Director Analytical Development

The Director Analytical Development, ADQC is a leadership position within Analytical Development and Quality Control (ADQC) department, responsible for providing strategic and technical leadership for analytical development activities supporting biologics programs from early phase to pivotal phase, BLA/MAA submission, and commercialization. This role will lead phase appropriate analytical control strategy, method development, qualification/validation, method transfer to internal and external laboratories, method lifecycle management, and ensure analytical readiness to support CMC milestones and regulatory submissions.

The incumbent will work closely with Quality Control, Quality Assurance, Process Development, Manufacturing, Regulatory Affairs, and external partners to establish robust scientifically sound, phase
-appropriate analytical strategies.

This is a highly visible leadership role requiring strong scientific judgement, hands-on laboratory expertise, and the ability to effectively develop junior staff and manage external partners in a highly regulated, fast-paced environment.

• Provide strategic and technical leadership for analytical development activities for biologics, including phase appropriate analytical control strategies, late stage/commercial assay reduction strategy, method development, validation, transfer to internal and external QC labs, and lifecycle management.
• Ensure analytical readiness for late‑stage development, PPQ, and commercial launch of SAB-142 polyclonal antibody program.
• Oversee and perform hands‑on analytical work at SAB’s development and GMP labs.
• Provide hands‑on and supervisory support to method troubleshooting, method optimization, method bridging, method performance monitoring, investigations (deviations, system suitability failure, OOT, OOS), CAPA, change control, and continuous method improvement initiatives.
• Lead and manage reference standard program, critical reagent program, extended characterization strategies and testing, forced degradation/stress sample study, comparability, and specification setting.
• Ensure analytical activities performed internally and at external partners are scientifically rigorous, comply with cGMP, ICH, USP, global regulations, and QbD principles, and align with industry’s best practices and company quality standards.
• Authoring and ownership of regulatory CMC analytical sections, as well as the ability to provide technical input across all CMC-related sections.
• Scale analytical capabilities, oversee equipment qualification and maintenance, implement workflows and LIMS, and design/establish non‑GMP development lab area.
• Signature authority for all analytical documents and data.
• Partner closely with Quality Control and Quality Assurance to establish, maintain, and oversee analytical quality, GMP compliance infrastructure, and inspection readiness for internal and external analytical documents and data.
• Other duties/responsibilities as assigned.

This position has supervisory responsibilities.

• Advanced degree (PhD preferred) in Biochemistry, Biophysics or a related discipline, with 8+ years of biopharma industry experience, of which at-least 4 years in management role, in analytical development for biologics.
• Deep hands‑on expertise in A280, HPLC, CE, LC‑MS, ELISA, and cell-based potency methods for biologics. Experience in flow cytometry desired.
• Proficient in trend analysis and simple statistical analysis.
• Strong understanding of phase‑appropriate analytical control strategies, method validation, method transfer and applicable guidelines (ICHQ2R2, ICH Q14, FDA guidance documents, USP chapters etc.)…