Manager/Sr. Manager, MSAT

Senti Biosciences

Senti Biosciences

South San Francisco, CA, USA
Posted on Saturday, June 22, 2024
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.


  • 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


  • 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