Bristol Myers Squibb
Principal Scientist/Senior Principal Scientist, Form Characterization
Bristol Myers Squibb, Summit, New Jersey, us, 07902
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.
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.
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.Contribute 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 guidelines.Requirements
(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.
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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.
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.Contribute 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 guidelines.Requirements
(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.
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