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Manager, Quality Control, Microbiology and Sample Management
2 months ago
Overview
The Manager, Quality Control (QC) Microbiology, is responsible for oversight of day-to-day microbial QC operations at Iovance’s Cell Therapy Center (iCTC). The role will be responsible for working in a GMP-regulated environment and having a good understanding of QC microbiology test methods and environmental monitoring. This role must be able to apply phase appropriate cGMPs and regulatory requirements in the product development life cycle, including but not limited to lot release and stability testing, method qualification and validation, method technology transfers, and writing/review of QC procedures. This role will also be responsible for ensuring time-sensitive distribution of quality control samples in support of QC-related microbiological testing activities. Microbiology functions are primary in this role, while Sample Management will be supportive.
This is a night shift position 11:00 pm to 7:30am
Essential Functions and Responsibilities
- Manage QC analysts at the iCTC in the day-to-day cGMP QC microbiological testing of in-process and drug product samples for lot release and stability.
- Lead investigations for LIR, out-of-specification test results.
- Perform CAPA and verification of effectiveness.
- Ensure timely sample distribution in support of Quality Control internal microbiological testing activities including sterility, endotoxin, Gram stain and mycoplasma rapid test method.
- Author, review, and approve SOPs, protocols, reports, specifications, and other quality control documents.
- Coordinate environmental monitoring non-routine sampling for the facility as needed.
- Support site contamination control programs.
- Support site qualification/validation/commissioning activities, as needed.
- Support career development of microbiology team members.
- Establish positive working relationships with internal and external partners, and implement processes for performance management, including routine meetings, onsite visits, performance monitoring, and issue notification.
- Support problem solving for technical issues pertaining to GMP quality control, working alongside technical SMEs as needed.
- Operate at a consistent and exemplary level of efficiency, producing high quality and accurate results, in a fast-paced environment.
- Maintain current knowledge base of regulations, corporate policies, and industry best practices, trends, and standards to ensure that the function remains in compliance with applicable requirements.
Required Education, Skills, and Knowledge
- Bachelor’s degree in a relevant discipline (biological sciences or equivalent).
- Minimum (8) years of experience in the biopharmaceutical industry within a Quality Control role.
- Minimum (3) years of experience managing a team.
- Broad knowledge of biological drug development with respect to Quality Control.
- Successfully interface with multi-disciplined teams in a global setting.
- Extremely detail-oriented with strong analytical, written, and verbal communication skills.
- Ability to effectively manage multiple priorities involving aggressive timelines at a high level of productivity.
- Demonstrate sense of urgency; ability to recognize time sensitivity.
- Flexible and adaptable style with an eagerness to take on challenges.
- Problem solver who not only identifies issues but leads efforts to resolve them.
Preferred Education, Skills, and Knowledge
- Experience with cell therapy product is a plus.
The physical demands described here represent those that an employee must meet to perform the essential functions of this job successfully. Reasonable accommodation may be made upon request to enable individuals to perform essential functions. Please contact Human Resources to request accommodation.
Physical Demands and Activities Required:
- Must be able to wear appropriate clean room attire and all Personal Protective Equipment (PPE), i.e. scrubs, gowning coverall, masks, gloves, etc.
- Able to stand and/or walk 90% (and sit 10%) of a 10-hr day which may include climbing ladders or steps.
- Must be able to use near vision to view samples at close range.
- Able to crouch, bend, twist, reach, and perform activities with repetitive motions.
- Must be able to lift and carry objects weighing 45 pounds.
Mental:
- Clear and conceptual thinking ability; excellent judgment, troubleshooting, problem-solving, analysis, and discretion; ability to handle work-related stress; ability to handle multiple priorities simultaneously; and ability to meet deadline.
Work Environment:
- This position will work in both an office and a QC lab setting.
- When in the lab, must be able to work in Lab setting with various chemical/biochemical exposures, including latex and bleach.
- Able to work in cleanroom with biohazards, human blood components, and
- Potential exposure to noise and equipment hazards and strong
The statements contained in this document are intended to describe the general nature and level of work being performed by a colleague assigned to this description. They are not intended to constitute a comprehensive list of functions, duties, or local variances. Management retains the discretion to add or to change the duties of the position at any time.
Iovance is committed to cultivating and offering a diverse and inclusive work environment. As an equal-opportunity employer, our employees and applicants will be considered without regard to an individual’s race, color, religion, sex, pregnancy, national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information, military and veteran status, and any other characteristic protected by applicable law. If you need assistance or accommodation to apply to one of our opportunities, please contact careers@iovance.com.
By voluntarily providing information and clicking “Submit Application”, you explicitly consent to the collection and use of your personal information for the purposes described above and in our Candidate Privacy Notice.
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