Scientific Associate Director - New Brunswick, United States - Bristol-Myers Squibb

Bristol-Myers Squibb

Verified Company

New Brunswick, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Working with Us
Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department.

From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it.

You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams rich in diversity.

Take your career farther than you thought possible.

Our Analytical Strategy and Operations team creates transformative medicines of tomorrow based on the cutting-edge science of today.

Working within Global Product Development and Supply this team uses state-of-the art technologies to develop, enable and execute analytical and CMC strategies that ensure safety, quality and efficacy of life-saving medicines administered to patients in clinical studies.

Our team is involved at the earliest stages of Pharmaceutical and Biopharmaceutical product development through the successful commercial launch.

As a member of our team, you will get the chance to play a pivotal role to positively impact patients' lives while developing professionally to achieve your own career goals.

Job Title**:
Scientific Associate Director

Location:
New Brunswick

Division:
Global Production & Supply/Pharmaceutical Development/Analytical Strategy & Operations

Position Summary

This position will support the harmonization of microbiological testing for the Clinical Supply organization in New Brunswick, as well as the BMS network of microbiologists, in support of global Environmental, Sustainability and Governance (ESG) goals.

Supported methods will include all aspects of aseptic drug product processing, including small molecules, biologics and cell therapy. The position also provides compliance information for inspection readiness at all microbiological testing locations in the BMS network.

The Scientific Associate Director will also ensure appropriate strategies for DP-related manufacturing activities and will write or review microbiological sections of regulatory filings in compliance with current global expectations.

This position is a combination of office based and laboratory-based work, and includes data analysis and experimental design, as well as network microbiological support for new and existing products within BMS.

Direct Reports &
Indirect Reports Business Partners
This position will not have formal direct reports. Position will be supported by Assistant and Associate Research Scientists within the Microbiology Center of Excellence as indirect reports. Business partners are BMS site-based QC Microbiology Laboratories, Manufacturing Science & Technology/Process Microbiology and Manufacturing Science & Technology /Parenterals.

Role & Responsibilities**:

Provide specific strategic microbiology support to alternative methods in support of company ESG goals.
Participation in site assessments/vendor selection for CMOs/vendor with Procurement, MS&T, Quality, and other business functions. May act as SME on Quality audit team for External manufacturing sites.
Involved in troubleshooting issues and ensures that testing performed by external contract laboratories is technically sound and in compliance with BMS corporate, regulatory, quality and compliance expectations and requirements.
Ensures inspection readiness of the Microbiology Operations laboratory in New Brunswick and globally for QC microbiology laboratories in the network.
Supports the investigation and implementation of new technologies and methods for microbiological assays.
Support complex investigations involving microbiological assays or issues, including generation of CAPAs and change controls.
Provides support for the preparation, review and approval of microbiological methods and validation sections of regulatory filings, as well as responses to regulatory agency questions regarding sterile drug products produced by aseptic processing.
Provides dedicated support and access to expertise for customers within the Manufacturing Science & Technology Parenteral manufacturing department, by regular communication with department members.
Participate in internal and external industry forums to understand evolving regulatory expectations and industry best practices.
Travel to other sites or educational conferences will be required (20%).

Experience & Qualifications:

Bachelor's or advanced degree in Microbiology, Molecular Biology, Virology, or Biology/Biological Sciences.
Experience (15+yrs) in pharmaceutical microbiology
Advanced experience in pharmaceutical microbiology
Advanced knowledge of regulations for pharmaceutical and biopharmaceutical drugs, including specific review or preparation of INDs, BLAs, NDAs, ANDAs or supplements.
Motivated, adaptable, and re