Principal Scientist, Drug Product Development to Launch, Pharma MS&T

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.

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. Read more: careers.bms.com/working-with-us.

The Pharma Manufacturing Science & Technology organization works to launch and supply new Pharma Medicines through their lifecycles. We are working with internal engine of invention on small molecule starting materials, drug products, and finished goods across many therapeutic modalities to enable reliable, cost-effective supply to patients. We work on a global scale with colleagues across the organization to provide scientific expertise and technical support for manufacturing of Pharma products. Here, you’ll pursue innovative ideas, and advance professionally alongside some of the brightest minds in Pharma.

The Principal Scientist Drug Product (DP) Development to Launch (DtL) will provide technical leadership and will have technical accountability for oral solid dosage (OSD) drug products transitioning from development to commercial launch.  This includes participating in development teams for late-phase assets, commercial site selection, design and evaluation of tech transfer studies, generation and execution of process performance qualification (PPQ) studies, and writing/reviewing pertinent sections of regulatory dossiers. 

• Work with the drug product development team and manufacturing site technical leads to develop and communicate a tech transfer plan

• Act as the technical lead and/or project lead in tech transfer or other technical projects

• Ensure a high level of current technical knowledge is maintained within the MS&T group

• Serve as a technical expert in at least one relevant drug product manufacturing unit operation

• Provide leadership support and technical consultation to Pharma MS&T DP DtL Lead

• Lead teams of MS&T Managers where required

Responsibilities:

• Maintain technical leadership in manufacturing sciences in the areas of raw material characterization, formulation science, oral solid dosage processing, and other relevant drug product manufacturing technologies. 

• Serve as the Pharma Manufacturing Science & Technology (PMS&T) DP representative on OSD drug product development to launch teams directing all tech transfer-related activities from and to all BMS and CMO manufacturing sites.

• Participate or lead sourcing due diligence, process fit/gap assessment between sending and receiving sites, tech transfer planning, setting specifications, creating robustness space, development risk assessments, writing sections for regulatory filings, and process and cleaning validation strategies. 

• Provide on-site support for tech transfer and PPQ activities.

• Collaborate with API teams to align requirements to ensure the delivery of a robust DP manufacturing process. 

• Perform risk assessments to evaluate the probability and impact of risks. 

• Provide input and maintain the product risk registers, establish mitigation strategies to reduce or eliminate risk. 

• Ensure QbD principles are followed during development and tech transfer. 

• Make certain key and critical process parameters are identified and appropriate robustness monitoring programs and controls are in place.

• Monitor DP performance with respect to changes in material properties or processes.

• Initiate and/or assess change controls associated with introducing new products to site and changes associated with process after PPQ is complete. 

• Provide input as a technical leader on manufacturing processes and applicable technology platforms to other teams. 

• As needed, lead or support significant technical investigations at manufacturing sites. 

• Provide technical expertise to troubleshoot product/process issues.

• Designs complex technical projects or inves