Principal Scientist/Senior Principal Scientist, Form Characterization

Company: Disability Solutions
Location: New Brunswick
Posted on: November 4, 2024

Job Description:

Working with UsChallenging. 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: .Business Unit and Team SummaryOur 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 SummaryMaterials Science & Engineering (MSE) in Drug Product Development (DPD) plays an integral role in the development and characterization of powder materials used in various applications and building robust form and powder property control strategies of the active pharmaceutical ingredient (API) in the drug product.The Form Characterization Principal Scientist/Senior Principal Scientist will be responsible for solid state characterization throughout all stages of development (from discovery to commercialization). Primary activities will include characterization of materials properties such as form/polymorph and melting/glass transition, as well as method development, validation, and transfer. It is expected that the candidate will work with a broad range of materials, including crystalline and non-crystalline small molecule APIs, drug product intermediates, drug products and excipients, and biologics.The scientist should work independently to carry out laboratory based de novo analytical methods development, chemical characterization studies and chemical stability characterization evaluations. Where required, activities will be performed in accordance with cGLP/cGMP regulations, established business processes and protocols, and applicable standard operating procedures. Strong communication, interpersonal and leadership skills are key since the scientist will operate within cross-functional teams.Key job responsibilities

• Support drug substance process development including characterization of starting materials, intermediates and final API.
• Support drug product formulation and process development including characterization of the process and finished product.
• Develop, optimize, validate and transfer analytical methods.
• Provide leadership and supervision to scientific staff. Develop, coach and mentor others.
• Serve on and lead departmental, interdepartmental and project teams.
• Report and discuss analytical results and conclusions both orally and in writing.
• Write formal reports for inclusion in regulatory filings and support the generation of appropriate responses to questions from regulatory authorities.
• Review analytical data for completeness and correctness.
• Contributes to the ownership and advancement of lab instrumentation, work processes, and procedures.
• Collaborate with external partners, such as vendors and academic institutions, to leverage their expertise and resources for solid state characterization.
• Maintain a safe and organized laboratory environment, adhering to all relevant safety protocols and guidelinesRequirements
  • (Principal Scientist) Ph.D. in physical chemistry, materials or pharmaceutical science, chemical engineering, or related discipline, with 4-6 years, MS with 6-9 years or BS with 9-12 years of pharmaceutical/chemical industry or related experience.
  • (Senior Principal Scientist) Ph.D. in physical chemistry, materials or pharmaceutical science, chemical engineering, or related discipline, with 6-9 years, MS with 9- 12 years or BS with 12-15 years of pharmaceutical/chemical industry or related experience.
  • In-depth knowledge of small molecule form/salt characterization and selection techniques (such as vibrational spectroscopy, crystallography, SSNMR, vapor sorption, XRD, TGA, DSC, ...) and processes.
  • In-depth knowledge of vibrational spectroscopy and its application for form characterization is a strong plus.
  • Hands on experience with form screening and characterization
  • Hands on experience with method development, validation and transfer.
  • Hands-on and theoretical knowledge of crystal structure determination is a plus.
  • Experience with working with CROs.
  • Hands-on experience in participating and leading cross-functional teams. Knowledge and experience in linking API and excipient properties to drug product performance.
  • Knowledge of other solid state characterization techniques (such as particle size and shape, surface area and energetics, porosimetry, rheology etc.) is a plus
  • Understands and applies Quality by Design principles when required
  • Strong statistical knowledge and experimental design capabilities.
  • Ability to adapt to changing priorities and work in a fast-paced environment
  • Strong verbal and written communication skills and interpersonal skills as a team member/leader in an environment where individual initiative, collaboration and accountability are valued.
  • A demonstrated record of scientific accomplishment, laboratory experimentation, publication and presentation.
  • Strong problem-solving and troubleshooting skills.
  • This position requires employees to work with or come in contact with chemical agents which may pose health or safety hazards if improperly handled. 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 CareersWith 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 BMS has a diverse 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 jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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 . Visit 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.If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Keywords: Disability Solutions, Fairfield , Principal Scientist/Senior Principal Scientist, Form Characterization, Other , New Brunswick, Connecticut