Executive Director, Analytical Sciences

Overview of Role:

The Executive Director, Analytical Sciences will provide strategic and operational leadership for all analytical activities supporting the development, registration, and commercialization of the Company’s lead bispecific antibody product. With the first Biologics License Application (BLA) already submitted, this role is critical to ensuring regulatory compliance, product control, and lifecycle readiness as the organization transitions from late-stage development into commercial supply.

The successful candidate will be accountable for the end-to-end analytical control strategy, including method development, qualification, transfer, and oversight of GMP release and stability testing executed through a virtual network of CDMOs and partner laboratories. This individual will act as a key CMC leader and regulatory partner, interfacing closely with Quality, Manufacturing, Regulatory Affairs, and external collaborators.

Role and Responsibilities:

Analytical Strategy & Product Control

• Own and continuously evolve the global analytical control strategy for clinical and commercial drug substance and drug product.
• Ensure analytical readiness to support BLA review, responses to regulatory questions, inspections, and post-approval commitments.
• Define analytical lifecycle management strategies aligned with ICH Q2/Q6/Q12 and global regulatory expectations.

Method Development, Qualification & Transfer

• Provide oversight and scientific leadership for:
• Method development and optimization
• Method qualification and validation
• Method transfer to internal and external laboratories
• Ensure analytical methods are phase-appropriate, robust, stability-indicating, and fit for commercial use.
• Troubleshoot complex analytical issues related to bispecific antibodies (e.g., heterogeneity, potency, binding, impurities).

GMP Release & Stability Oversight

• Accountable for all drug substance and drug product release and stability testing conducted at external CDMOs and partner labs.
• Ensure compliance with cGMP, data integrity, and regulatory filing requirements.
• Review and approve analytical protocols, reports, deviations, OOS/OOT investigations, and change controls.

CDMO & Partner Management

• Lead analytical governance across a virtual network of CDMOs, contract labs, and development partners.
• Set expectations, KPIs, and quality standards for external analytical execution.
• Serve as the primary analytical escalation point for CDMO performance, compliance, and technical issues.

Regulatory Support

• Act as the analytical subject-matter expert for global regulatory interactions.
• Author, review, and approve analytical sections of:
• BLAs, MAAs, and IND/IMPD amendments
• Regulatory responses and briefing packages
• Support regulatory inspections, audits, and health authority meetings.

Cross-Functional Leadership

• Partner closely with Process Development, Manufacturing, Quality, Regulatory Affairs, and Supply Chain.
• Contribute to overall CMC strategy, risk management, and commercialization planning.
• Build scalable analytical capabilities aligned with future pipeline expansion.

Experience, Education and Specialized Knowledge and Skills:

• PhD in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field

(MS with extensive relevant experience considered)

Experience

• 15+ years of progressive experience in analytical sciences within the biopharmaceutical industry

• Demonstrated leadership in late-stage development and commercial biologics
• Direct experience supporting BLA/MAA submissions and approvals
• Strong expertise in monoclonal and/or bispecific antibodies
• Proven success operating within virtual or highly outsourced CMC models

Technical Expertise

• Deep knowledge of:
• Physicochemical and functional characterization of biologics
• Potency, binding, and cell-based assays
• Stability programs and comparability strategies
• Strong understanding of GMP, ICH, FDA, EMA, and global regulatory requirements
• Experience managing analytical aspects of process changes, scale-up, and post-approval lifecycle management

Leadership & Competencies

• Strategic thinker with a commercial mindset
• Comfortable operating in ambiguity and fast-paced, resource-lean environments
• Strong external partner and stakeholder management skills
• Excellent written and verbal communication, including regulatory writing
• Hands-on leader capable of balancing strategic oversight with technical depth