The
Manager or Sr. Manager, Quality Control Analytical
is responsible for managing the Quality Control Analytical team and testing to support GMP Cell and Gene Therapy Manufacturing. This includes release testing, in-process testing, stability testing, method transfers and other general Quality Control tasks such as qualification and validation of new assays.
Responsibilities:
Provides operational and technical leadership to the QC Analytical through management, planning and allocation of resources.
Optimize QC lab procedures for material and sample management, routine testing, general lab practices to increase accuracy of testing and turnaround time.
Ensure all tests are performed as per the clients' expectations and interact with them to provide test results and recommendations.
Lead OOS, and investigation procedures.
Maintain Laboratory equipment and work areas in good working condition.
Collaborate with Analytical Science and Technology team to transfer biological and molecular assays between internal laboratories and clients, monitor and troubleshoot process and method performance.
Develop, author, review, and/or approve Standard Operating Procedures, specifications, Certificate of Analysis, regulatory filing, or other controlled documents as needed.
Implement and adhere to internal and external (ICH, GMP) requirements for analytical functions, including training, investigations, validation, and QC testing.
Manage the QC Analytical staff relating to performance management; coach and mentor staff to facilitate their personal and professional growth.
Prepare and respond to internal and external audits.
May perform other duties as assigned.
Qualifications:
BS degree in Life Sciences or related field with 7-10 years of technical lab experience and at least 5 years of managerial experience
Experience in a GMP operation is required.
Experience with QC of Cell and Gene Therapy products; hands on flow cytometry, cell-based assays and qPCR experience highly desirable.
Demonstrated leadership with strong communication skills (both verbal and technical) and committed to establishing a QC culture to support collaboration and advocating for continuous improvement.
In-depth knowledge of QC principles, concepts, industry practices, and standards.
Keen understanding of international quality control systems regulations to adopt best in class systems/processes and drive continuous improvement initiatives.
Self-motivated and passionate about advancing the field of cell therapies.
Self-awareness, integrity, authenticity, and a growth mindset
Salary and Benefits:
The base salary range for this role is $133, 550.00
- $163, 228.00 ; starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity.
We offer an excellent benefits program including a selection of Medical, Dental and Vision plans, FSA, HSA, Company paid holidays, employee assistance program, commuter benefits, wellbeing resources, perks and more!
Significant growth opportunity as the company expands.
$133,550 - $163,228 a year
About GeneFab
GeneFab is a contract manufacturing and synthetic biology biofoundry focused on cell and gene therapies. GeneFab was formed in 2023 with a vision to combine industry leading expertise in synthetic biology with advanced cGMP capabilities in order to accelerate the development and commercialization of genetic medicines. GeneFab offers its customers an extensive technology platform and know-how that spans early stage product design, technical development, and cGMP compliant production. GeneFab's technology platform includes bioinformatic-guided discovery of cell type promoters, directed evolution of small molecule-regulated gene switches, and the engineering of highly sensitive kill switches for enhanced safety and control of cellular therapies.
We are committed to an inclusive and diverse GeneFab. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse GeneFab team. We welcome people of different backgrounds, experiences, abilities, and perspectives and are an equal opportunity employer.
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