Program Manager - NPI

Essential Duties and Responsibilities: Program Execution and Delivery Own end-to-end delivery of NPI programs spanning tech transfer, process development, engineering runs, training runs, process validation (PPQ), and commercial handoff, coordinating across Manufacturing, Quality, Engineering, and Supply Chain. Compile and maintain integrated program timelines identifying critical path activities, key milestones, and interdependencies. Proactively identify risks and drive mitigation plans through completion. Manage program-level budgets on behalf of site leadership, including Capital Expenditure (CapEx) tracking, benefits realization reporting, and variance analysis. Ensure all NPI activities comply with PCI procedures, cGMP requirements, and applicable regulatory standards (FDA 21 CFR 211, ICH guidelines). Define and report on NPI performance metrics including launch on-time performance, validation success rate, budget variance, and cycle time from award to commercialization. Own the reporting cadence to site leadership and identify trends requiring corrective action. Client Management Serve as the primary PCI point of contact for assigned NPI clients throughout the program lifecycle, representing PCI in Joint Steering Committee (JSC) meetings, on-site reviews, and steering committee sessions. Drive Right First Time (RFT) and On Time In Full (OTIF) delivery across all client programs, proactively managing expectations and communicating status, risks, and escalations through structured governance cadences. Team Leadership Directly manage and develop a team of NPI Project Managers, setting clear performance expectations, providing coaching and mentorship, and building program management capability within the NPI function. Promote engagement and accountability at all levels of the program team, ensuring individuals understand their contributions to program success and client outcomes. NPI Strategy and Function Development Partner with the Director of NPI to define and evolve the NPI operating model, including program tiering frameworks, phase-gated process design, resource allocation models, and standardized governance structures (JSC cadences, kickoff protocols, handoff criteria). Lead the implementation of NPI strategic initiatives across the Philadelphia site, translating directional strategy into executable plans, standard work, and measurable outcomes. Contribute to the development of NPI client onboarding standards, training and readiness frameworks, and internal playbook documentation that codify how the function operates at scale. Design and own the Business Development-to-NPI handover process, defining documentation standards (TKO from Engineering, product detail sheets, launch questionnaires), technical inputs, billing setup, and internal launch preparation steps to ensure programs are fully scoped and resourced before customer kickoff. Develop and maintain an NPI training curriculum and on-the-job training (OJT) framework for Project Managers and Associate Project Managers, including standard work definitions that establish consistent execution expectations across the team. Cross-Functional Coordination and Continuous Improvement Work cross-functionally to evaluate and coordinate resource allocation across programs, ensuring appropriate capacity within each functional team and that deliverables are tracked to completion. Identify opportunities for process improvement throughout the NPI lifecycle and collaborate with PCI Global sites to harmonize ways of working on large-scale programs. Manage change at varying levels, ensuring site procedures are followed and change controls are raised with the appropriate approvers engaged from the outset. Own portfolio-level health monitoring across all active NPI programs, including schedule risk assessment, resource prioritization when constrained, validation readiness tracking, and revenue impact analysis for site leadership reporting. Build and maintain NPI reporting infrastructure in Smartsheet, including operational dashboards for program managers and executive-level dashboards for SLT, with standardized RAID logs and lessons learned integrated into every program provision. Scope and Authority Direct management of NPI Project Managers with responsibility for performance management, development, and workload allocation. Responsible for adherence to SOPs, Health & Safety, cGMP, and regulatory guidelines for themselves, their team, and any contractors under their direction. Accountable for managing and maintaining NPI program and capital project budgets. Authority to elevate program-level risks and issues to the Director of NPI and site leadership. This role requires occasional travel for vendor, supplier, or client engagements, including potential travel to PCI Global sites. Special Demands: Stationary Position: From 1/4 to 1/2 of the day. Move, Traverse: From 1/4 to 1/2 of the day. Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day. Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day. Ascend/Descend or Work Atop: Up to 1/4 of the day. Position self (to) or Move (about or to): Up to 1/4 of the day. Communicate or exchange information: 3/4 of the day and up. Detect, distinguish, or determine: 3/4 of the day and up. On an average day, the individual can expect to move and/or transport up to 10 pounds. less than 1/4 of the day. Special Vision requirements: Close Vision Distance Vision Color Vision Peripheral Vision Depth Perception Ability to focus No Special Vision Requirements Work Environment: Work is primarily performed at a desk and/or in an office environment. for 1/4 to 1/2 of the day. Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for up to 1/4 of the day. The noise level in the work environment is typically moderate. Qualifications: Bachelor’s degree in a technical, engineering, or science discipline. 