Description
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 deeply motivated process science leader with strong technical skills in Cell & Gene Technologies to build from the ground up MSAT team that will provide critical leadership in all stages of CMC lifecycle in a rapidly growing pipeline of innovative gene-editing therapeutics. In this essential new function overseeing Manufacturing Sciences of gene modified cellular therapies, you will be responsible for operationally-focused technical leadership with key responsibilities in process validation, technology transfer, process monitoring, deviation management and change management; with initial manufacturing oversight and support of new manufacturing facility commissioning and qualification.
Responsibilities:- Ensure MSAT activities are prioritized and executed to meet commitments on-time, in full and with optimal project delivery; ensure the financial performances of MSAT by monitoring and driving decisions that have positive impact on the financial results as reflected by cashflow, standard costs, and production efficiencies
- 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
- Lead 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
Requirements: - Ensure MSAT activities are prioritized and executed to meet commitments on-time, in full and with optimal project delivery; ensure the financial performances of MSAT by monitoring and driving decisions that have positive impact on the financial results as reflected by cashflow, standard costs, and production efficiencies
- 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
- Lead 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
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.
