Technical Delivery Manager

Roles and Responsibilities

• Manage technical delivery projects from initiation to closure, ensuring timely completion within budget and quality standards.
  
• Develop and maintain strong relationships with clients through effective communication, understanding their needs, and providing solutions.
  
• Oversee project execution by coordinating with cross-functional teams, including sales, marketing, operations, and finance.
  
• Ensure compliance with company policies, procedures, regulatory requirements, and industry standards throughout the project lifecycle.
  
• Identify opportunities for business growth through strategic planning and development initiatives.

• 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.

• 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.

• 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.

• 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.

• Foster the teams technical and leadership capabilities; mentor and prepare for future roles.

• Encourage vendor-supported staff re-training on equipment, as needed.
  

Desired Candidate Profile

• 10-20 years of experience in analytical research & development (AR&D), analytical method development/validation/execution/validation (AMDE/AMV/AEX/AV).
  
• Strong expertise in HPLC analysis, GC analysis (including GC-MS), LCMS analysis (Nitrosamines, Extractable & Leachables Studies) instrumentation operation.
  
• Experience working on ICP-MS or Ion Chromatography techniques is an added advantage.
  
• Proven track record of successful business development & project management skills with ability to lead multiple projects simultaneously.