Principal Scientist/Senior Principal Scientist, Sterile Product Development
Location
Jersey | United Kingdom
Job 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.
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 .
Drug Product Development (DPD) 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 This position will be part of Sterile Product Development within the Drug Product Development organization located at New Brunswick, NJ. We are seeking a collaborative, self-motivated, and results oriented scientist/engineer with a passion for problem-solving to extend and enhance patient lives, with a focus on formulation and process development.
The successful candidate excels in a collaborative, cross-functional, matrix team environment to enable the development of new injectable drug products for small molecules, biologics, and emerging modalities, including antibody-drug conjugates, gene therapy (viral vector), and nucleic acids with/without encapsulation technologies.
The successful candidate will be responsible for evaluation of novel drug delivery technologies to develop parenteral formulations for diverse therapeutic modalities. These novel drug delivery technologies include, but are not limited to, liquid crystals, PLGAs, and hydrogels. Experience in nanoparticulate systems is desirable. The successful candidate must demonstrate expertise in developing long acting injectables and extended-release formulations, with demonstrated record of nonclinical and clinical translation of these technologies. The candidate will be responsible for developing, characterizing, and testing of polymer or lipid-based formulations, including (but not limited to) liposomal systems. Experience in nanoparticulate systems is desirable. In addition to portfolio-wide contributions listed above, the successful candidate has training and experience in making and characterization of suspensions/emulsions, extended/controlled release and/or tissue targeting constructs, The scientist/engineer will design and execute studies to develop patient-centric parenteral dosage forms and their manufacturing processes to enable clinical and commercial use.
Responsibilities - Drive drug product development as a member/leader of multidisciplinary project teams in a matrix environment, striving towards objectives aligned with Drug Product Development goals.
- Proactively apply scientific or engineering expertise to develop solutions to complex technical, operational, and/or business problems which require ingenuity and creativity.
- Evaluate external drug delivery technologies, leveraging external consultants and internal SMEs, and establish new internal and external collaborations.
- Develop parenteral dosage forms for clinical and commercial use throughout various stages of development.
- Conduct process development, optimization and scale-up studies; bring this knowledge to project teams to enable successful drug product technology transfer to clinical manufacturing and commercial sites.
- Generate data and knowledge for regulatory filings through planning and execution of experimental plans with minimal supervision, within project timelines.
- Integrate and interpret research data and present conclusions as appropriate at various project meetings.
- Issue periodic reports and ensure compliance to safety rules and regulations, experimental best practices, electronic laboratory notebook, and other expectations and trainings based on corporate and regulatory guidelines.
- Participate on appropriate portfolio and strategy initiative teams.
- Maintain awareness of advances in drug product development science and technologies to evaluate innovative opportunities to enhance productivity and efficiency of workflows.
- Be an in-house expert in making and characterization of advanced formulation technologies that enable tissue-targeting and pharmacokinetics engineering (e.g. extended/controlled release, improved in vivo stability).
Qualifications - Ph.D. with 5+ years of experience or MS with 10+ years of experience (Principal Scientist) or Ph.D. with 8+ years of experience or MS with 13+ years of experience (Senior Principal Scientist) , with a degree in Pharmaceutics, Biochemistry, Chemistry, Pharmaceutical Chemistry, Molecular Biology, Bioengineering, Chemical Engineering, Materials Science & Engineering or related disciplines.
- Advanced knowledge and understanding of principles (scientific, engineering and quality by design principles, business processes) related to pharmaceutical drug product development of injectable dosage forms.
- Experience with in vitro-in vivo novel technology feasibility assessment.
- Hands-on experience with various biophysical, biochemical, or soft material characterization tools.
- Experience with process development (lyophilized or ready-to-use presentations) and scale-up of injectable dosage forms to clinical or commercial manufacturing sites.
- Ability to problem solve using scientific or engineering, techniques to support drug product development from early development through product launch as a member of a multidisciplinary project team.
- Experience in experimental design and execution as well as independent interpretation of data, generated by a wide variety of analytical characterization techniques, available from experiments designed by self or others.
- Comprehensive knowledge and understanding of solubility, phase-separation, colloidal stability, electrostatic and hydrophobic interactions; at a level that enables hypothesizing options for rational design/selection of excipients and formulation conditions (e.g. pH, ionic strength) to achieve directed self-assembly in complex mixtures.
- Understanding of pre-filled syringes, autoinjectors, and other devices options for use in patient-centric products.
- Excellent team player with good interpersonal, written, verbal communication skills.
- Capable of leading formulation and/or drug product matrix teams and influencing across interfaces.
- Ability to guide/lead successful completion of programs or initiatives.
- Hands-on computer skills and knowledge of statistics.
- Ability to learn new techniques and apply these to address cross-functional development challenges.
#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.
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
[email protected] . 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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