QC Microbiology Lead
Legend Biotech CorporationLegend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
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Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
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Legend Biotech is seeking aĀ QC Microbiology Lead as part of the Quality team based in Raritan, NJ.
Role Overview
The QC Microbiology Lead is an exempt level position with responsibilities for supervising theĀ operation and workflow of the quality control microbiology laboratories in support of cell therapyĀ manufacturing. This includes hiring, development and performance management of staff,
reviewing/approving laboratory test data, developing and implementing microbiology procedures andĀ methods, supporting laboratory investigations and ownership of various QC microbiology departmentĀ projects.
Key Responsibilities
- Ensuring adequate training (skills-based, cGMP and safety) of associates within theĀ department.
- Raw material, in-process, environmental/utility, and product release testing.
- Scheduling of daily activities for personnel.
- Investigation of laboratory non-conformances (events, deviations, and invalid assays).
- Maintenance, calibration and qualification of laboratory instruments and equipment.
- Test method verification, qualification, validation and/or transfer activities in the QCĀ laboratories.
- Process Performance Qualification and Continued Process Verification activities associatedĀ with QC microbiology laboratory testing.
- Providing expertise in troubleshooting complex laboratory issues and demonstrating strongĀ reasoning skills in support of ongoing laboratory investigations.
- Maintain detailed knowledge of industry guidelines/trends, regulatory requirements, andĀ applicable pharmacopeia while remaining current in on-the-job training requirements.
- Collaborate with Quality Assurance, Manufacturing, Technical Operations, Engineering andĀ Maintenance to support business needs.
- Contribute to global strategies related to QC laboratories which align with compliance andĀ business objectives as well as the overall corporate vision.
- Manage departmental budget and resources; prepare staffing plans. Make adjustments toĀ roles and responsibilities of department to meet business needs.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- Works in a collaborative team setting with quality counterparts that include Quality Assurance,Ā Manufacturing Operations, Technical Operations, Engineering and Maintenance, Supply Chain andĀ Planning.
- Job duties performed routinely require exposure to and handling of biological materials andĀ hazardous chemicals
- Distance visual acuity of at least 20/30 (Snellen) in both eyes without corrective lenses or visualĀ acuity corrected to 20/30 (Snellen) or better with corrective lenses.
- Color Perception both eyes 5 slides out of 8.
Requirements
- A minimum of a Bachelor's Degree in Science, Engineering or equivalent technicalĀ discipline is required.
- A Minimum of 6 years relevant work experience is required. It is preferable that theĀ candidate have experience working in an aseptic manufacturing facility, preferably in quality control,Ā quality assurance, or cell therapy. A minimum of 1 year of leadership experience is also required.
- Experience in clinical quality, method development, cell banking, cell therapy, or Research &Ā Development is preferred.
- People management or leadership experience is required.
- Experience working with Quality systems is required.
- Experience with quality support in clinical manufacture or NPI is preferred .
- Extensive knowledge of chemical, biochemical and microbiological concepts is required .
- Ability to apply basic and advanced mathematical concepts (including statistics) in theĀ evaluation of laboratory data is required.
- Knowledge of cGMP regulations and FDA/EU guidance is required.
- The candidate must be highly organized and capable of working in a team environment with aĀ positive attitude under some supervision.
- Comfortable with speaking and interacting with inspectors.
- Good written and verbal communication skills are required.
- This position may require occasional travel to partner sites in NJ or PA as business demands.
- Candidates must be able to accommodate unplanned overtime (including nights andĀ weekends) on little to no prior notice.
- This position may require 10% domestic or international travel as business demands.
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The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws.
Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance. We also provide voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs; demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.
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EEO Statement
It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.
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Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.