BExM Clinical Project Manager
Company: Bristol-Myers Squibb
Location: Devens, Massachusetts
Posted: May 05, 2017
Reference ID: 1701821
At Bristol-Myers Squibb, we believe that together we can make the difference. We want to do this by building professional teams who can create and innovate medicines that benefit doctors and their patients.
Our large-scale biologics manufacturing facility in Devens, Massachusetts, is expanding and there are a number of exciting career opportunities to join Bristol-Myers Squibb, one of the world’s leading BioPharma companies.
We’ve created one of the world’s premier biologics facilities, among the first sites in the industry to have a fully automated, integrated manufacturing control system that enables the plant to run virtually paperless. It is a site that combines biologics development with clinical and commercial manufacturing on a single campus – a true biologics center of excellence for the company where teams are encouraged to closely collaborate. This expansion was designed to support the launch of new medicines by more closely aligning biologics development and manufacturing capabilities. All this goes towards helping create and innovate life-saving medicines that fight serious illnesses.
This position will plan, monitor and execute Biologics External Manufacturing (BExM) Clinical outsourcing deliverables for outsourced manufacturing projects, including program planning, project management and Contract Manufacturing Organization (CMO) oversight. This position reports to a Supply Relationship Manager (SRM) and has no direct supervisory responsibilities. The position will be responsible for the strategic planning and execution of the Biologics External Manufacturing clinical outsourcing deliverables for one or more manufacturing projects, including delegated SRM responsibilities which include the oversight and management of all BMS business with one or more CMOs, responsibility for relationship management, contract monitoring and ensuring uninterrupted supply. The successful candidate will coordinate internal BMS project resources, vendor activities and maintain tracking metrics where applicable. The position will support generation of departmental policies, procedures, metrics and standards for managing clinical outsourcing. This role has significant interfaces within Biologics Development (BD), external vendors, and cross-functional teams (Process Development, Quality, Analytical, Procurement, Finance, and Supply Chain). The successful candidate will utilize project management competencies to support clinical outsourcing projects (e.g., design standard work, create templates, create tools, and build processes). This position can be located at a different BMS site- Devens MA, New Brunswick NJ, or our facility in Switzerland.
The position will:
• Be a Suppler Relationship Manager as delegated by the Director SRM for specified CMOs.
• Ensure the successful resolution of all issues that may impact timely supply of product and/or contractual obligations
• Develop, gain alignment for and implement project plans (e.g. activities, deliverables, timelines, resources, work assignments) that are aligned with the BExM/BD approved objectives and timelines with input from Integrated Development Team (IDT) Leads and functional managers.
• Be accountable for the performance of the assigned CMOs. Responsible for reviewing and communicating CMO performance metrics and the development of the improvement plans as warranted; appropriately escalate issues and risks to the project/technical team and stakeholders.
• Manage relationships and interactions with BExM vendors at the project level including: Develop, negotiate, review and gain approval of outsourced contracts and documents in partnership with Procurement.
• Coordinates the review and acceptance of vendor deliverables and approves vendor invoices for payment. Monitors spending vs. budget.
• Educate self and others about the clinical outsourcing capabilities of CMOs and core operational issues at CMO sites; proactively identifies supply risks and proposes strategies for approval and implementation to avoid or minimize their impacts.
• Identify and implement improvements within BMS and at CMOs.
• Develop self and others as appropriate
Specific Knowledge, Skills, Abilities:
• Work experience in cGMP Manufacturing, Technical Support or Process Development of processes for manufacturing of viruses and/or therapeutic proteins in mammalian and/or microbial systems is required. Knowledge of regulatory guidelines and requirements is a plus. Experience with viruses is highly desired.
• Excellent client-facing and internal communication skills as well as excellent written and verbal communication skills. Able to effectively transfer complex knowledge regarding science and engineering procedures.
• Solid organizational skills including attention to detail and ability to manage multiple projects
• Strong working knowledge of Microsoft Office software (Word, Excel, PowerPoint, MS Project, SharePoint, etc.)
• Proven working experience in project management in the biopharmaceutical/ biotech sector or related field preferred with understanding and/or hands-on experience in project management software and related tools.
• Successful track record in execution and completion of objectives.
• Ability to apply technical and cross-functional expertise to address complex operations problems. Demonstrated analytical and creative problem-solving skills.
• Ability to lead teams and to work effectively with cross-functional & multi-location teams
• Experience of a culturally diverse workplace through international projects or global teams is highly desired.
• Experience negotiating supply agreements with CMOs is a plus.
BS/MS/PhD in Engineering, Biology, Biochemistry and 5 years of relevant experience in the biopharmaceutical or related industry. 2 years project management experience strongly preferred. MBA, PMP, Project Management certifications are a plus.
Together, we make a difference. Bristol-Myers Squibb is one of the world’s BioPharma leaders, committed to delivering innovative medicines as well as nurturing a culture that’s a springboard for progress. Our success depends on building teams of bold, innovative and passionate employees who will help continue to drive us further forward. No matter the role, we are united by our mission and determined to win this fight. And that makes all the difference. If you want to join us, apply now at www.bms.com/careers .