Associate Director, Analytical Development (T cell engager) 

Position Summary

The Associate Director, Analytical Development will play a key role in advancing analytical CMC activities for the T-cell engager programs from early preclinical through IND-enabling and ultimately into clinical development. Based in our New York City headquarters (potential for remote or hybrid work for strong candidate), this individual will provide technical expertise, leadership and oversight of analytical activities, including method development, qualification, validation, and lifecycle management.
Reporting to senior analytical leadership, the role will coordinate analytical strategy and execution through internal teams, external laboratory and CRO partners to ensure high-quality, compliant deliverables that support regulatory submissions, GMP clinical manufacturing, and pharmacology assessments.
This position is designed for a strong technical leader who can operate both strategically and hands-on, and offers significant opportunity to advance as the organization continues to expand.

Key Responsibilities

Core Analytical Responsibilities
· Lead analytical method development, qualification, validation, and transfer for T-cell engager biologics. (May be in collaboration with CRO or laboratory partner)
· Implement phase-appropriate analytical control strategies aligned with program and regulatory expectations.
· Provide expertise in assays assessing identity, purity, potency, safety, stability, and characterization.
· Review and interpret complex analytical data to support TCE product understanding, comparability studies, and specification setting.
· Manage reference standards and control materials.
· Provide technical guidance in protein characterization and cell-based potency assays, including:
o SEC, CE-SDS, icIEF, HIC, RP-HPLC
o Binding assays (SPR, BLI, ELISA)
o Cell-based potency assays (T-cell activation, cytotoxicity, reporter assays)
o Aggregation, fragmentation, and impurity profiling
o Stability-indicating methodologies
· Oversee pre-clinical animal studies such as toxicity and bioequivalencestudies (PK, ADA, biomarkers) in alignment with ICH M10 guidelines.
· Support analytical strategy for process changes, scale-up activities, and comparability assessments.

CRO Oversight
· Assist with CRO evaluation and selection
· Serve as the analytical lead for contract laboratories and external partners.
· Review and approve protocols, technical reports, validation documents, and investigation summaries (including OOS/OOT).
· Monitor timelines, deliverables, and technical performance of CROs to ensure project milestones are met.
· Ensure data integrity and inspection readiness of externally executed analytical programs.

Cross-Functional & Compliance Responsibilities
· Partner with Process Development, Manufacturing, Clinical, Quality, and Regulatory teams to support CMC sections of regulatory submissions.
· Lead analytical investigations and root-cause analyses.
· Ensure all activities comply with ICH Q2(R2), Q6B, Q14, and cGMP requirements.
· Review SOPs, change controls, and maintain strong documentation practices to support inspections .

Qualifications

Education & Experience
· PhD with 5+ years, MS with 8+ years, or BS with 10+ years of industry experience in analytical development.
· Experience with bispecific or T-cell engager molecules.
· Experience developing and managing cell-based potency assays is preferred.
· Experience managing or coordinating analytical activities at CROs or external laboratories.
· Experience generating publication quality data for presentation at conference, meetings and data submission
· Experience supporting regulatory submissions is a plus.

Technical Skills
· Strong understanding of protein characterization and structure-function analytics.
· Understanding of regulatory expectations for method validation, transfer, and comparability.
· Experience with specification setting, comparability, and stability programs.

Leadership & Personal Attributes
· Strong organizational and project management skills with the ability to manage multiple programs simultaneously.
· Excellent written and verbal communication skills for presenting complex data.
· Comfortable working in a dynamic, early-stage biotech environment that requires both strategic thinking and tactical execution.
· Self-motivated, detail-oriented, and highly collaborative.

To apply, email your resume and cover letter to hr@in8bio.com