Kindeva Drug Delivery
Project Manager, Global Lab Services
Kindeva Drug Delivery, Woodbury, Minnesota, United States,
Kindeva Drug Delivery
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
The Project Manager, Global Lab Services is a key role in the Global Lab Services Organization under the Analytical Services business unit. 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. This role requires partnering with internal clients and cross functional partners across the Kindeva enterprise as well as working with Business Development to support contract services.
This role will report to the Director, Global Project Management.
Essential Job Functions:
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.
Responsible for a certain percentage of annual revenue for external projects and cost allocation for internal projects
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.
Other responsibilities as assigned
Requirements:
Education requirements:
Bachelor's degree required Graduate or master's Qualification- Science or engineering based is preferred but not essential Formal Project Management Accreditation desired but not essential (PMP certification) Prior Employment Experience:
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 Cross functional team leadership experience Systems Experience:
Familiarity with LIMS and LMS
Other Skills required: (computer, language, etc.)
Microsoft Office Suite including Project and Visio, strong communication and presentation skills
#LI-On-Site
California residents should review our
Notice for California Employees and Applicants
before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
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.
Other details
Job Family Senior Management I Job Function Management Pay Type Salary
Apply Now
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
The Project Manager, Global Lab Services is a key role in the Global Lab Services Organization under the Analytical Services business unit. 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. This role requires partnering with internal clients and cross functional partners across the Kindeva enterprise as well as working with Business Development to support contract services.
This role will report to the Director, Global Project Management.
Essential Job Functions:
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.
Responsible for a certain percentage of annual revenue for external projects and cost allocation for internal projects
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.
Other responsibilities as assigned
Requirements:
Education requirements:
Bachelor's degree required Graduate or master's Qualification- Science or engineering based is preferred but not essential Formal Project Management Accreditation desired but not essential (PMP certification) Prior Employment Experience:
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 Cross functional team leadership experience Systems Experience:
Familiarity with LIMS and LMS
Other Skills required: (computer, language, etc.)
Microsoft Office Suite including Project and Visio, strong communication and presentation skills
#LI-On-Site
California residents should review our
Notice for California Employees and Applicants
before applying.
Covid-19:
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
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.
Other details
Job Family Senior Management I Job Function Management Pay Type Salary
Apply Now