Senior Scientist Biopharmaceutics

About the Job

We 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 Requirements

• We 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 location 

• This 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 you

Basic Qualifications

• Ph.D. in Physical Chemistry, Pharmaceutics, Biochemistry, or related discipline

• 1-3 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 be able to independently manage timelines and priorities.

Preferred Qualifications

• Hands-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.

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