Associate Director, Technical Services

Responsibilities

Technical Strategy and Lifecycle Leadership

• Develop and execute the site Technical Services strategy and roadmap in alignment with product lifecycle, manufacturing, quality, compliance, and business priorities.
• Translate business, product, and regulatory needs into scalable and compliant technical solutions.
• Provide technical governance for process knowledge, product and process lifecycle documentation, technical standards, and knowledge transfer.
• Establish priorities, resource plans, and performance objectives for the Technical Services organization.

Technology Transfer and Process Introduction

• Lead or oversee development-to-commercial technology transfers, including technical assessments, transfer plans, process readiness, documentation, training, validation support, and post-transfer monitoring.
• Ensure transferred processes, analytical interfaces, specifications, critical process parameters, and critical quality attributes are understood and appropriately controlled.
• Coordinate cross-functional readiness for new products, process changes, equipment introductions, scale-up, and manufacturing network transfers.
• Ensure technical transfer risks, assumptions, acceptance criteria, and unresolved issues are documented, assigned, and escalated through appropriate governance.

Manufacturing Process Support and Technical Problem Solving

• Provide technical leadership for manufacturing investigations, process deviations, atypical trends, OOS, Out of Expectation, and Out of Trend events when technical or process expertise is required.
• Lead structured, data-driven root cause analysis for complex process and product performance issues and ensure conclusions are supported by objective evidence.
• Define and oversee technical studies, engineering trials, sampling plans, data analyses, and confirmatory work needed to evaluate process performance and product impact.
• Provide timely technical recommendations for containment, batch disposition support, process recovery, and recurrence prevention in partnership with the Quality Unit.

Process Optimization, Validation, and Continued Process Verification

• Drive process optimization and capability improvement using statistical analysis, process knowledge, risk management, automation, and continuous improvement methods.
• Support process validation, cleaning validation, equipment qualification, computer system validation interfaces, and implementation of manufacturing changes within the approved validated state.
• Establish and monitor process performance indicators, control strategies, continued process verification data, and product quality trends to identify emerging risks and improvement opportunities.
• Ensure technical changes are evaluated for impact to product quality, patient or user safety, regulatory filings, validated state, equipment, facilities, methods, materials, suppliers, and supply continuity.

Compliance, Regulatory, and Inspection Readiness

• Ensure Technical Services activities comply with applicable cGMP requirements, approved procedures, regulatory commitments, and company standards.
• Provide technical content and subject matter expertise for regulatory submissions, agency responses, internal audits, and regulatory inspections.
• Maintain technical documentation that is accurate, traceable, contemporaneous, scientifically justified, and inspection-ready and consistent with data integrity (ALCOA+) principles.
• Support assessment and execution of CAPAs, change controls, and remediation commitments requiring technical ownership.
• Provide technical oversight of external laboratories, contract manufacturers, suppliers, and technical service providers.
• Establish clear technical expectations, deliverables, performance measures, escalation pathways, and issue-resolution mechanisms for external partners.
• Review partner performance and technical data to ensure reliable execution, data integrity, and timely resolution of risks.

People Leadership and Cross-Functional Execution

• Lead, coach, and develop a high-performing Technical Services organization with the capabilities required to support manufacturing and product lifecycle needs.
• Establish clear accountability, decision rights, succession plans, development objectives, and execution discipline across the team.
• Build strong partnerships across Manufacturing, Quality, Engineering, Validation, Regulatory Affairs, R&D, Supply Chain, and global technical functions.
• Manage departmental resources, budget, priorities, and external support in alignment with compliance risk and business needs.
• Foster a culture of scientific rigor, transparency, proactive risk reduction, innovation, and continuous improvement.

Education and Experience

Education: Bachelor's degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, or a related scientific or technical discipline. Advanced degree preferred.

Experience: Minimum 10 years of progressive experience in pharmaceutical or regulated medical device manufacturing, technical services, manufacturing science and technology, process engineering, validation, quality control, or a related technical function. Minimum 5 years of leadership experience with direct people-management, technical-program leadership, or cross-functional governance responsibility. Demonstrated experience in technology transfer, process troubleshooting, process optimization, lifecycle management, validation support, and investigation of complex manufacturing or analytical issues. Experience supporting regulatory inspections, regulatory submissions, remediation programs, or responses to agency observations.