Senti Biosciences Inc. South San Francisco , CA 94080
Posted 1 week ago
We are seeking an experienced 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
Provide support for deviation investigations, development of CAPAs and change controls
Troubleshoot activities for the production processes with the objective to guarantee that the product is delivered in time, and meets quality standards
Identify continuous improvement opportunities through manufacturing process monitoring and trending
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
Salary and Benefits
Compensation for this role includes base salary, annual target bonus and equity
The base salary range for this role is $140,000-$171,000. Starting pay is determined by multiple job-related factors including a candidate's skills, education and experience level, benchmark, and internal parity
Significant growth opportunity as the company expands
Empathetic, supportive and collaborative colleagues and work environments
Senti Biosciences Inc.