Principle Quality Control Analyst, Analytical

Alameda, CA /
Technical Operations Alameda /
Full-Time
/ On-site
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.

Summary:
This position is responsible for leading and acting as SME in Quality Control bioanalytical testing for in-process, release, and stability testing of clinical cell therapy drug products.  Additionally, the Principle QC Analyst owns and leads QC investigations and continuous improvement efforts along with managing junior QC analysts to support projects.

Responsibilities:

    • Manage bioanalytical testing and data review of in-process, batch release, and stability samples of cell therapy drug product in accordance with applicable procedures and cGMP requirements.
    • Ensure timely completion of testing and tasks as assigned.
    • Review, trend and report data obtained from product testing.
    • Lead the processes of method transfer and method qualification/validation.
    • Perform or manage on additional test methods and provide support to a broader spectrum of testing responsibilities.
    • Lead investigations through data gathering or interview process for root cause analysis and product impact.
    • Apply scientific principles to analytical testing and the proper use of laboratory equipment.
    • Author and revise analytical SOPs, protocols, reports.
    • Communicate effectively with management regarding task assignment and completion, roadblocks, and needs.
    • Lead in projects and continuous improvement efforts.
    • Manage junior analysts work assignments and performances.
    • Support management in QC matters: budget, lab supports, timeline, training.
    • Perform other tasks as assigned.
    • Support for QC and manufacturing operations requires shift coverage consisting of weekdays, weekends, holidays, and during adverse weather conditions.

    • BS or MS degree in chemistry, biology, or related disciplines with at least 7 years of experience in GMP required.
    • Must have experience with Aseptic Techniques and mammalian cell culture.
    • Experience with molecular and cell based assays include Flow Cytometry, qPCR, digital PCR, cytotoxicity assays, ELISA/Luminex assays and cell counting.
    • Must have GMP experience.
    • Must have experience in quality technical writing (SOP, reports, regulatory filings, etc.)
    • Experience in managing small QC group (optional).
    • Must be meticulous, detail oriented, and analytical.
    • Must be highly motivated, have excellent organizational, communication and interpersonal skills.
    • Must be able to work independently and as part of a multi-disciplinary team.

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 publicly traded (Nasdaq: SNTI) gene circuit company headquartered in South San Francisco. Our mission is to create a new generation of smarter medicines that outmaneuver complex diseases using novel and unprecedented approaches.

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.