Senti Bio is currently recruiting for an Associate Director of Quality Control, reporting to the Head of Quality. This role will be the primary point of contact and SME for all Senti QC topics including but not limited to analytical method transfer, method qualification and validation, oversight of external testing at Contract Manufacturing facilities and Contract Test Labs (CTLs), continuous improvement of QC programs, management of stability studies, setting of product specifications, data analysis and trending, authoring and review of QC-related documents for regulatory submission, and reporting of metrics to senior leadership, all supporting development of Senti’s cutting edge cell therapy and gene circuit technology.
The ideal candidate brings broad QC experience in early- and late-phase clinical environment, Cell Therapy experience, excellent communication skills, a collaborative can-do mindset, and an agile hands-on approach.
Responsibilities
Establish phase-appropriate QC programs and write QC procedures, ensuring alignment with regulatory expectations
Represent QC and Senti Quality in internal and external activities
Oversee outsourced product release and stability testing, manage data generated by contract test labs
Lead stability programs including driving stability strategy, writing protocols, reports, data management and trending
Collaborate effectively with the internal Analytical Development team and external manufacturing partners and CTLs to support testing, troubleshooting, method transfer, method qualification, and investigations of OOT/OOS, deviations
Lead method validation strategy and support CDMOs through method validation execution and reporting
Support lot disposition activities as needed, including test record review, review of QC-relevant investigations, etc
Participate in setting and revision of product and specifications
Author and review IND-associated documentation including technical source documents
Establish and maintain systems for QC data archiving and retention
Present QC metrics and data trend analysis to Quality Management Review
Qualifications
Bachelor's degree in life science or related discipline
At least 8+ years of Quality Control experience in biologic therapeutics including products in clinical development
Method transfer, qualification, and validation experience
Experience with early clinical stage cell/gene therapy programs preferred
Excellent verbal and written communication skills
Employ a risk-based and data driven approach to compliance
Strong interpersonal skills; able to deal effectively with a variety of internal and external personnel.
Salary and Benefits
Compensation for this role includes base salary, annual target bonus and equity
The base salary range for this role is $180,000-$200,000. 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