Bristol Myers Squibb Manager, External Analytical Strategy & Management in New Brunswick, New Jersey
This role will support the Product Development (Small Molecule) area core functions with the planning, creation and execution of CMC development projects with external parties under the sponsorship of ASO. The position will require extensive interfacing with inter disciplinary scientific staff, RD Quality, Strategic Partner Management, Global Procurement, Finance, Legal, Portfolio Strategy & Integration and other functional areas. 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.
Monitoring of external project activities, facilitating and/or lead project progress meetings with CROs, perform issue resolution and escalations, and complete project close out activities.
Establishes and maintains relationships with CROs, coordinates project work, collaborates with Global Procurement to support SRM (negotiate pricing, contracting, track KPIs).
Perform situational appraisals, investigations, and recommend CAPAs of applicable Quality Events originating in CROs. Initiates CRO investigations on behalf of ASO.
Ensures that CROs follow applicable SOPs and Quality Agreements, evaluates CROs through onsite visits, and can assist/shadow in technical audits of CROs.
Liaise between development scientists and contract research organizations (CROs).
Manage budgets related to external projects (through SAP, PSI, and other tools) and provide updates to ASO, PD Management, GP, and Finance as needed.
Reviews project needs; estimates resources, funds and facilities need for external work. Make recommendations when appropriate to move external work to internally supported work streams within ASO or other collaborators.
Manage internal staff as needed.
Ensures compliance with and maintains required training in relevant BMS and departmental GMP. GLP, SOP, safety and other guidelines.
Travel would be required (5%).
• Bachelor’s degree (advanced degree preferred) in Chemistry, Biology, Biotechnology, or related discipline with 7 or more years of experience within the pharmaceutical industry, and with a focus in the area of CMC development of synthetic compounds.
• Candidates who possess or are pursuing an advanced degree or a business degree would be preferred.
• Experience in managing CRO/CTO’s, primarily in the area of analytical support is required.
• Understanding and experience of the drug development process and associated regulatory framework is essential.
• Thorough understanding of cGMP’s is strongly preferred
• Must be able to work across and influence multi-departmental initiatives, work independently, and with minimal supervision.
• Working knowledge of project management skills such as facilitation, planning, financial analysis, budgeting, change management, stakeholder alignment, communication planning and results delivery
• Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, Access) and business systems such as SAP/Ariba are essential.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled