Project Manager, Global Lab Services

Our Work Matters
At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.
The Impact You Will Make
This is an exciting opportunity as a Project Manager, Global Lab Services at our Woodbury location. This role will manage projects from the point of customer engagement to final reporting and confirmation of invoicing. They will follow harmonized robust processes for growth in our global Analytical Services organization. The Project Management team will manage both internal and external customer projects and oversee end-to-end project/sample processes to ensure clear communication and meet time commitments.
Responsibilities

• Assist in development, execution and maintenance of global PM processes for harmonization and transparency of project and sample management
• Work with Stability team to follow stability processes for harmonization and transparency of project and sample management
• Provide direction, and oversight of future Project Coordinator for clear communication of project and sample activities
• Oversee and coordinate samples and projects in the lab management system (such as LIMS)
• Work with internal teams to support projects and align of business needs
• Work with the Business Development Group to support new projects, balancing customer needs and business objectives
• Responsible for the coordination, finalization and maintenance of a project ensuring that the functional work plans are both communicated and aligned to deliver the expectations of internal/external clients and address deliverables
• Deliver project activities in accordance with current Regulatory, GMP, business guidelines.
• Make timely decisions and resolve conflicts as well as raise issues to appropriate management level when needed to keep projects and activities moving forward
• Responsible for the financial aspects of projects after win. Articulate the financial status of the project and how it is performing against plan. Work with Client/Internal depts to approve changes to the approved project plan either through scheduled re-approval of project plan and/or through agreed change order process. Responsible to enter the details of project into the D365 at agreed upon rates and timing.
• Collaborate with Supply Chain to ensure forecast accuracy
• Responsible where the project may not be meeting timelines or client expectations, to work with the project team to agree on action plan to realign the project for success, including briefing internal management as well as external clients where applicable. Organize and manage formal technical reviews as required.
• Organize and manage project and technical meetings with the Client. Coordinate preparation of both project and technical information to the Client in accordance with the contract and agreed communication processes. Ensures meeting minutes are accurately documented, issued within agreed timelines and are approved.
• Responsible for the maintenance of project management documentation as appropriate, in accordance with current regulatory, GMP, business guidelines (e.g., NPI tools, Decision logs, Risk logs etc.). Actively seek opportunities to accelerate progress on project, appropriately consider associated risks and both develop and drive suitable mitigation strategies.
• Responsible to coordinate input of project resource demands into a lab scheduling system used to align resource allocation across the division. Collaborate with functional leaders on core team selection to ensure the required skill sets are provided to match the project needs.

Requirements:

• Graduate - Science or engineering based is preferred but not essential
• Formal Project Management Accreditation desired but not essential (PMP certification)
• Master’s Qualification – Science or engineering based is advantageous but not essential
• At least 5 years of experience in Project Management for contract lab, CDMO, Pharma or Med Device industry
• Knowledge/experience of pharmaceutical product development, from concept through to product launch
• Good Pharma and cGMP knowledge and experience of pharma product development from concept to submission
• Strong Industry knowledge and awareness, keeping relevant on drug delivery development and understanding who the competition are and what they offer

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California residents should review our Notice for California Employees and Applicants before applying.
The expected compensation range for this position represents a good faith estimate. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s relevant knowledge, training, skills, work location, and/or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, & Vision, Health Savings Accounts, Flexible Spending Accounts, Disability Benefits, Life Insurance, Voluntary Benefits, Paid Absences, and 401k Benefits, etc.).

Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

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