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 ScientistDrug 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 investigations, interprets diverse data and/or results, and independently recommends next steps
• Leads multiple projects of moderate or high complexity within or across departments, and/or leads complex multi-site/function investigations if applicable
• Makes decisions that frequently require developing new options to solve complex problems. Decisions impact the ability of a work group/team or department to deliver on its objectives and meet the needs of stakeholders
• Regularly adapts standard methods and techniques. Plays a significant role in continuous improvement efforts within a department/function
• Highly proficient in writing formal reports/documents, technical presentations, articles for publication, and scientific publications or patents
• Actively mentors others to facilitate the growth of less experienced scientists. Emerging as a functional leader who influences culture and values

Qualifications & Experience:

• Bachelor's Degree in Industrial Pharmacy or Engineering (Chemical, Electrical, or Mechanical) with a minimum of eight (8) years of directly related experience in a Technical Services function within the pharmaceutical industry, including strong proven work experience in pharmaceutical Drug Product technology transfers, process development, and technical support. Note: Candidates with a Master's or Ph.D. degree in Pharmacy or Engineering will be considered with four to six (4 - 6) years of directly related experience in a Technical Services function within the Pharmaceutical industry, including strong proven work experience.
• Advanced knowledge of the principles and concepts applicable to a wide range of work in oral solid dosage processing, including the areas of formulation development, tech transfer, commercial manufacturing, and unit operations
• Detailed knowledge of OSD Drug Product process validation and cleaning validation
• Experienced with the use of statistical software to design DOEs and analyze process-related data
• Thorough knowledge of global regulatory requirements related to the design and control of pharmaceutical manufacturing processes
• Willing to travel frequently

Preferred Qualifications:

• Experience in working with OSD Drug Product continuous manufacturing and/or spray-dried dispersion

If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.
Uniquely Interesting Work, Life-changing Careers
With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in an inclusive culture, promoting diversity in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.
On-site Protocol
Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.
BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters.
BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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