Manager/Sr. Manager, QC Analytical (Cell & Gene Therapy)

Summary :

We are looking for a Manager or Sr. Manager, Quality Control Analytical responsible for managing the Quality Control Analytical team and testing to support GMP Cell and Gene Therapy Manufacturing for a CDMO.

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.

Location :

San Francisco, Bay Area : Alameda, CA (on-site position)

Enigma Search Solutions is an equal opportunity employer. We value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform critical job functions, and to receive other benefits and privileges of employment.