Director, Quality Control at Senti Biosciences
Alameda, CA, US
Thank you for your interest in a career at Senti Biosciences. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases in ways previously inconceivable. We are passionate about designing gene circuits to improve the “intelligence” of cell and gene therapies in order to enhance their therapeutic effectiveness against a broad range of diseases that conventional medicines are unable to address.
 
At Senti, we find purpose and meaning knowing that our efforts have the potential to improve the lives of patients and their families with more effective and safer treatment options. With science as our foundation and empathy as our key guiding principle, colleagues become friends, managers become mentors, and with time, cancer becomes history.
 
We are seeking a highly motivated collaborative Director of Quality Control to build out and manage Analytical and Microbiology QC GMP laboratories, oversee technology transfer, qualification/validation of assays and QC activities for product release of Senti’s cell/gene therapies.

Responsibilities:

    • Implement & Manage the CGMP Quality Control lab operation, establishing analytical and microbiological labs and procedures. Work with internal and external vendors ensuring proper set-up and qualification of equipment and electronic management system. Set up QC lab procedures for material and sample management, routine testing, general lab practices, and equipment calibration and maintenance. Define testing analysis, review, reporting, OOS, and investigation procedures
    • Determine Environmental monitoring strategy and build EM program and procedures
    • Support analytical method transfers and qualifications. Build method lifecycle management program and data trending analysis
    • Collaborate with analytical and process development teams to establish core analytical testing capabilities for cell & gene therapy products
    • Work with analytical and process development teams to transfer biological and molecular assays between internal and external laboratories, monitor and troubleshoot process and method performance
    • Serve as a subject matter expert on the phase appropriate validation of non compendial test methods and/or qualification of compendial methods for clinical products intended for early to late stage clinical trials
    • Setup and manage testing for manufacturing process characterization and validation, product QC testing, stability testing, QC Microbiology and execution of cGMP lab operations
    • Ensure lab processes provide high quality analytical support for manufacturing, maintenance, engineering, and validation operations while ensuring compliance with protocols, GMP's, and safety regulations
    • Develop, author, review, and/or approve Standard Operating Procedures, specifications, Certificate of Analysis, regulatory filing, or other controlled documents as needed
    • Recruit, hire, and build a collaborative and high performing QC team
    • Implement and adhere to internal and external (ICH, GMP) requirements for analytical functions, including training, investigations, validation, and QC testing
    • Work within the Quality team and interface with key stakeholders to establish and maintain CGMP compliant quality control operations
    • Provide strong leadership to ensure CGMP compliance is built into the implementation of processes and systems, including but not limited to tracking metrics (KPI) to monitor and improve performance

Qualifications:

    • BS/MS degree, in life science degree specially general biology, microbiology, virology, immunology, and a minimum of 10 years of relevant experience in the biopharmaceutical industry, including 5 years of leadership experience, and demonstrated strong expertise in operational CGMP
    • Experience with QC micro (EM, bioburden, endotoxin, growth promotion), media fill, aseptic  and gowning qualification highly desirable
    • Experience with analytical development and 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
    • Experience with Business Process Management, and Operational Excellence toolset(s) such as Toyota Way, Lean, and Six Sigma, within the BPM framework is desirable
    • 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
    • Demonstrated ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality Control and outside of the function
    • Be a decisive decision maker and problem solver to support timely result delivery and customer satisfaction
    • Self-motivated and passionate about advancing the field of cell therapies
    • Self-awareness, integrity, authenticity, and a growth mindset

Salary and Benefits:

    • Base pay and stock options to be determined based on application qualifications with the aim of being competitive with similar roles in the area
    • Significant growth opportunity as the company expands
    • Empathetic, supportive and collaborative colleagues and work environment
Senti Bio is a leading gene circuit company designing gene circuits to create a new generation of “smarter medicines" and enhance the therapeutic effectiveness of cell and gene therapies against a broad range of diseases that are unaddressed by current standards of care. We are proud to count Leaps by Bayer, NEA, 8VC, Matrix Partners China, Mirae Asset Capital, Amgen Ventures, Intel Capital, Ridgeback Capital, Lux Capital, KB Investment, Pear VC, Smilegate Investment, Menlo Ventures, LifeSci Venture Partners, Alexandria Venture Investments, Allen & Company, LifeForce Capital, Omega Funds, Nest.Bio, Gaingels, Noveus Capital, and Goodman Capital among our investors. Senti Bio is based in South San Francisco, CA, USA.