Quality Control Manager

Job Description

Job Description

JOB SUMMARY

Quality Control Manager will lead the QC Lab startup and implementation, and then oversee and manage ongoing QC testing for Excellos.

The QC Manager role requires cGMP implementation of specialized customer testing, developing relevant SOPs, contributions to assay and equipment validations, and continuous improvement of systems to support a growing company.

RESPONSIBILITIES

• Supervise personnel to execute cGMP testing.
• Development, validation, and implementation of novel testing methods.
• Provide leadership, guidance, training, and direction to staff in alignment with cGMP requirements.
• Collaborates with area managers to ensure accuracy and adherence to production schedules.
• Set daily work activities and roles for staff to meet production demands.
• Coordinate internal product testing and sample submission to contract laboratories.
• Proactively identifies and assesses operational risks, communicates issues to senior management and cross-functional support teams.
• Extensive experience in Cell Therapy QC testing Laboratories.
• Comprehensive knowledge of current Good Manufacturing Practices (cGMP).
• Proficiency in flow cytometry, cell counting and potency methods.
• Authoring, revising, and reviewing of analytical methods, sampling plans, SOPs, and on the job-training documents.
• Data analysis, review and approval of QC assays and contract lab testing documentation
• Generation of Certificates of Analysis.
• Administration and oversight of stability testing programs.
• Experienced in troubleshooting, investigation, and root cause analysis in a cGMP environment.
• Interface with clients and regulators.
• Participates in hiring and training, and / or corrective action of direct reports.
• Participates in department meetings and educational programs.

WORKING ENVIRONMENT

• Must work with living human cells and various chemicals.
• May be exposed to blood or bodily fluids that may be capable of transmitting diseases.
• Frequent exposure to outdoor environment and non-company facilities.

PHYSICAL REQUIREMENTS

• Must be able to work on a computer up to 4-8 hours per day.
• Must be able to operate laboratory equipment.
• Must be able to stand for prolonged periods of time.
• Must be able to communicate clearly.
• Must be able to attend meetings outside of office.
• May be required to lift up to 40 pounds.
• May be required to accommodate repetitive motion such as pipetting.
• Must be able to gown into a ISO7 cleanroom.

EQUIPMENT USED

• General Laboratory equipment (examples : flow cytometer, cell counters, Biological Safety cabinets, plate readers).
• Normal office equipment (examples : telephone, computer, cell phone, copier).

QUALIFICATIONS

Education :

Bachelor of Science in related field or equivalent combination of education, training, and / or experience.

Experience :

• 5-7+ years of bio-industry experience with a minimum of 5 years of experience in a cGMP Quality Control Laboratory.
• 3+ years of management experience.
• Strong understanding of QC testing methods and processes, compliance, sterility, and cell therapy.
• Knowledge of cell therapy collection, processing and laboratory equipment and supplies.
• Prior CDMO experience a plus.
• Knowledge of microbiological testing methods and processes, experience in this testing a plus.
• Ability to perform testing with little or no supervision.

Certifications / Licenses :

Biotechnology or similar certificate preferred.

Skills :

• Interpersonal skills to establish and maintain professional relationships.
• Detail oriented team player with effective planning, organization and execution skills.
• Good organization and time management skills.
• Ability to work in a high paced team environment.
• Decision-making skills. Uses authority appropriately in making sound judgments in a timely manner. Accepts accountability.
• Flexibility - ability to effectively manage change and positively influence others.
• Integrity and discretion ability to maintain confidentiality.

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.

Monday - Friday and occasional Saturdays.

Must be onsite at our facility in Downtown San Diego.

40 hours per week.