Principal Scientist/Senior Principal Scientist, Form Characterization

4 hours ago


Summit NJ United States Bristol-Myers Squibb Full time
Principal Scientist/Senior Principal Scientist, Form Characterization

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.

Business Unit and Team 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.

Position Summary

Materials 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.

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, etc.) 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.
#J-18808-Ljbffr

  • Summit, United States Bristol-Myers Squibb Full time

    Principal Scientist/Senior Principal Scientist, Form CharacterizationWorking 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...


  • Summit, United States Bristol Myers Squibb Full time

    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...


  • Summit, New Jersey, United States Bristol Myers Squibb Full time

    About UsBristol Myers Squibb is a world-class pharmaceutical company that transforms patients' lives with innovative therapies. Our Drug Product Development team is dedicated to creating cutting-edge drug products that improve patient outcomes.Job DescriptionWe are seeking a highly skilled Materials Scientist to join our team as a Principal Scientist/Senior...


  • Boulder, CO, United States SciPro Full time

    SciPro is excited to share an extraordinary opportunity with our key client in Colorado who is seeking a Principal Scientist, ADC/Antibody Characterization to join their innovative team.This is not just another role—our client is backed by a former C-Suite executive from one of the largest global software companies, and they are at the forefront of...


  • Boulder, CO, United States SciPro Full time

    SciPro is excited to share an extraordinary opportunity with our key client in Colorado who is seeking aPrincipal Scientist, ADC/Antibody Characterization to join their innovative team.This is not just another role—our client is backed by a former C-Suite executive from one of the largest global software companies, and they are at the forefront of...


  • Summit, United States Bristol Myers Squibb Full time

    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...


  • New Brunswick, NJ, United States Cfdv Full time

    Principal Scientist or Sr. Principal Scientist - Analytical Development Primary Location: New Brunswick, New Jersey or Summit, New Jersey We are seeking an experienced leader with strong analytical technical skills and a passion for strategic project leadership, mentoring others, and driving technical innovation to solve challenging problems. This role will...


  • Cambridge, MA, United States Apex Systems Full time

    Principal Scientist, Analytical Development Location : Cambridge, MA (Onsite)Science: Small Molecule Therapeutics Job Overview: The Principal Scientist in Analytical Development guides pharmaceutical advancements from inception through clinical stages and collaborates with internal and external partners. Primary Job Responsibilities: Develop specialized...


  • Plainfield, NJ, United States Kashiv Biosciences, LLC Full time

    Description The Senior/Principal Scientist will be part of the CMC ARD team responsible for drug product related CMC strategy development for clinical stage biosimilar and conjugate biologics programs. The individual will be proficient in multiple analytical techniques as well as with the latest ICH, FDA and EMA regulatory guidance on pharmaceutical...

  • Principal Scientist

    3 hours ago


    Bridgewater Township, NJ, United States Nestlé SA Full time

    Principal Innovation Sensory Insights Scientist At Nestlé Health Science, we believe that nutrition, science, and wellness must merge, not collide. Here, we embrace the intrinsic connections of these three pillars, harnessing their collective strength to empower healthier lives. Our broad product portfolio includes renowned brands like Garden of Life,...


  • Denver, CO, United States Altamira Technologies Corp. Full time

    Altamira Technologies is seeking a Principal AI Scientist that possesses a mix of talent related to artificial intelligence / machine learning, data science, and traditional algorithms. In response to emergent customer requirements, the Principal AI Scientist leverages their understanding of national security missions to develop innovative and viable...


  • San Diego, CA, United States Web-atrio Full time

    Principal Scientist, Fermentation Process Development Status: Archived Company: Tanvex Biopharma Location: (Insert Location) Expiration: 2023-08-01 How to Apply: Apply Here SUMMARY: The Principal Scientist will act as a primary driver in biologics manufacturing process optimization, scale-up, tech transfer, process characterization/validation, and...

  • Principal Scientist

    4 weeks ago


    Johns Creek, GA, United States Alcon Full time

    Are you ready to see your future like never before? If so, Alcon is the place for you! A career at Alcon is like no other. We are innovative. We are impactful. We are the largest eye care medical device company helping restore sight and allowing millions of people worldwide to see brilliantly. We have a long history of industry firsts and a diverse...

  • Principal Scientist

    4 weeks ago


    Johns Creek, GA, United States Alcon Full time

    Are you ready to see your future like never before? If so, Alcon is the place for you! A career at Alcon is like no other. We are innovative. We are impactful. We are the largest eye care medical device company helping restore sight and allowing millions of people worldwide to see brilliantly. We have a long history of industry firsts and a diverse...


  • Newton, MA, United States Energy Jobline AZ Full time

    Principal Scientist Summary: Principal Scientists direct or manage projects with potentially high stakes, requiring thoughtful application of the appropriate technical disciplines and professional judgment. They oversee the scope and quality of service delivery from the beginning to the end of a project, by ensuring that the team is aware of, and addresses...


  • Sunnyvale, CA, United States Amazon Full time

    Job ID: 2829026 | Amazon.com Services LLC As a Principal Scientist in Ring and Blink, you will have deep subject matter expertise in the areas of Artificial Intelligence. You will work with multiple teams of scientists and engineers to translate business and functional requirements into concrete deliverables. More specifically, you will provide thought...

  • Principal Scientist

    5 hours ago


    Greenville, NC, United States Catalent Pharma Solutions Full time

    time left to apply End Date: December 30, 2024 (30 days left to apply) job requisition id 0086811 Principal Scientist Position Summary Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging....

  • Principal Scientist

    5 hours ago


    San Diego, CA, United States Pfizer Full time

    Principal Scientist (PhD), Biophysics ROLE SUMMARY The Pfizer Oncology Research Unit in La Jolla is seeking an accomplished Principal Scientist to join the Biophysics & HTS group within Discovery Technologies. The successful candidate will evaluate drug interactions and protein behavior primarily using biophysical methods. In addition, the characterization...


  • St. Paul, MN, United States Abbott Laboratories Full time

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.Principal...


  • Richmond, VA, United States Capital One Full time

    Locations: VA - McLean, United States of America, McLean, Virginia Principal Data Scientist Principal Data Scientist – Consumer Credit Risk Management Models and Data Data is at the center of everything we do. As a startup, we disrupted the credit card industry by individually personalizing every credit card offer using statistical modeling and the...