Sr. Group Leader- Analytical Services- Pharma

The role of Senior Group Leader- Analytical Services provides daily operational support for our scientists focused on Stability, ARD and QC work for pharmaceutical and biopharma clients.  This includes management and direction of laboratory staff and overseeing lab activities, quality measures, project timelines and execution, and overall compliance in a cGXP/cGMP lab environment.  Support for consults, customer and regulatory audits and a focus on process and operational improvements to optimize service and quality is required. Experience with analytical chemistry method development and validation following USP/EP/JP and related compendia is required. A strong working knowledge of analytical method development best practices is also needed, along with an understanding of analytical equipment validation and maintenance activities.  Leadership and technical competency are required in this role for method development and validation of small molecule API and drug products including phase-appropriate method development and validation or method transfer to support early-phase clinical development to commercialization.  Development of effective and efficient lab processes, including test procedures and lab reports in support of regulatory submissions for marketing approval of pharma products in the US, EU and globally is required for success in this role.

Essential job functions:

Lab Operations Management

• Supervise a tiered organizational structure comprised of technical leads, chemists and lab analysts working in the analytical services group supporting pharmaceutical product testing. 
• Ensure strong service delivery and professional service standards to meet client expectations.
• Responsible for revenue and expense control of laboratory operations, in line with approved organizational budgets and business strategies.
• Annual budgeting for operations and capital expense priorities in collaboration with finance.
• Prepare and implement SOPs and operational policies for effective lab management.
• Ensure efficient and effective allocation, scheduling and management of laboratory resources. 
• Oversee compliant use of analytical equipment, LIMS and Project Management tools including required maintenance, re-qualifications and replacement planning. 
• Collaborate with Quality and Validation teams on system and equipment IQ/OQ/PQs.
• Regularly communicate to staff quality related issues and quality improvement actions.
• Perform periodic GHP/GDP spot checks to ensure lab procedures, quality policies and safety guidelines are adhered to; address performance or training needs as required.
• Lead analytical OOS/OOT investigations and assist process investigations to closure.
• Review and approve laboratory investigations, deviations, and actionable audit findings.
• Conduct relevant periodic meetings with all direct reports and the analytical team members.
• Ensure proper safety training and compliance in collaboration with EHS and CHO.

Stability, ARD & QC Business Activities

• Prepare and approve proposals to inform timelines and budgets, including project scope of work documents and coordination with sales or business development on project pricing.  
• Respond to client inquiries and lead technical meetings on project scope of work development. 
• Provide recommendations to clients on analytical and compliance issues for product testing.
• Review and approve study protocols, project status reports, final study reports and other project-related technical documents, as needed.
• Review and approval of timesheet reports for billable project hours.
• Review of lab data for technical quality and compliance to protocols, methods and SOPs. 
• Author/review documentation to support new and existing commercial products (methods, SOPs, transfer protocols/reports, lab notebooks, technical reports, etc.)
• Manage outsourced services for analytical test services, where appropriate.

Regulatory Compliance

• Provide appropriate audit support for internal and external audit teams.
• Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc).
• Know and follow company policies and procedures.

Professional Development

• Represent as a scientific expert within the industry; participating in seminars and trade shows as needed for sales and marketing support of the Stability, ARD & QC business line.