Director, Analytical Development
$200,000–$226,000 year
HybridLexington, Massachusetts, United States
Lexington, Massachusetts, United StatesHybridPart Time$200,000–$226,000 yearSenior LevelSmall
Part TimeSenior LevelSmall
Job Summary
Lead analytical development strategy for early to late-stage biologics programs, developing structural, physical, and advanced protein characterization methods for fusion proteins and mAbs from preclinical through commercial launch. Serve as subject-matter expert in protein characterization and stability, partnering with Manufacturing, Process Development, and Quality to define phase-appropriate analytical methods, specifications, and control strategies. Advise and oversee CDMOs and external laboratories on method development, transfer, and validation, ensuring data quality, compliance, and regulatory readiness for IND amendments and BLA/MAA filings. Provide laboratory-based analytical support to upstream and downstream process development and mentor a team of scientists and analysts.
Required Qualifications
- Lead analytical development strategy for early to late-stage biologics programs, including Pre-Clinical, Phase I and Phase II/III
- Develop the strategic implementation of increasing levels of structural, physical, and advanced protein characterization in phase appropriate manner
- Serve as the subject-matter expert in protein characterization and stability for phase-appropriate development of the pipeline
- Partner with Manufacturing, Process Development, and Quality teams to define and implement phase-appropriate analytical methods, specifications, and control strategies to support DS and DP
- Advise and oversee CDMOs' analytical method development, transfer, and validation
- Collaborate with CDMOs and CROs to develop and optimize a range of analytical assays for the release and characterization on a series of fusion protein and mAb biologics at each stage from preclinical to commercial launch
- Provide oversight of CDMOs and external testing laboratories, ensuring timelines, data quality, and compliance
- Ensure analytical methods and specifications are scientifically justified, phase appropriate, and compliant with applicable compendial standards and regulatory guidelines
- Support comparability, stability, and characterization strategies for process changes and scale-up
- Provide and develop laboratory based analytical support to upstream and downstream process development to drive new and improved processes for DS production
- Provide leadership and mentorship to a team of scientists and analysts
- Support cross-functional team coordinating efforts of the Technical Operations, Quality, and Regulatory to advance programs
- Drive analytical support for regulatory submissions, including IND amendments, BLA/MAA filings, and responses to health authority questions
- Author Analytical CMC sections of IND filings, internal SOPs, experimental procedures, training and safety documents
- Experience with biologics analytical support in late-stage activities (Phase 3 and commercialization)
- Strong background in protein characterization, analytical method development, qualification/validation, and physicochemical characterization of fusion proteins and protein therapeutics
- Deep understanding of analytical methods and data interpretation to evaluate protein structure, post translational modifications, and characterization
- Experience supporting transitions from discovery through IND-enabling or early clinical development
- MS with 10+ years or PhD with 7+ years in molecular/cellular/structural biology, biochemistry, or a related field
- Proficiency with biochemical and biophysical methods: CE (CSDS, CIEF and CGE DNA), qPCR, potency, MFI/HIAC, DSF, DLS, DSC, and LCMS/MS peptide mapping & subunit analysis
- Proficiency with Chromatography: IA, SEC, RP, HIC and IEX
- Proficiency with Glycosylation: monosaccharide, sialic acid characterization and N-linked Glycan analysis
- Proficiency with Spectroscopy: UV/Vis, luminescence
- Experience in biochemistry techniques such as protein expression, gel electrophoresis, protein quantification assays, ELISA, cell-based assays, and enzyme kinetics
- Understanding of molecular biology, recombinant protein expression and construct design for affinity purification methods
- Experience in purifying proteins through recombinant processes
- Excellent collaboration skills and ability to work cross functionally to achieve objectives
- Strong work ethic, motivation, and scientific curiosity
Desired Qualifications
- familiarity with standard expression hosts such as mammalian, is a plus
- Experience in purifying proteins through recombinant processes is a plus
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.