Manager, Quality Control Analytical 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 Manager that will lead the QC Analytical group. Working in a collaborative, cross-functional team environment, this position 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, tech transfers and other general Quality Control tasks such as qualification and validation of new assays.

Responsibilities

    • Manage the CGMP Quality Control lab, establishing analytical procedures.
    • Set up QC lab procedures for material and sample management, routine testing, general lab practices, and equipment calibration and maintenance.
    • Perform testing analysis, review, reporting, OOS, and investigation procedures.
    • Support analytical method transfers and qualifications.
    • Maintain Laboratory equipment and work areas in good working condition.
    • 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.
    • Manage testing for manufacturing process characterization and validation, product QC testing, stability testing, and execution of cGMP lab operations.
    • 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.
    • May perform other duties as assigned.

Qualifications

    • BS/MS degree, in life science: general biology, microbiology, virology, immunology, and 3-5 years of relevant experience in the biopharmaceutical industry, and demonstrated strong expertise in operational cGMP.
    • 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

    • 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, and others among our investors. In December 2021, Senti Bio and Dynamics Special Purpose Corp. (Nasdaq: DYNS), a special purpose acquisition company (SPAC), announced a definitive business combination agreement to create a public company focused on Gene Circuit-engineered cell and gene therapies. The transaction is expected to be completed in the second quarter of 2022. Senti Bio is based in South San Francisco, CA, USA.
 
We are committed to an inclusive and diverse Senti Bio. We believe that different perspectives lead to better ideas, and better ideas allow us to better understand the needs and interests of our diverse Senti Team. We welcome people of different backgrounds, experiences, abilities and perspectives and are an equal opportunity employer.