Principal Scientist, Oral Formulation (Biopharmaceutics and Predictive Dissolution)
- Cambridge, MA
- Permanent
- Full-time
As a Principal Scientist specializing in Oral Formulation (Biopharmaceutics and Predictive Dissolution), you will play a pivotal role in advancing drug development strategies within the Oral Formulation team. This Associate Director role will report to the Head of Oral Formulation, and will lead efforts in predictive dissolution, physiologically based pharmacokinetic (PBPK) modeling, and biopharmaceutics to optimize oral drug delivery systems. With responsibility for up to six drug products in various stages of development, you will design and implement innovative dissolution experiments, analyze clinical data, and provide scientific leadership to a team of skilled scientists. Your expertise will directly impact the formulation of effective and safe pharmaceutical products, ensuring alignment with regulatory guidelines and contributing to the success of clinical trials. This is an excellent opportunity to combine hands-on laboratory work with mentorship and strategic planning in a collaborative, cross-functional environment.What You’ll Do:
- Develop and apply advanced PBPK modeling techniques to predict drug dissolution, absorption, and bioavailability.
- Design and optimize dissolution experiments, ensuring the use of appropriate testing conditions to simulate in vivo scenarios.
- Utilize software tools such as GastroPlus to model gastrointestinal conditions and guide formulation development.
- Collaborate with cross-functional teams, including clinical pharmacologists, medicinal chemists, and formulation scientists, to integrate biopharmaceutics principles into drug development strategies.
- Analyze human and animal clinical data to predict outcomes in subsequent human trials and support formulation adjustments.
- Provide mentorship and training to a small team of Scientists, fostering knowledge sharing and technical development.
- Contribute to regulatory submissions by providing biopharmaceutics expertise, including IVIVC (In Vitro-In Vivo Correlation) and MIDD (Model-Informed Drug Development).
- Stay current with advancements in predictive modeling, dissolution testing methodologies, and regulatory requirements.
- Prepare and deliver technical reports, presentations, and publications to communicate findings to stakeholders.
- Act as a scientific leader in oral formulation, driving innovation and collaboration across teams.
You are a detail-oriented scientist with a passion for advancing pharmaceutical development through biopharmaceutics and predictive modeling. You thrive in dynamic environments, balancing hands-on laboratory work with strategic leadership and mentorship. You have a natural curiosity for solving complex challenges and excel at integrating data-driven insights into actionable strategies. Your collaborative mindset and ability to work across disciplines make you a trusted partner within cross-functional teams.Required
- A PhD in Pharmacokinetics, Pharmaceutical Science, Computational Modeling, or a related field and 6 years of experience in oral dosage form development. A Master’s degree in with at least 8 years of experience in oral dosage form development. Or a Bachelor’s degree with at least 10 years of experience in oral dosage form development.
- Experience supporting regulatory submissions with biopharmaceutics expertise.
- Expertise in PBPK modeling and pharmacokinetics, with proficiency in software tools such as GastroPlus, Phoenix WinNonlin, and Simcyp.
- Strong knowledge of dissolution testing methodologies and ability to design experiments with accurate testing conditions.
- Experience in applying biopharmaceutics principles to late-stage drug development and formulation optimization.
- Familiarity with FDA, EMA, and ICH guidelines related to biopharmaceutics and predictive modeling.
- Excellent analytical, problem-solving, and communication skills.
- Exposure to machine learning applications in pharmaceutical modeling.
- A strong publication record in biopharmaceutics, dissolution, or computational drug development.
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation