CMC Biologics Quality Control Director, Physichemical Testing

Role Summary

The CMC Biologics Quality Control Director, Physiochemical Testing leads the QC laboratory for physiochemical CGMP testing in support of preclinical, clinical and commercial programs. This role develops, implements and manages departmental strategies for physiochemical testing across product in-process, release and stability testing, raw materials testing, contract lab testing, and regulatory submissions. The incumbent may participate in or provide oversight of CGMP analytical method lifecycle, including management of reference standards, assay controls, critical reagents and materials, product specifications and sampling plan processes. The incumbent should possess a practical understanding of bio-pharmaceutical drug development and GxP requirements, with knowledge of local, regional and global regulatory compliance (ICH, GMP, EPA, OSHA, DEA) as integral responsibilities.

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 review and approval of data in raw and reported forms, and training staff in compliance or technical principles.
• 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, as an individual contributor where applicable.
• 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 critical business processes, including but not limited to capital equipment procurement and workforce planning.

Qualifications

• Education: Minimum: BS/MS in relevant discipline; Preferred: PhD in Biochemistry, 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/Collaboration: Champion the creation and maintenance of a productive multidisciplinary team while working effectively with team members and management; Represent QC as a leader who effectively guides matrixed and cross functional teams to successfully deliver business results; Administer and/or coordinate all aspects of the project/program’s physiochemical testing activities; Utilize expertise and leadership skills to direct staff and to resolve issues to ensure project goals are met; Drive an innovative/creative culture in delivering business results; Account for the performance and results of the physiochemical functional area as well as support the performance and quality of results for the QC department; Understand and lead others through the interdependencies of various functions within the CMC organization; Design, plan, organize, analyze, and evaluate key elements of Biologics CMC QC strategy

Skills

• Specialized knowledge: LIMS, TrackWise or VEEVA Quality Management Systems, Documentum Based Systems