Project Manager

Overview:

The purpose of this document is to outline the scope of work for an external Operational Readiness Project Manager. The primary objective for this role is to provide support and oversight for the Filling and Operational Readiness work packages in the Aseptic Production. The successful candidate will be responsible for overseeing the General Master Batch Record (GMBR) implementation, training, and testing for filling operations, while also providing detailed support for other filling-related tasks outlined in the site project plan.

Responsibilities:

• Leading multi-disciplined project teams to complete project tasks on-time, on-budget, meeting all requirements (quality, cost, schedule, scope).
• Developing and executing assigned project plans in accordance with the scope, schedule, quality, impact, and cost objectives.
• Managing, coordinating, and directing contract resources and internal resources.
• Refining and clarifying project scope through early project analysis with subject matter experts and owners to further substantiate project purpose.
• Monitoring and controlling project work with stringent follow-up on quality, schedule, and budget to ensure the project delivers the desired end-product.
• Monitoring and reporting project progress, communications to management and other stakeholders, and presentation in steering groups.
• Supporting building, managing, and improving Project Portfolio Management systems, ensuring alignment with global programs and other site projects to
• Supporting project team members mentoring and onboarding, following all safety and environmental requirements in the performance of duties, and fulfilling other accountabilities as assigned.
• Attend GMBR status update meetings, drive global action items, and participate in specialized topic discussions related to GMBR.
• Monitor and manage the implementation plan, ensuring adherence to schedule and effective communication with key stakeholders.

Qualifications:

• Minimum of five (5) years of proven project management experience required, to include:
• Leading change management projects required
• Leading complex & major capital expenditure projects required
• Minimum of one (1) year of experience in pharmaceutical or biotechnology environment preferred
• Availability to travel as needed and possess a valid visa/passport or be able to obtain one for potential international travel.
• Excellent writing & oral communication skills; presentation & facilitation skills; & negotiation & conflict resolution skills required
• Ability to work in both technical & non-technical areas preferred
• Ability to use creativity to resolve problems that arise during project execution preferred
• Knowledgeable in GMP concepts preferred
• Knowledge of Lean principles & how they apply in a manufacturing environment preferred
• Ability to create & manage work plans & detailed project schedules required
• Develops & maintains strong internal & external relationship required
• Proficient in basic computer skills including experience with Microsoft Office required
• Ability to function independently, as well as execution of good judgement in decision making & strong leadership skills required
• Meets objectives demonstrating strong change management skills required
• Proven project management experience with direct management of multiple projects simultaneously required
• Proven expertise in planning/organizing, managing execution & revising the work plan for cross functional project teams preferred