Director, Packaging and Manufacturing Operations

Thermo Fisher Scientific•Allentown, PA

21h•Onsite

About The Position

The Director, Packaging and Manufacturing Operations is the senior operations leader accountable for safe, compliant, reliable and cost-effective execution of clinical packaging and labeling activities at Thermo Fisher Scientific’s Allentown site. The role provides strategic and day-to-day leadership across primary and secondary packaging operations, manages the technical operations team, and partners with Quality, Project Management, Engineering, Operational Excellence, Finance and other site functions to meet customer commitments while maintaining cGMP compliance and a strong safety and quality culture. The Director translates site and division priorities into departmental operating strategy, builds leadership capability, establishes capacity, staffing and capital plans, drives performance through tiered daily management and Practical Process Improvement (PPI), and leads escalation and recovery when safety, quality, delivery, cost or customer performance is at risk. As a member of the Allentown Site Leadership Team, the Director helps shape site culture, strategy and performance, and advances transformation, operational excellence, customer service and employee engagement. Thermo Fisher Scientific’s Clinical Trials Division partners with pharmaceutical and biotech customers worldwide to provide services including project management, packaging, distribution, transportation management, specialty logistics, ancillary supply management, clinical supply optimization and bio-repository storage. The division has more than 3,000 employees in over 15 countries and emphasizes its commitment that “There is a Patient Waiting.”

Requirements

Bachelor’s degree in engineering, science, operations, business or a related discipline.
10+ years of progressive experience in pharmaceutical, biotechnology, medical device, food, chemical, cosmetics or other highly regulated manufacturing or packaging operations, including substantial experience in an FDA-regulated cGMP environment.
Demonstrated experience leading through managers in a complex, multi-shift operations environment with accountability for safety, quality, delivery, cost and people performance.
Experience leading Lean/PPI or comparable continuous improvement systems and delivering measurable, sustained operational improvement.
Experience with capacity planning, workforce planning, budgeting, capital planning and cross-functional execution.
Deep working knowledge of cGMP operations, quality systems, SOP governance, change control, deviation and investigation practices, CAPA, and inspection and audit readiness.
Ability to translate strategy into priorities, establish management systems, make timely risk-based decisions and hold leaders accountable for results.
Demonstrated ability to lead and develop managers, build succession depth, manage performance and create an engaged, accountable organization.
Advanced problem-solving and continuous improvement capability, including use of data, root-cause analysis, standard work, visual management and Lean/PPI methods.
Strong business and financial acumen, including understanding of labor and capacity drivers, productivity, backlog, budgets, forecasts, capital investment and cost tradeoffs.
Ability to integrate competing customer and business priorities, manage ambiguity and lead through operational disruptions and change.
Excellent written, verbal and executive communication skills, including the ability to communicate with frontline teams, technical functions, customers and senior leadership.
Strong collaboration and influencing skills across Quality, Project Management, Engineering, Finance, HR, Supply Chain and other site and division partners.
Working knowledge of packaging operations and equipment, production metrics and process capability sufficient to challenge assumptions, identify risk and guide technical and operational decisions.
High standards of integrity, safety, quality, customer focus and personal accountability.

Nice To Haves

Advanced degree in a relevant discipline.
Lean/Six Sigma, operations, packaging, quality, supply chain or related professional certification.
Experience in clinical trial supply packaging and labeling operations.
Experience leading significant capital, capacity expansion, technology implementation or operational transformation initiatives.
Clinical packaging and labeling experience is strongly preferred.

Responsibilities

Provide overall leadership for Packaging and Labeling Operations across all shifts, with accountability for safety, quality, service, productivity, cost and schedule performance.
Translate site and business objectives into annual and multi-year departmental priorities, operating plans, resource requirements, budgets and measurable performance targets.
Align production plans, labor, equipment and support resources with customer demand, backlog, capacity constraints and financial commitments; lead recovery plans when performance deviates from plan.
Establish daily management boards, Gemba walks, performance reviews and escalation mechanisms to support visibility, accountability and timely decisions.
Embed cGMP, SOP, data integrity, safety and regulatory requirements in daily operations and leadership behaviors.
Ensure timely investigation, escalation and resolution of quality events, deviations, rejects and recurring operational issues with Quality; verify effective and sustainable corrective and preventive actions.
Review and approve applicable SOPs, change controls and operational risk assessments, ensuring risks, controls, owners and implementation plans are defined.
Maintain inspection and audit readiness and ensure leaders and employees are trained and qualified for assigned responsibilities.
Lead, coach and develop managers and leaders; set expectations, goals and accountability, and build succession plans and an operations talent pipeline.
Develop staffing and organizational plans aligned with business demand, capabilities and shift coverage; partner with Human Resources on workforce planning, performance management, employee relations and organizational effectiveness.
Build an inclusive, engaged, high-performing culture characterized by ownership, disciplined execution, collaboration and continuous learning; ensure consistent application of company policies and leadership standards.
Own the operational excellence agenda for Packaging Operations and sponsor PPI/Lean initiatives that improve safety, quality, flow, right-first-time performance, labor productivity, equipment effectiveness, changeover performance and cost.
Use data and root-cause problem solving to identify systemic constraints and recurring losses, prioritizing improvement work based on business and customer impact.
Define equipment, engineering and capital requirements to sustain compliance, increase capacity, improve reliability and enable growth; develop business cases and ensure effective operational implementation.
Partner with Engineering and technical functions on equipment lifecycle, process capability, new or changed processes, and operational readiness for upcoming projects.
Partner with Project Management and customer-facing functions to resolve operational questions, manage priorities and support dependable execution of client commitments.
Communicate performance, risks, constraints and required decisions to the General Manager and site leadership; provide routine reporting on safety, quality, delivery, productivity and cost.
Partner with Finance on budget management, backlog visibility, forecasting, productivity and capital planning; understand operational drivers of site financial performance and take action to close gaps.
Act as a senior site leader and cross-functional partner, balancing departmental priorities with overall site performance and patient and customer needs.
Build collaborative partnerships across site functions to drive alignment, enable decisions, remove barriers and deliver shared site and business objectives.
Model Thermo Fisher Scientific values and leadership behaviors, promote safety, quality, continuous improvement and customer focus, and reinforce the Clinical Trials Division commitment that “There is a Patient Waiting.”