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1010 Celgene - Summit (Corp)

Principal Scientist, Oral Product Development

1010 Celgene - Summit (Corp), New Brunswick, New Jersey, us, 08933

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Overview

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. 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. Care options and resources are described on the company careers site. Business Unit Summary

Our Drug Product Development team is committed to CMC design, development, and commercialization of innovative drug products to improve patient lives. We leverage the best people, collaboration, and cutting-edge innovation to achieve this commitment. BMS’s internal engine of innovation includes unrivaled industry leading expertise in CMC development of small molecules, protein biotherapeutics, protein degraders, and other therapeutic modalities. We collaborate closely with our colleagues in R&D and Commercial to design our drug products. Here, you’ll get the chance to grow and thrive through opportunities that are uncommon in scale and scope. Position Summary

Bristol Myers Squibb is seeking a principal scientist to join the Oral Product Development group within the Drug Product Development function. The drug product development group supports the formulation and process development of Bristol Myers Squibb’s drug candidates from preclinical stage to commercial process readiness. This position is responsible for formulation design, development, characterization, and technology transfer to enable development of small molecule drug products (DPs). The incumbent will be accountable as an individual contributor and as a formulation matrix team lead to support formulation development as well as providing necessary guidance and support of drug product control strategy for drug candidates across all stages of development. Key Responsibilities

The Principal Scientist will collaborate across BMS sites with Drug Product, Analytical, API, Quality, and Regulatory functions to execute drug product formulation/process development, formulation strategies, control strategies, and support of drug application submissions and approval. Key member of a dynamic scientifically driven team, dedicated to the design, development, and characterization of robust small molecule drug product formulations. Develop oral formulations for clinical studies and commercialization. Lead drug product formulation and process development including evaluating the need and potential for enhancing oral bioavailability, stability, and processability of drug candidates through appropriate formulation strategies. Support preparation of CMC regulatory documents. Support departmental initiatives for assigned projects and methodologies. Maintain safety, regulatory, and compliance standards as they relate to the development of pharmaceuticals. Prepare technical reports, batch records, SOPs, publications, and oral presentations as required. Collaborate with cross-functional team members to develop and optimize formulations and enable technology transfer to CMOs and other sites for manufacturing and scale up activities. Develop, coach and mentor others. Qualifications & Experience

Required: Completed BS and minimum of 9 years; MS and minimum of 6 years; or Ph.D. and minimum of 4 years in Pharmaceutical Science, Chemical Engineering or related discipline with pharmaceutical development experience. Experienced in formulation development, pharmaceutical processing related to drug product development and hands on experience. Strong understanding of drug substance, excipients, pharmaceutical unit operations (blending, milling, sieving, granulation, tableting, encapsulation, coating, spray drying), intermediate and critical quality attributes, statistics, risk assessment approaches, and cGMP principles. Experienced in building the CMC dossier for regulatory submissions within the development section as an author/reviewer. Basic knowledge of regulatory requirements. Demonstrated problem-solving and troubleshooting skills. Strong capabilities in experimental design and execution. Ability to work independently. Ability to provide leadership, guidance, and training to others within the department. Strong verbal and written communication skills. Strong interpersonal skills and the ability and interest to serve as a team member/leader in an environment where individual initiative, collaboration, and accountability are valued. Organizational and interdepartmental responsibilities with regards to leading workgroups, cross-functional teams, strategy development/ implementation/execution, and cultural initiatives. Additional notes: GPS_2025; LI_Onsite. 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. Compensation & Benefits

New Brunswick - NJ - US: $138,190 - $167,457. The starting compensation range(s) for this role are listed above for a full-time employee basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. Benefits may include Medical, pharmacy, dental, vision, wellbeing programs, 401(k), life and disability insurance, travel protection, paid holidays, vacation, volunteer days, sick time, parental and caregiver leave, adoption and surrogacy reimbursement, fertility benefits, and other programs. 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 talents and perspectives in a supportive culture, promoting global participation 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

BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design roles. The occupancy type is determined by the nature and responsibilities of your role. Site-essential roles require 100% of shifts onsite. Site-by-design roles may be eligible for a hybrid model with at least 50% onsite. Field-based and remote-by-design roles require the ability to travel and attend meetings as an essential job function. BMS provides accommodations for applicants with disabilities and directs inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility for the Equal Employment Opportunity statement. BMS recommends vaccination and boosters as part of well-being. Employment is considered for qualified applicants with arrest and conviction records as allowed by law. If you live in or work from Los Angeles County, please review California residents information at careers.bms.com/california-residents/. Any data processed in relation to role applications will be treated in accordance with applicable data privacy policies and regulations.

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