results to QC management.
• Assists and initiates the investigation and review of EM related quality events, including but not limited to EM excursions, deviations, non-conformances, and audit findings.
• Performs sampling for the gowning qualification program for all Excellos personnel.
• Reviews cleanroom EM data and assists in trending data and preparation of quarterly and yearly reports.
• Assists in development and revision of policies, standard operating procedures (SOPs) and other documents.
• Exhibits professional behavior with both internal and external customers.
• Interacts closely with Excellos departments and external partners to ensure efficient, compliant, and timely execution of project activities.
• Understands and adheres to the policies and standards as developed as part of the Excello Lab Quality.
• Participates as a team member and is accountable for own work responsibilities.
• Participates in departmental meetings and attend other meetings as assigned.
• Maintain inventory levels of raw materials, components, and supplies as required to support EM of the Cleanroom/production.
• Coordinates and manages all cleaning supplies and gowning re-stocking points with supply chain to support CT Cleanrooms.
• Performs other related duties as assigned or requested.

WORKING ENVIRONMENT

• Normal office environment.
• Cleanroom environment requires gowning in the form of scrubs, cleanroom gowns, hoods, gloves, sleeves, boot covers, and face masks.
• May be required to work a flexible shift structure to meet needs of the department.
• No makeup or jewelry can be worn when working in a cleanroom environment.

PHYSICAL REQUIREMENTS

• Must be able to stand in a cleanroom for prolonged periods of time
• Must be able to successfully gown to ISO7 standards for Cell Therapy (gowning in the form of scrubs, cleanroom gowns, hoods, gloves, sleeves, boot covers, and face masks)
• May be subject to prolonged sitting, reaching horizontally.
• Must be able to work on a computer 4 - 8 hours a day.
• Must have ability to move around office
• Must have ability to lift up to 30 pounds.

EQUIPMENT USED

• Standard office equipment such as computers, telephones, copy machines, fax machines and scanners.
• EM and laboratory equipment.

QUALIFICATIONS

Education:

• Associate Degree, or a combination of work experience and college coursework in the sciences required.

Experience:

• Minimum of two years of relevant experience in a pharmaceutical, biotechnology, or cell therapy manufacturing facility preferred.
• Experience with laboratory and aseptic manufacturing techniques.
• Cleanroom and GMP experience.

Skills:

• Good organizational and time management skills; must be able to establish priorities and self-organize tasks.
• Ability to perform accurate detail-oriented work.
• Must possess good verbal and written communication skills.
• Ability to trend and analyze data.
• Ability to perform tasks per cGMP regulations including following detailed SOPs, maintaining training, deviation reporting and good documentation practices.
• Proven ability to meet deadlines, including time-sensitive tasks.
• Ability to use effective problem-solving techniques and make sound decisions.
• Ability to maintain confidentiality.
• Ability to work well with others.
• Ability to perform environment monitoring testing in a highly accurate and reproducible manner.
• Strong working knowledge of Microsoft Suite applications, including Word, PowerPoint and Excel.

This position is on site in San Diego, CA.

Shift: Monday - Friday 8:00am - 5pm

Salary range: Range $24 - $28 per hour