Principal Scientist, Oral Formulation (Biopharmaceutics and Predictive Dissolution)

Biogen; Cambridge (MA); On-site; USD 156,000 - 215,000; Full time

Job summary

A leading biotechnology company seeks a Principal Scientist specializing in Oral Formulation to drive drug development through innovative modeling and experimental design. This role requires a PhD and extensive experience in the field, with responsibilities including mentoring staff and contributing to regulatory submissions. Join a collaborative team dedicated to delivering life-changing medications.

Benefits

Medical, Dental, Vision, & Life insurances

Fitness & Wellness programs

Short- and Long-Term Disability insurance

15 days paid vacation plus additional time off

Paid Maternity and Parental Leave

401(k) with company matching

Tuition reimbursement up to $10,000

Qualifications

• PhD required in relevant fields or extensive experience equivalent.
• Experience in drug reformulation and regulatory submissions.
• Expertise in PBPK modeling and dissolution testing methodologies.

Responsibilities

• Lead the development of predictive dissolution and pharmacokinetics modeling.
• Design and oversee dissolution experiments.
• Collaborate with teams on biopharmaceutics strategy integration.

Skills

Pharmacokinetics

Predictive Modeling

Biopharmaceutics

Analytical Skills

Problem-Solving

Education

PhD in Pharmacokinetics or related field

Master’s degree with 8+ years experience in oral dosage development

Bachelor’s degree with 10+ years experience in oral dosage development

Tools

GastroPlus

Phoenix WinNonlin

Simcyp

Job description

Principal Scientist, Oral Formulation (Biopharmaceutics and Predictive Dissolution) page is loaded

Principal Scientist, Oral Formulation (Biopharmaceutics and Predictive Dissolution)

Apply remote type On Campus locations Cambridge, MA time type Full time posted on Posted 6 Days Ago job requisition id REQ20985

About This Role:
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.

Who You Are:
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.

Preferred Skills:

• Exposure to machine learning applications in pharmaceutical modeling.
• A strong publication record in biopharmaceutics, dissolution, or computational drug development.

Job Level: Management

Additional Information

The base compensation range for this role is: $156,000.00-$215,000.00

Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees’ and their families physical, financial, emotional, and social well-being; including, but not limited to:

• 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

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read on to learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

#TeamBiogen

We’re united by a shared purpose, proud of our work, and inspired by one another and the lives we strive to change.

Perks of Biogen

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission.

Caring Deeply. Achieving Excellence. Changing Lives.