Senior Scientist Analytical Science & Technology
Overview
Lead method transfers and validations for external CDMO at Cambridge, MA hybrid-remote role. Drive assay development and quality compliance for cell therapy innovations in ophthalmology. Unique opportunity to shape analytical science at a growth-focused biotech.
What You'll Do10
- 1Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
- 2Review outsourced GMP work and serve as Lead SME for method validations assay control establishment and bridging/USP equivalency testing
- 3Build tools to monitor assay validity and maintain them
- 4Assess assay validity and investigate challenges independently
- 5Interface with external stakeholders and internal teams including Analytical Development CMC and Quality Assurance
- 6Resolve technical issues and escalate challenges to management with constructive proposals
- 7Ensure compliance within QC by monitoring test methods SOPs and analytical data to cGMP pharmacopeial and regulatory requirements
- 8Provide technical support for deviations laboratory investigations and evaluate analytical change requests
- 9Authoring and reviewing protocols reviewing raw data and authoring reports
- 10Maintain flexibility as phase appropriate
Requirements12
- 15+ years building ETL pipelines with Spark and Airflow
- 2Master’s Degree in Chemistry or related field
- 3Experience with method validations and USP method verification in late-stage clinical development
- 4Excellent working knowledge of cGMP requirements pharmacopeial and relevant guidelines EMA FDA ICH
- 5Hands-on experience with Flow Cytometry
- 6Statistical analysis software proficiency JMP preferred
- 7Ability to identify risks associated with method qualifications and validations
- 8Proven expertise in analytical method lifecycle management including test method approval verification validation and transfer
- 9Required skill: Interface with CDMOs
- 10Strong collaboration abilities across organizational levels
- 11Demonstrated proficiency in project delivery
- 12Advanced written and verbal communication skills
Salary Insight
$140 - $155k per year
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
RD Partners
VerifiedTechnical Development Principal Scientist R&D Partners
R&D Partners seeks a Technical Development Principal Scientist in San Diego to lead analytical method development for cell therapy product release. You will design and execute studies using DoE to develop or adapt analytical methods. This role involves leading experiments, analyzing data, and collaborating with junior staff to ensure high-quality results. It requires expertise in flow cytometry and immunology with proven leadership in method optimization and CMC tech-transfer.
Aspect Biosystems
VerifiedScientist Quality Control Analytical Development Aspect Biosystems
Scientist leading end-to-end development of cell-based analytical methods for bioprinted tissue therapeutics in Fremont California. This role focuses on establishing robust analytical methods while partnering with QC Process Development and Research to achieve clinical readiness. The position requires expertise in precision scalable assays and regulatory compliance.
Legend Biotech US
VerifiedScientist I Analytical Development
Scientist I leads Functional Flow Cytometry and BioAnalytics team to establish and develop analytical methods for cell and gene therapy pipeline. This laboratory-focused role requires developing, optimizing, and qualifying methods for viral vector and CAR-T product characterization. Candidate will author and review methods, maintain electronic lab notebooks, and collaborate across functional teams.
Tunnell Consulting
VerifiedCell Therapy Analytics Specialist - Boston MA Contract
Contract Cell Therapy Analytics Specialist leading analytical method qualification and validation for biotech clients in Boston. This 3 month role requires 40 hours weekly onsite work. Candidates must demonstrate expertise in cell therapy analytics and deliver results for late-stage clinical development and BLA submissions.
Denali Therapeutics Inc
VerifiedPrincipal Scientist CMC Analytical Development - Commercial Products
Denali Therapeutics seeks a Principal Scientist to lead analytical development for commercial manufacturing and QC. This scientist will own analytical lifecycle for a newly launched product while expanding responsibilities across additional programs. The role requires technical expertise in analytical chemistry and regulatory compliance to ensure seamless transition to commercial production and global market entry.
1010 Gilead Sciences, Inc.
VerifiedPrincipal Scientist Analytical Lifecycle Management
Lead Quality Control for late-stage biologics programs at Gilead, driving integrated QC strategies across CMC teams. Own analytical control strategy from method establishment to commercialization readiness. Differentiate by leveraging deep regulatory expertise and cross-functional leadership.