Analytical Outsourcing Manager EASM

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This role will support the Pharmaceutical Development area core functions with the planning, creation and execution of CMC development projects with external parties under the sponsorship of Analytical Strategy & Operations (ASO). The position will interface extensively with inter disciplinary scientific staff, Quality, Global 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.

Responsibilities include:


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.

Establishes and maintains relationships with CROs, coordinates project work, lead collaborations with Global Procurement to support SRM (negotiate pricing, contracting, metrics tracking).

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 CROs.

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 ASO or other analytical collaborators.

Manage external budget projections, spend tracking, and select value propositions.

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%).


Qualifications:


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 CMC development novel drug candidates.

Candidates who possess or are pursuing an advanced degree or a business degree would be preferred.

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.

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, OneNote) and business systems such as SAP/Ariba are essential.

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.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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