Scientist, MSAT (Process Engineer) at Senti Biosciences
South San Francisco, 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 Process Engineer to join our new Manufacturing Science and Technology group and contribute to the commercialization of allogeneic NK therapies. This individual will lead/support various aspects of technology transfer, validation, and manufacturing support activities. They will work closely with internal and external partners to ensure the development and execution of a master validation plan, and the subsequent execution of process performance qualification (PPQ) runs and continuous verification activities; change management; initial setup of manufacturing and support of new manufacturing facility commissioning and qualification.

Responsibilities

    • Collaborate with the Process Development team to ensure an appropriate process transfer with “facility fit” in mind, author and/or review Process Flow Diagrams, Bill of Materials, SOPs, Production Batch records
    • As product pipeline advances clinically, support process characterization, process comparability, process control, PPQ and PV activities
    • Provide guidance and applicable content for CMC regulatory submissions and ensure technical compliance with established conditions
    • Support technical interactions with regulators for health authority inspections and post-approval CMC changes
    • Lead/support Manufacturing Ops team to ensure safe, quality, and timely manufacture of products for pre-clinical, clinical and commercial use
    • Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards
    • Ensure that all tech transfers into manufacturing operations are controlled and executed within GMP regulatory guidelines and with appropriate training
    • Drive strategic operational resource and capacity planning
    • Collaborate with Quality colleagues to ensure high-quality product and timely resolution of Quality items: deviation management, change management and CAPAs
    • Partner effectively with counterparts at CDMOs and key suppliers to meet goals of reliable, robust manufacturability and high product quality including tech transfer and scale-up including process facility-fit assessments including Failure Modes and Effects Analysis (FMEA)- and Risk Assessments
    • Drive understanding of QbD approaches and implementation of creative problem solving

Qualifications

    • Bachelor's Degree in science or related discipline is required
    • 3+ years of MSAT biologics experience required, viral vector, cell and gene therapies experience highly desirable
    • Experience with technical support of clinical and commercial biological products and cGMP manufacturing
    • Extensive knowledge of US and EU cGMP regulations/guidance and experience with regulatory agency inspections desirable
    • Extensive experience with technology transfer, process validation and process monitoring
    • Direct experience working with contract manufacturing (CDMO) and/or technical service partners
    • Technical experience supporting manufacturing quality compliance including deviations, change controls and CAPAs
    •   Experience with developing CMC content and knowledge of regulatory guidance and trends
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.