Director, Packaging and Manufacturing Operations

Thermo Fisher Scientific•Allentown, PA

2d•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 the Allentown site. The role provides strategic and day-to-day leadership across primary and secondary packaging operations, manages the technical operation team, and works closely with Quality, Project Management, Engineering, Operational Excellence, Finance and other site functions to deliver customer commitments while maintaining cGMP compliance and a strong safety and quality culture. The Director translates site and division priorities into an operating strategy for the department; builds leadership capability; establishes capacity, staffing and capital plans; drives performance through tiered daily management and Practical Process Improvement (PPI); and owns escalation and recovery when safety, quality, delivery, cost or customer performance is at risk. As a member of the Allentown Site Leadership Team, the role carries leadership responsibility beyond Packaging and Manufacturing Operations and is expected to shape site culture, strategy and overall performance. The Director is a visible role model, drives cross-functional alignment and accountability, and helps advance the site’s transformation and continuous improvement agenda. The position is primarily administrative and office-based, with regular presence in operational areas.

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 convert strategy into priorities, establish management systems, make timely risk-based decisions and hold leaders accountable for results.
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 data use, root-cause analysis, standard work, visual management and Lean/PPI methods.
Strong business and financial acumen, including understanding 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, with 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 or 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.
Clinical packaging and labeling experience, particularly in clinical trial supply operations.
Experience leading significant capital, capacity expansion, technology implementation or operational transformation initiatives.

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 to customer demand, backlog, capacity constraints and financial commitments; lead recovery plans when performance deviates from plan.
Establish operating rhythms, including daily management boards, Gemba walks, performance reviews and escalation mechanisms.
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 in partnership with Quality; verify effective and sustainable corrective and preventive actions.
Review and approve applicable SOPs, change controls and operational risk assessments; ensure 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 a strong 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 to 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 by 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; present routine performance reporting for safety, quality, delivery, productivity and cost.
Partner with Finance on budget management, backlog visibility, forecasting, productivity and capital planning; understand operational drivers of financial performance and act 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, effective decision-making, barrier removal and shared site and business objectives.
Model Thermo Fisher Scientific values and leadership behaviors and promote safety, quality, continuous improvement and customer focus.