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Job Summary

Responsibilities:

Typically leading 2-5 projects each with 4-10 team members and supported by a Project Coordinator per project. Project duration is generally more than 18 months.
Delivery of assigned projects on budget, on schedule, and on scope, with appropriate profitability, governance, communication, project management discipline, and risk management.
Organizes, manages and leads projects from specification to turnover, for processes and equipment, outside of routine production, including:
New business development
Contract Product development
Contract Manufacturing
Technology transfer
Product launches
Inter-site harmonization
Manufacturing compliance.
Alternative supplier sourcing and qualification
Supports Sr. PM with projects and programs including new business development.

Responsibilities

Leads cross-functional teams including Managers, Leads and/or Specialists from: Production, Engineering, Development \& Formulation, Technical Services, Validation, QA, QC, Microbiology, RA, EHS, Supply Chain, etc.
Generates and maintains project charters, project plans, action plans, project schedules, resource plans and tracking documents, meeting minutes, presentations, reports, and other project-related documentation in compliance with any contractual or stakeholder requirements and company practices \& procedures
Works with project team to create and execute detailed project work packages and revise them to meet changing needs and requirements to ensure milestones are met effectively and efficiently.
Responsible for project governance and accountable to Internal and External Steering Teams and Sponsors for delivery of project on scope, on plan, and on budget, as well as to functional managers for team members' performance management issues
Leads weekly PM team meetings re. priorities and tasks for the week. Represents specific projects at regular finance review meetings
Identifies, validates, and prepares change orders including cost estimate to execute. Once approved incorporates change into schedule, budget and executes on plan, on schedule, on budget
Conducts risk assessments to identify project risks and mitigations; escalates identified risks and recommendations for mitigation to management, clearly identifying the needed support
Effectively communicates project challenges with internal stakeholders and team members. Facilitates collaboration between suppliers, project team and SMEs throughout project. Corresponds with external contractors, vendors, and other 3rd parties according to project requirements
Prepares cost analysis, estimating effort and costs for the new opportunity. Consulting with BD, documents project objectives, scope, deliverable timeline, justification, and resources. Completes supporting worksheets and provides BD to complete and submit to Client
Serves as main point of contact for CDMO clients to provide updates and resolve project challenges. Delivers a high customer-value experience
Documents formal closure of a project with appropriate approvals from Client, Sponsor and stakeholders. Execute appropriate closure or termination tasks. Completes all necessary PM templates, procedures including disposition of client-owned materials and equipment
Executes all projects in compliance with PM office PMO policies, procedures and practices, utilizing and maintaining the standard tools, templates, website. May lead the review/revision of same, and adds to the PMO body of knowledge. Designs and delivers training on new PMO practices as appropriate
Executes work in a way that is compliant with GMP, EHS, and other company policies and procedures, following regulatory guidance, safety rules and regulations, standard business practices, and at all times embodying the company Mission, Vision and Values

Qualifications

Bachelor of Science or Engineering / Engineering Science degree from a recognized academic institution is a requirement.

Experience \& Skills

Minimum of 5 years of experience in leading projects or initiatives in a manufacturing environment, preferably in pharmaceutical CMO/CDMO manufacturing.
Pharmaceutical industry experience is a plus.
Project Management Professional (PMP) certification is preferred.
Excellent communication, interpersonal and customer service skills including effective meeting facilitation and presentation skills.
Ability to deal with difficult situations in high-pressure environments in a professional manner.
Significant experience and skill presenting in front of clients at a leadership level, through both written and verbal communication.
Excellent organizational skills with strong attention to detail.
Strong planning and organizational skills with detail oriented.
Proficiency with Microsoft Office applications, including Project, Excel, Word, Vision and PowerPoint.
Understanding and routine application of Good Manufacturing Practices, Good Laboratory or Clinical Practices and Product Development Processes required.
Demonstrates initiative, ownership, effective problem-solving, self-motivation, and is a team player.
Able to periodically travel internationally in support of projects when required.

Under Qualifications

Excellent compensation/benefits package.
Bonus and reward programs
Discounted gym memberships
Programs supporting work life balance
Employee recognition program
Professional and personal development programs
Social events and spirit days

Minimum Level Of Education Required

Minimum Level Of Experience Required

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