CMC Biologics Quality Control Director, Physichemical Testing

Role Summary

CMC Biologics Quality Control Director, Physichemical Testing. Lead the Physiochemical Testing group within a GxP-compliant QC laboratory, developing and managing departmental strategies for physicochemical testing across in-process, release, stability, raw materials, contract lab testing, and regulatory submissions. Represent QC in cross-functional settings and drive compliance with regulatory requirements in bio-pharmaceutical drug development.

Responsibilities

• Oversee QC laboratory operations by managing a team of professionals and junior managers performing physiochemical CGMP testing.
• Establish and maintain strategies for method and process implementation, continuous improvement initiatives, and method transfer/validation.
• Develop strategies for special studies as applicable.
• Ensure compliance with applicable ICH, GxP and safety regulations as an educator and manager of junior staff.
• Support general GxP and data integrity compliance for internal and external contract lab testing; review and approve data and train staff in compliance or technical principles.
• Provide oversight and/or support of QC lab investigations, audits, inspections, and communications with regulatory agencies.
• Support staff who write, revise, manage and implement SOPs, work instructions, standard practices, protocols, and reports; contribute as an individual contributor as applicable.
• Engage, coach, motivate, and empower staff to align skills with roles and improve productivity and efficiency.
• Participate in critical business processes including capital equipment procurement and workforce planning.
• Design, plan, organize, analyze, and evaluate key elements of Biologics CMC QC strategy.

Qualifications

• Education: Minimum BS/MS in a relevant discipline; Preferred PhD in Biochemistry or Analytical Chemistry.
• Experience: 10‚Äì15+ years in the (Bio)pharmaceutical industry with deep technical knowledge in physiochemical testing and drug development.
• Leadership: Proven ability to build and lead a multidisciplinary team and guide matrixed cross-functional teams to deliver results.
• Project management: Administer and coordinate physiochemical testing activities; resolve issues to meet project goals; drive innovative, creative approaches to deliver results.
• Regulatory: Familiarity with regulatory expectations and interdependencies within the CMC organization.

Skills

• Specialized Knowledge: LIMS, TrackWise or VEEVA Quality Management Systems, Documentum-based systems.

Education

• Minimum: BS/MS in relevant discipline
• Preferred: PhD in Biochemistry, Analytical Chemistry

Additional Requirements

• None specified beyond qualifications; role requires leadership, regulatory understanding, and strong physiochemical testing expertise.