Sanofi
Biopharmaceutics Principal Scientist
Sanofi, Cambridge, Massachusetts, us, 02140
Biopharmaceutics Principal Scientist
Location:
Cambridge, MATime Type:
Full timePosted On:
Posted 3 Days AgoJob Requisition ID:
R2760067About the JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Sanofi is seeking an experienced Biopharmaceutics Principal Scientist with self-motivation and enthusiasm to join the Biopharmaceutics group located in Cambridge, MA.As a Biopharmaceutics Scientist, you will play a pivotal role in conducting comprehensive evaluations of APIs and drug products, leveraging your Biopharmaceutics expertise and the latest in-vitro and modeling methodologies. You will collaborate across multiple teams, ensuring the assessment and mitigation of risks in developing oral drug products and manufacturing processes. Your responsibilities will include providing a holistic Biopharm Risk Evaluation (BRE), designing and generating critical in-vitro data, expanding Biopharmaceutics knowledge, authoring regulatory documentation, and driving innovation.Key RequirementsWe are looking for a candidate with a strong technical background and experience in Biopharmaceutics for oral drug product development for small molecule modality, and hands-on experience with in vitro dissolution experiments and modeling skills.In-depth knowledge of Pharmacokinetics and pre-formulation.Strong background in SUPAC, drafting regulatory communication, and biowaiver applications.Work LocationThis is an On-Site designated role with ad hoc flexibility in Cambridge, MA.Key Responsibilities:Develop and advance concepts of translational biopharmaceutics with a focus on improving predictive capabilities by linking in vitro drug product performance attributes to in vivo performance attributes.Assist in combining leading-edge in vitro and in silico capabilities with drug product design.Design and perform in vitro experiments to evaluate dissolution of drug products using an agile approach.Work closely with various groups to address the biopharmaceutics needs of oral, parenteral, transdermal, and other delivery routes.Demonstrated abilities to work in cross-disciplinary teams and ability to partner with cross-disciplinary subject matter experts in Pharmaceutical Sciences, Pharmacokinetics & Drug Metabolism and Clinical Pharmacology departments.About YouBasic QualificationsPh.D. in Physical Chemistry, Pharmaceutics, Biochemistry, or related discipline.5 years of relevant industry or academic experience.Experience with dissolution experiments using USPII, transfer and infusion methods.Experience in generating and interpreting experimental data; understanding of formulation development, pre-formulation studies.Experience with modeling and PK software, i.e., Matlab, R, Python, WinNonlin, NONMEM, Gastroplus, Simcyp or similar programs.Strong organizational and communication skills.Ability to prioritize and manage multiple projects and activities while meeting tight deadlines.Proactive in problem-solving and able to independently manage timelines and priorities.Preferred QualificationsHands-on with Pion systems and in situ UV probes.Hands-on experience with Gastroplus and/or Simcyp.Demonstrated experience/knowledge in the development of enabling formulations such as spray-dried amorphous dispersions, lipidic formulations, nano-crystal formulations.Experience running Pion, dissolution apparatus and HPLC systems.Experience in writing documents for regulatory submissions and responding to health authority questions.Why Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.Pursue
progress , discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com.Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
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Location:
Cambridge, MATime Type:
Full timePosted On:
Posted 3 Days AgoJob Requisition ID:
R2760067About the JobWe are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?Sanofi is seeking an experienced Biopharmaceutics Principal Scientist with self-motivation and enthusiasm to join the Biopharmaceutics group located in Cambridge, MA.As a Biopharmaceutics Scientist, you will play a pivotal role in conducting comprehensive evaluations of APIs and drug products, leveraging your Biopharmaceutics expertise and the latest in-vitro and modeling methodologies. You will collaborate across multiple teams, ensuring the assessment and mitigation of risks in developing oral drug products and manufacturing processes. Your responsibilities will include providing a holistic Biopharm Risk Evaluation (BRE), designing and generating critical in-vitro data, expanding Biopharmaceutics knowledge, authoring regulatory documentation, and driving innovation.Key RequirementsWe are looking for a candidate with a strong technical background and experience in Biopharmaceutics for oral drug product development for small molecule modality, and hands-on experience with in vitro dissolution experiments and modeling skills.In-depth knowledge of Pharmacokinetics and pre-formulation.Strong background in SUPAC, drafting regulatory communication, and biowaiver applications.Work LocationThis is an On-Site designated role with ad hoc flexibility in Cambridge, MA.Key Responsibilities:Develop and advance concepts of translational biopharmaceutics with a focus on improving predictive capabilities by linking in vitro drug product performance attributes to in vivo performance attributes.Assist in combining leading-edge in vitro and in silico capabilities with drug product design.Design and perform in vitro experiments to evaluate dissolution of drug products using an agile approach.Work closely with various groups to address the biopharmaceutics needs of oral, parenteral, transdermal, and other delivery routes.Demonstrated abilities to work in cross-disciplinary teams and ability to partner with cross-disciplinary subject matter experts in Pharmaceutical Sciences, Pharmacokinetics & Drug Metabolism and Clinical Pharmacology departments.About YouBasic QualificationsPh.D. in Physical Chemistry, Pharmaceutics, Biochemistry, or related discipline.5 years of relevant industry or academic experience.Experience with dissolution experiments using USPII, transfer and infusion methods.Experience in generating and interpreting experimental data; understanding of formulation development, pre-formulation studies.Experience with modeling and PK software, i.e., Matlab, R, Python, WinNonlin, NONMEM, Gastroplus, Simcyp or similar programs.Strong organizational and communication skills.Ability to prioritize and manage multiple projects and activities while meeting tight deadlines.Proactive in problem-solving and able to independently manage timelines and priorities.Preferred QualificationsHands-on with Pion systems and in situ UV probes.Hands-on experience with Gastroplus and/or Simcyp.Demonstrated experience/knowledge in the development of enabling formulations such as spray-dried amorphous dispersions, lipidic formulations, nano-crystal formulations.Experience running Pion, dissolution apparatus and HPLC systems.Experience in writing documents for regulatory submissions and responding to health authority questions.Why Choose Us?Bring the miracles of science to life alongside a supportive, future-focused team.Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally.Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.Pursue
progress , discover
extraordinary
Better is out there. Better medications, better outcomes, better science. But progress doesn’t happen without people – people from different backgrounds, in different locations, doing different roles, all united by one thing: a desire to make miracles happen. So, let’s be those people.At Sanofi, we provide equal opportunities to all regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, ability or gender identity.Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe. Discover more about us visiting www.sanofi.com.Why Sanofi
As an organization, we change the practice of medicine; reinvent the way we work; and enable people to be their best versions in career and life. We are constantly moving and growing, making sure our people grow with us. Our working environment helps us build a dynamic and inclusive workplace operating on trust and respect and allows employees to live the life they want to live.
#J-18808-Ljbffr