CMC Biologics Quality Control Director, Physichemical Testing

Role Summary

CMC Biologics Quality Control Director, Physichemical Testing. Lead and oversee the Physiochemical Testing group within a GxP-compliant QC laboratory, directing strategy, method development/transfer/validation, and regulatory readiness for in-process, release, stability, raw materials, and contract lab testing in support of preclinical, clinical, and commercial activities.

Responsibilities

• Overseeing QC laboratory operations by managing a team of professionals and junior managers who execute physiochemical CGMP testing.
• Establishing and maintaining strategies for method and/or process implementation, continuous improvement initiatives, and method transfer and validation processes.
• Developing strategies and approaches for special studies, as applicable.
• Ensuring compliance with applicable ICH, GxP and safety regulations as an individual contributor as well as an educator and manager of junior staff.
• Supporting general GxP and data integrity compliance in both routine and non-routine work activities for both internal and external contract lab testing, including data review/approval and staff training.
• Providing oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies and health authorities.
• Providing support for staff who identify, write, revise, manage and implement standard operating procedures, work instructions, standard practices, protocols, and reports.
• Engaging, coaching, motivating and empowering staff to ensure their skills match their roles and to continually develop, thereby improving productivity and efficiency of the department operations.
• Participating in capital equipment procurement, workforce planning, and other critical business processes.

Qualifications

• Education: Minimum: BS/MS in a relevant discipline; Preferred: PhD in Biochemistry or Analytical Chemistry.
• Experience: 10-15+ years (BS/MS/PhD) in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing applications and one or more areas of drug development.
• Leadership: Proven ability to create and maintain a productive multidisciplinary team; lead matrixed and cross-functional teams; administer and coordinate physiochemical testing activities; resolve issues to meet project goals; foster an innovative/creative culture.
• Specialized Knowledge: LIMS, TrackWise or VEEVA Quality Management Systems, Documentum-based systems.