Bristol Myers Squibb Company

GxP Lab Manager, Materials Science & Engineering

Location
New Brunswick, NJ, United States
Posted
Aug 24, 2020
Ref
R1527938
Required Education
Doctorate/PHD/MD
Position Type
Full time
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 position sits within the Materials Science & Engineering group of Drug Product Development, and the successful candidate will be oversee the GMP workflows for release and stability of API samples for form and particle size.

Responsibilities:

Include coordinating GMP work with vendors including preparing statements of work, method qualification/validation and reviewing and approving method documents. The candidate will be expected to coordinate and execute internal API sample work, be responsible for GMP instrument maintenance, and be responsible to ensure GMP training is compliant and up-to-date. The candidate is expected to interface with cross-functional compliance teams to ensure the implementation of evolving quality system requirements, participate in inspections/audits, review/approve SOPs, and execute CAPAs

The successful candidate will work closely with characterization development colleagues to identify GMP needs and ensure smooth transition of methods to support release and stability work with vendors.

Requirements:

Ph.D. in analytical chemistry, chemistry, chemical engineering, materials engineering or related discipline with 3-5 years of pharmaceutical/ chemical industry experience or a BS/MS with 7-10 years of pharmaceutical/chemical industry experience. Excellent problem solving skills with a deep understanding and experience with GMP processes and systems. Experience in working with XRD and particle size analytical equipment and methods is desired.

The individual will effectively interface and collaborate across organizational boundaries including drug substance, drug product, analytical and quality teams. The individual must have demonstrated ability to identify and solve problems. Outstanding oral and written communication skills with the ability to provide technical input and scientific leadership are required.

Experience and knowledge in managing change controls (e.g. instruments, labs, methods) and deviations is desired. This position requires employees to work with or come in contact with chemical agents which may pose health or safety hazards if improperly handled.

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.