PROJECT MANAGER, BIOLOGIC DEVELOPMENT OUTSOURCING
Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
This newly created role will support the Biologics Development and Manufacturing Sciences and Technologies core functions with the planning, development and execution of CMC development projects with external parties.
The position will require extensive interfacing with inter disciplinary scientific staff, as well as with staff from Program Management, Quality, Global Procurement, Finance and Legal.
This role provides an excellent opportunity to utilize both a scientific and business background to contribute to the advancement of our growing and exciting portfolio of biologics.
Responsibilities are established to drive outsourced project planning and execution including:
Scope of work (Defining milestones, deliverables and timelines in collaboration with functional area SME's)Development and execution of associated contracts in accordance with corporate policiesProject start-up (establishment of key contacts, communication plan, project kick-off meetings, etc.
)Outsourcing oversight including:
Monitoring of project tasks per SOW'sFacilitating and/or participating in project progress meetingsTracking project milestones, deliverables and costPreparing study change orders and assessment of budget impact of changesAssisting functional area SME's with outsourced study related investigationsIssue resolution and escalationProject close out activities including:
Reconciliation to ensure that all rights and obligations under contract are metConduct lessons learned and supplier feedbackContribute to the preparation of the outsourced project budget and periodic projectionsAssist in the maintenance of the outsourced book-of-work database, budget tracking tools and contribute to CI efforts to enhance business analyticsCollaborate with Global Procurement in developing RFI/RFP's and to support SRM Qualifications Minimum
Qualifications:
Bachelor's degree (advanced degree preferred) in Biology, Biotechnology, Chemistry or related discipline with 5 or more years experience within the biopharmaceutical industry, specifically in the area of CMC development of mammalian derived biologics Preference will be given to those candidates who also possess or are pursuing a business degreeExperience in managing CRO/CTO's, primarily in the area of analytical support of biologics, is requiredGeneral understanding of the drug development process and associated regulatory framework is essentialThorough understanding cGMP's is strongly preferredMust be able to work independently, with minimal supervision Working knowledge of project management skills such as facilitation, planning, financial analysis, change management, stakeholder alignment, communication planning and results deliveryProficiency with MS Office (Outlook, Word, Excel, PowerPoint, Access) and business systems such as SAP/Ariba are essential Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501716.
Estimated Salary: $20 to $28 per hour based on qualifications.
One shared journey is moving us forward at Bristol-Myers Squibb.
Around the world, we are passionate about making an impact on the lives of patients with serious disease.
Empowered to apply our individual talents and ideas so that we can learn and grow together.
And driven to make a difference, from innovative research to hands-on community support.
Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment.
We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.
This newly created role will support the Biologics Development and Manufacturing Sciences and Technologies core functions with the planning, development and execution of CMC development projects with external parties.
The position will require extensive interfacing with inter disciplinary scientific staff, as well as with staff from Program Management, Quality, Global Procurement, Finance and Legal.
This role provides an excellent opportunity to utilize both a scientific and business background to contribute to the advancement of our growing and exciting portfolio of biologics.
Responsibilities are established to drive outsourced project planning and execution including:
Scope of work (Defining milestones, deliverables and timelines in collaboration with functional area SME's)Development and execution of associated contracts in accordance with corporate policiesProject start-up (establishment of key contacts, communication plan, project kick-off meetings, etc.
)Outsourcing oversight including:
Monitoring of project tasks per SOW'sFacilitating and/or participating in project progress meetingsTracking project milestones, deliverables and costPreparing study change orders and assessment of budget impact of changesAssisting functional area SME's with outsourced study related investigationsIssue resolution and escalationProject close out activities including:
Reconciliation to ensure that all rights and obligations under contract are metConduct lessons learned and supplier feedbackContribute to the preparation of the outsourced project budget and periodic projectionsAssist in the maintenance of the outsourced book-of-work database, budget tracking tools and contribute to CI efforts to enhance business analyticsCollaborate with Global Procurement in developing RFI/RFP's and to support SRM Qualifications Minimum
Qualifications:
Bachelor's degree (advanced degree preferred) in Biology, Biotechnology, Chemistry or related discipline with 5 or more years experience within the biopharmaceutical industry, specifically in the area of CMC development of mammalian derived biologics Preference will be given to those candidates who also possess or are pursuing a business degreeExperience in managing CRO/CTO's, primarily in the area of analytical support of biologics, is requiredGeneral understanding of the drug development process and associated regulatory framework is essentialThorough understanding cGMP's is strongly preferredMust be able to work independently, with minimal supervision Working knowledge of project management skills such as facilitation, planning, financial analysis, change management, stakeholder alignment, communication planning and results deliveryProficiency with MS Office (Outlook, Word, Excel, PowerPoint, Access) and business systems such as SAP/Ariba are essential Bristol-Myers Squibb is an equal opportunity employer - M/F/Vet/DisabilityRequisition ID - 1501716.
Estimated Salary: $20 to $28 per hour based on qualifications.
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