7+ years of experience in pharmaceutical project or program management, including oversight of multi-million dollar NPI, tech transfer, or capital programs. Proven experience managing concurrent programs across multiple clients in a CDMO or contract manufacturing environment. Sound working knowledge of cGMP, FDA 21 CFR 211, and regulatory inspection readiness. Experience serving as the primary client point of contact, including participation in JSC meetings and steering committees. Direct people management experience, including performance management, coaching, and team development. Proficiency with project management and reporting tooling, including demonstrated ability to build dashboards, trackers, and reporting infrastructure in Smartsheet or equivalent platforms, plus Microsoft 365 suite. Effective communication across all levels, including executive stakeholders and external clients. Strategic thinking with the ability to translate high-level direction into executable plans, standard work, and scalable processes. Ability to lead and develop high-performing teams in a matrixed, cross-functional environment. Ability to build trusted relationships with both internal stakeholders and external clients. Dependability, reliability, integrity, and attention to detail. Customer-centric mindset with a commitment to quality, ethics, and professionalism. Preferred: Master’s degree in a technical, engineering, or science discipline. PMP, PRINCE2, or equivalent project management certification. Experience with tech transfer, process validation (PPQ), and commercial manufacturing readiness. Experience contributing to or building operational strategy, including process design, governance frameworks, or organizational operating models within a GMP manufacturing environment. Understanding of facility, engineering, and equipment qualification processes. Familiarity with Focus Factory or dedicated manufacturing line operating models. Experience with portfolio-level program oversight, including resource prioritization, schedule risk management across multiple concurrent programs, and executive-level reporting. Experience designing or improving commercial handover processes between Business Development and operational functions. 3rd Shift Summary of Objective The function of this position is to move material to and from the plants and to and from the offsite warehouse utilizing a tractor and trailer CDL (A) and to move and spot trailers in the yards for loading and unloading as required. This includes following all DOT regulations for pre-trip and post-trip inspections, moving materials and trailers as requested, and loading and unloading the trailers with a forklift. This position will also be responsible for completing inventory forms and inventory transactions in JDE, using barcode scanners for inventory control, investigating inventory discrepancies, assisting Engineering with equipment movement, responsible for ensuring all logistical cGMP regulations are met and adhered to, and other duties as assigned. Essential Duties and Responsibilities: Fully understand how to operate and safely drive your assigned vehicle Drive trucks with a Gross Vehicle Weight (GVW) over 26,000 lbs. Safely and efficiently handle and unload goods at the destinations Communicate with the plant and warehouse to ensure timely movement Confirm contents of each load match the move sheets Perform inspections of your vehicle before and following each trip Always ensure the equipment is kept clean Maintain and service vehicles as needed Notify managers of any major maintenance or transport issues encountered Adhere to company rules and regulations Obey all applicable traffic laws and drive according to the weather/road conditions Always making safety a priority Communicate effectively with all levels of the organization. Complete inventory forms and inventory transactions in JDE Use barcode scanners for inventory control Investigate inventory discrepancies Assist Engineering with equipment movement. Responsible for ensuring all logistical cGMP regulations are met and adhered to. Maintain compliance with warehouse records and logbooks Perform forklift battery maintenance functions by checking water levels, charging batteries, and changing batteries in the fork trucks. This position may require overtime and/or weekend work. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, and rules. Attendance at work is an essential function of this position Performs other duties as assigned by the Manager/Supervisor. Qualifications: Skills testing requirements met at approved grade level for position. 2+ years proven experience with tractor-trailer Basic Mathematical Skills Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs. Limited Working Proficiency: The ability to satisfy routine social demands and limited work requirements. The ability to read simple prose, in a form equivalent to typescript or printing, on subjects within a familiar context. Basic Reasoning: Ability to apply common-sense understanding to carry out uninvolved written or oral instructions. Ability to deal with problems that involve only a few concrete variables in standardized situations. Valid Class A driver’s license required Clean driving record with no moving violations Skilled at driving large vehicles Comfortable maneuvering and parking a tractor-trailer Alert, focused, and detail-oriented Physically and mentally fit Ability to lift up to 50 lbs. at a time Able to operate an electric lift, hand trucks, pallet jacks, etc. Disciplined, dependable, and resourceful Preferred: Ability to display excellent time management skills. Ability to display a willingness to make decisions. Ability to demonstrate attention to detail. Ability to identify and resolve problems on time. Equal Employment Opportunity (EEO) Statement: PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status. At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture. #J-18808-Ljbffr PCI NH Lyophilization Services of New England