Senior Manager, Biologics Analytical CRO Operations
Company: Bristol Myers Squibb
Location: New Brunswick
Posted on: January 8, 2021
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 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 are established
to drive outsourced project planning and execution:
- Scope of work (Defining milestones, deliverables and timelines
in collaboration with functional area SME's)
- Development and execution of associated contracts in accordance
with corporate policies
- Project start-up (establishment of key contacts, communication
plan, project kick-off meetings, etc.)Outsourcing oversight
- 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, collaborates 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 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%).Requirements:
- 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 of Biologics compounds.
- Strong verbal and written communication skills
- Experience in managing CRO/CTOs, primarily in the area of
- Ability to build strong working relationships with internal and
external partners, work well with matrix teams and effectively
manage activities across a complex portfolio of projects with
minimal supervision and a high sense of urgency.
- Understanding the drug development process and associated
regulatory framework is essential.
- Ability 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.Ideal Candidates Would Also Have:
- Candidates who possess or are pursuing an advanced degree or a
- 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.BMSBLAround 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
Keywords: Bristol Myers Squibb, New Brunswick , Senior Manager, Biologics Analytical CRO Operations, Executive , New Brunswick, New Jersey
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