Sr. Program Manager, NPI

Philadelphia, PA, United States

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Summary of Objective:

The Sr. Program Manager (NPI Focus) is primarily responsible for leading assigned large new product introduction programs. This includes developing and executing project timelines, program team leadership, developing processes and methods to introduce new facilities, new equipment, and qualification and commissioning work to ensure projects meet committed timelines, budgets, and customer launch schedules. The Sr. Program Manager will lead cross-functional teams across the site, as well as utilize third party expertise, to ensure best practices are followed to execute these critical projects and ensure launch excellence. The Sr. Program Manager may also have responsibilities to support commercial production activities for new products following initial launch.

Essential Duties and Responsibilities:

1. Ensures all assigned programs and their workstream projects are executed safely, on time, and within budget to specified scope using Key Performance Indicators to measure performance and keep projects on track.

2. Responsible for all aspects of assigned key New Product Introductions (NPI) programs. Aligns with site Business Unit Leaders to execute successful New Product Introductions (NPI) to meet client expectations for specified scope.

3. Ensures well developed charter and project plan for each project with full buy-in from both internal and external customers. Comprehensive, integrated project plans will capture details across all functional areas, with particular emphasis on the critical path. Manages to program and project scope and presents scope changes to customer and internal stakeholders for approval.

4. Develops a resource plan for each project that includes full-time team members (e.g., NPI Engineers, Quality Engineers), part-time team members (e.g., Finance), and third parties. Ensures this plan is covered by the project budget and supported by PCI functional leadership.

5. Collaborates with site General Manager and site functional area leaders to identify all key project team roles in the organization and ensure uniform people development into these roles.

6. Leads internal and external Program Governance. Develops and delivers regular updates to customers, PCI Steering Committee, and/or ELT as requested.

7. Third party resources will be used when internal expertise does not exist or when workload exceeds team's capacity.

8. Implements and train on project management principles, best practices, methodologies, tools, systems, and governance.

9. Determines appropriate technology, equipment, facilities, and utilities to meet project goals, timelines, and budget.

10. Uses accepted project management principles, tools (e.g., FMEA), and practices to minimize and mitigate risks and proactively identify issues before they arise and develop timely corrective actions as appropriate.

11. Leads program and project teams to deliver corporate, segment, and site growth objectives in an accountable and collaborative way.

12. Conducts Business Unit project management activities to support commercial production of launched products.

13. Delivers cost savings through equipment vendor negotiations, innovative solutions, standardization, and best practices. Partners with maintenance, operations, and other internal customers to ensure installations are completed on time with the correct support and collaboration for an effective handoff for ongoing production. Demonstrates operational background in cGMP environment, preferably in pharmaceutical manufacturing / packaging / validation.

14. Instills a strong culture of Lean and Continuous Improvement into Program Management.

15. Works closely with Engineering, Quality, Manufacturing, EH&S, Sales, and site Project Management to ensure internal and external clients' requirements are met.

16. Correctly employs industry best practices that will successfully withstand inspections by regulatory authorities.

17. Furthers PCI's Environmental, Social and Governance culture and program.

18. Participates in the management of the site's capital expenditure budget and associated cash flow as it relates to program execution.

19. Performs other duties as assigned by Manager.

Special Demands:

* Stationary Position: From 1/4 to 1/2 of the day.* Move, Traverse: From 1/2 to 3/4 of the day.* Operate, activate, use, prepare, inspect, or place: None* Install, place, adjust, apply, measure, use, or signal: None.* Ascend/Descend or Work Atop: None.* Position self (to) or Move (about or to): From 1/4 to 1/2 of the day.* Communicate or exchange information: 3/4 of the day and up.* Detect, distinguish, or determine: Up to 1/4 of the day.

On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.

Work Environment:

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

Ø Work is primarily performed at a desk and/or in an office environment. for 1/2 to 3/4 of the day.

Ø 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.

Ø Work near moving mechanical parts for up to 1/4 of the day.

The noise level in the work environment is typically, quiet.

Required Qualifications:

* Bachelor's Degree in engineering or a scientific field and 10-15 years related experience and/or training.* Pharmaceutical or Life Science experience* Significant experience managing projects, programs, and cross-functional teams* Ability to set and achieve challenging goals.* Ability to effectively present information to various stakeholders as the job requires.* Familiar with PMI PMBOK, lean and six sigma* Ability to prioritize multiple ongoing projects and activities to meet customer and company timelines* Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.* Location requirement: Onsite, based on program requirements* Some travel will be required ~ 20%

Preferred Qualifications:

* Master's Degree (M.S.) in related field and/or 10+ years related experience or training.* Project Management Professional (PMP) credential* Lean & Six Sigma Certifications

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future

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.

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