Associate Manager, Biologics Analytical CRO Operations
Company: Bristol-Myers Squibb Company
Location: New Brunswick
Posted on: February 9, 2020
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
Biologics Development and Manufacturing Sciences and Technologies
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, 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:
- Liaise between development scientists and contract research
organizations (CROs) and coordinates project work at CROs.
- Facilitates project progress meetings with CROs, perform issue
resolution and escalations and complete project close out
- Reviews project needs, estimate funds, facilitates SOWs and
POs, and manages invoices.
- Manages the maintenance of the outsourced book-of-work database
for select strategic partners.
- Ensures that CROs follow applicable SOPs and Quality
- Supports Suppliers Relationship Management (negotiate pricing,
contracting, metrics tracking).
- Ensures compliance with and maintains required training in
relevant BMS and departmental GMP, GLP, SOP, safety and other
- Bachelor's degree in Biology, Biotechnology, Chemistry or
related discipline with minimum 5 years of experience within the
pharmaceutical industry and with a focus in the area of CMC
development of Biologics compounds.
- Candidates who possess 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, and communication planning and
- 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.
Keywords: Bristol-Myers Squibb Company, New Brunswick , Associate Manager, Biologics Analytical CRO Operations, Executive , New Brunswick, New Jersey
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