Sr. Project Manager - Technical Services

About the role

We are committed to building a diverse and inclusive team and encourage applications from candidates of all backgrounds. We are seeking a talented and motivated Sr. Project Manager, Technical Services to join our team.

Responsibilities

• Manages and delivers organizational and project leadership for Generic commercialization, Site Transfers, Buy-ins, Third Party, Alternate API, process changes (Quality & Product Robustness driven) and changes to Active Pharmaceutical Ingredients, Excipient, Packaging and Raw Material items.
• Proactively identifies & manages risk which could adversely affect successful project completion.
• Lead & facilitate multiple cross-functional team by managing and directing project team resources / experts to identify relevant issues and effectively manage progress and change.
• Ensures integration of technical/commercial information and activities necessary to develop and support the success of the plan by utilizing project management skills/tools, including but not limited to, to successfully drive the project to meet established timelines:
• Project Plan
• Meeting Minutes/Agendas
• RID log
• Costing assessments
• Meeting facilitation (Core & relevant sub-teams)
• Affords critical data and contributes information to identify / facilitate critical “Go / No Go” project decisions. Provides proactive communication to all stakeholders, regarding issues, risks, contingency plans and potential negative impacts to the established milestones and timelines.
• Be change leaders ensuring change management requirements are being facilitated i.e. Initial change notification assessment (SME assessment, cost evaluation, Master Change assessment), Management of Tactical and Strategic change meetings, Creation of required Protocols (Change & Master Change), Creation of Qualification Technical Reports, Management of CC’s in appropriate system, Stage/Que/Monitor work in-progress, Development/Management implementation plan, Ensure Document review prior to final implementation, Assess completed projects for lessons learned to drive improvement in project performance/execution and capture data to drive/refine resource allocation/costing for future projects.
• Mentor and develop other members of the Technical Services department. Act as a subject matter expert on core technologies and/or project management topics (e.g. meeting facilitation, influence, risk management, etc.).
• Lead knowledge sharing, individual skill development, and career development within the department, through sharing and implementation of best practices in both individual and group settings (e.g. 1:1 mentoring regarding a specific product/process challenge, and in PC meetings/staff meetings, respectively).
• Identify and proactively create opportunities to mentor/job shadow with Junior Project Managers on specific equipment and process technologies (e.g. bringing Junior Project Managers to the shop floor during production and/or troubleshooting support), and on project problem solving (e.g. risk mitigation of various end to end supply chain trends of potential concern during peer review of a Junior Project Manager’s project, provide mentoring on recommend approaches for analysis and remediation, if needed).
• Lead skill development of Junior Project Managers in the competency of Planning/Organizing, Critical Thinking, Problem Solving/Resolution, and Influence.

Qualifications

• B.S. degree in a scientific and/or related operations discipline plus a minimum of 9 years’ experience in pharmaceutical (multi-disciplinary experience: change management, analytical and/or drug regulatory affairs preferred) and/or project management.
• Alternatively, a M.S. degree in a scientific and/or related operations discipline plus a minimum of 7 years’ experience in pharmaceutical (multi-disciplinary experience: change management, analytical and/or drug regulatory affairs preferred) and/or project management.
• Minimum 9 years of industrial multi-disciplinary experience managing multiple, complex projects and/or implementing continuous improvement.
• Expert knowledge and understanding of applicable regulations pertaining to the development and manufacturing of pharmaceuticals including cGMP, DEA, and FDA, EMEA.
• Demonstrated knowledge of SOP’s, production processes and equipment and have strong understanding of pharmaceutical supply chain operations, business analysis, and pharmaceutical technology. In addition, demonstrated knowledge of pharmaceutical development, scale-up and validation, and lifecycle processes.
• Expert knowledge and understanding of project management methodology with an active PMP certification with the ability to effectively manage and partner with subordinates, peers, suppliers and contractors.
• Demonstrated ability to deliver on results to meet determined business objectives/targets.
• Demonstrated ability to communicate effectively (oral and written) both internally and externally at various levels locally, regionally & globally

Competencies

• Critical Thinking: Ability to work in uncharted areas; capable of integrating large amounts of information to address complex issues. Challenges conventional wisdom when required. Intellectually aggressive with a strong end-product orientation.
• Complex Problem Solving: Expert knowledge and ability to apply investigative techniques to uncover problem areas, determine root causes, and drive corrective actions at both the individual and cross-functional team level. Uses problem solving abilities requiring attention to detail, accuracy, and scientific judgment. Develops solutions to a variety of problems of high scope and complexity, as defined in Accountabilities section.
• Project Management: Experience managing and leading projects and/or process improvements teams of high scope and complexity.
• Initiative: Works independently on activities ranging from strategic decisions to tactical execution of tasks with high complexity. Exercises latitude in determining objectives and approaches to assignments.
• Organizational Skills - Able to operate independently. Manages time well, follows through on commitments and pays attention to details. Able to work on several projects simultaneously.
• Teamwork: Demonstrated ability to be influence team members and senior leaders on topics of high complexity, and to lead/facilitate teams on tasks of high complexity.
• Coaching/ Mentoring/Influencing: Strong ability to coach and/or mentor/influence both in and out of reporting structure. Foster the professional development by willing sharing of personal knowledge and experience enabling individuals and teams to higher levels of performance.