Associate Director Quality Control
Associate Director Quality Control
Posted on :
10-04-2025
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1 Vacancy
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Monthly Salary
$ 180000 - 200000
Vacancy
1 Vacancy
Posted on :
10-04-2025
Job Description
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 QCrelated documents for regulatory submission and reporting of metrics to senior leadership all supporting development of Sentis cutting edge cell therapy and gene circuit technology.
The ideal candidate brings broad QC experience in early and latephase clinical environment Cell Therapy experience excellent communication skills a collaborative cando mindset and an agile handson approach.
Responsibilities
- Establish phaseappropriate 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 and reporting
- Support lot disposition activities as needed including test record review review of QCrelevant investigations etc
- Participate in setting and revision of product and specifications
- Author and review INDassociated 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
- Bachelors 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 riskbased 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 $180000$200000. Starting pay is determined by multiple jobrelated factors including a candidates skills education and experience level benchmark and internal parity
- Significant growth opportunity as the company expands
- Empathetic supportive and collaborative colleagues and work environments
Required Experience:
Director
Employment Type
Full-Time
Key Skills
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