Senior Manager, Biologics Analytical CRO Operations (R1551614-en-us)
At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.
This role will support Biologics Development Clinical & Commercial organizations with the planning, creation and execution of analytical testing with external parties under the sponsorship of ASO. The position will require extensive interfacing with inter disciplinary scientific staff, Quality, Strategic Sourcing & Procurement, Finance, Legal and other functional areas. This role provides an excellent opportunity to utilize both a scientific and project management 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 contract research organizations (CROs), perform issue resolution and escalations and complete project close out activities
- Manages the maintenance of the outsourced book-of-work database for select strategic partners.
- Liaise with commercial colleagues and CROs to coordinate project work.
- Maintains relationships with CROs, collaborates with Strategic Sourcing & Procurement to support SRM (negotiate pricing, contracting, metrics tracking).
- Reviews project needs; estimates resources, funds and facilitates need for external work. Make recommendations when appropriate to move external work to internally supported work streams within the BMS network.
- Ensures that CROs follow applicable SOPs and Quality Agreements, evaluates CROs through onsite visits and can assist/shadow in technical audits of CROs.
- Manage internal staff as needed.
- Ensures compliance with and maintains required training in relevant BMS and departmental GMP, SOP, safety and other guidelines.
- Travel would be required (~5%).
- Bachelor’s degree in Biology, Biotechnology, Chemistry or related discipline with 7 or more years of experience within the pharmaceutical industry and with a focus in the area of Commercial testing of Biologics compounds.
- Candidates who possess or are pursuing an advanced degree or a business degree would be preferred.
- Strong verbal and written communication skills, including the ability to communicate at all levels with clarity and precision.
- Experience in managing CRO/CTOs, primarily in the area of analytical support is required.
- Understanding the experience of the drug development process and associated regulatory framework is essential.
- 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.
- Thorough understanding of cGMP’s is strongly preferred.
- Proficiency with MS Office (Outlook, Word, Excel, PowerPoint, OneNote) and business systems such as SAP/Ariba are essential.
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
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 with the resources to pursue their goals, both at work and in their personal lives.
Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.
To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.
Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to firstname.lastname@example.org. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
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