Senior Biologics Analytical LCM Portfolio Lead

BioLife Plasma; Lexington (MA); Sur place; USD 220 000 - 320 000; Plein temps

Résumé du poste

BioLife Plasma is seeking a Senior Director to lead Biologics Analytical LCM Oversight, driving strategy across development and lifecycle management. You will manage program leads, align with QA/QC/Regulatory/IT, and push AQbD and risk-based decisions to ensure robust control strategies for monoclonal antibodies, ADCs, and related biologics.

You will foster cross-functional collaboration, advance analytical technology, and build a leadership network to deliver scalable, compliant solutions

Qualifications

• BS/MS in Biochemistry, Biology, Biotechnology, Chemistry, Pharmaceutical Sciences, or related discipline; PhD preferred.
• 12+ years in pharma/biotech with depth in Analytical Development and/or QC, leading multiple biologics analytical programs.
• Experience developing analytical and holistic control strategies and supporting regulatory submissions (IND/IMPD/BLA/MAA).
• Strong understanding of AQbD, risk-based validation/verification, robustness, and method lifecycle management.
• Broad oversight across biologics analytical modalities and enabling systems (CDS/LIMS/ELN).
• Experience supporting regulatory submissions and approvals.
• Strong communication and stakeholder management.
• Platform modernization and scaling new analytical approaches.

Responsabilités

• Own the global Analytical LCM Biologics Portfolio Strategy from late development through commercial.
• Maintain program roadmaps and Method Risk Registers with cross-functional alignment.
• Collaborate with QA, QC, Regulatory, IT to ensure integrated control strategies.
• Directly lead and develop Analytical LCM program leads and establish accountability.
• Drive analytical technology innovation and platform embedding in LCM plans.

Connaissances

Strategic leadership

Cross-functional collaboration

Regulatory submissions

AQbD / risk-based thinking

Analytical method development

Communication skills

Project management

Formation

BS/MS in Biochemistry/related field

PhD preferred

Outils

CDS

LIMS

ELN

Description du poste

BioLife Plasma is seeking a Senior Director to lead Biologics Analytical LCM Oversight, driving strategy across development and lifecycle management. You will manage program leads, align with QA/QC/Regulatory/IT, and push AQbD and risk-based decisions to ensure robust control strategies for monoclonal antibodies, ADCs, and related biologics.

You will foster cross-functional collaboration, advance analytical technology, and build a leadership network to deliver scalable, compliant solutions