Sr. Scientist, Preclinical Dev.

Job Description

Job Description

The Biologics & Biopharmaceutics team is an integrated team responsible for the development and successful registration of new drug products. Formulation activities focus on the development of non-oral dosage forms spanning preclinical toxicology studies through commercialization. We ensure robust composition, primary packaging/device, and process selection through deep fundamental understanding and characterization such that the process is scalable without compromising stability, safety, efficacy, and delivery. Biopharmaceutics scientists proactively develop and execute a comprehensive biopharmaceutics strategy that leverages cutting edge in vitro, in vivo and in silico Physiologically Based Pharmacokinetics (PBPK) and PK modeling tools, while advancing the underlying biopharmaceutics science within the organization and the external scientific community.

Our team is looking for a strong candidate for the position of Senior Scientist to support biopharmaceutics assessment across delivery of small molecule, peptides and biologic modalities. The successful candidate will be responsible for representing the biopharmaceutics team in drug product development teams, driving the biopharmaceutics strategy, while helping to develop the next generation of physiologically-based modeling and simulation tools.

Primary Responsibilities

• Proactively identify key biopharmaceutics risks at each stage of drug product development for biologics, peptides, and small molecules through rigorous, integrated hypothesis‑driven assessments, driving the development of in vitro–in vivo relationships (IVIVR) and strengthening preclinical‑to‑clinical translation of formulation bioperformance.

• Influence formulation and delivery strategies for parenterally administered biologic modalities and protein therapeutics by considering absorption kinetics, stability and immunogenicity

• Develop and apply quantitative absorption models to support formulation decisions, bioperformance risk assessment, IVIVR development, and clinically relevant specification setting across oral and parenteral drug products.

• Actively contribute to internal and external innovation in biopharmaceutics and quantitative modeling through scientific collaboration and capability development.

• Contribute to biopharmaceutics strategies development across administration routes, including oral dissolution and absorption, as well as subcutaneous delivery considerations, such as lymphatic uptake, interstitial transport, enzyme-mediated degradation, and formulation effects on absorption.

• Collaborate closely with formulation scientists, analytical teams, clinical pharmacology, and device/delivery experts to advance biologic programs and de-risk bridging strategies.

• Communicate scientific findings and recommendations clearly to cross-functional teams, governance forums, and external scientific audiences.

Desired Qualifications

• PhD in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, or a related field with 0–3 years of experience.

• Master’s degree in Pharmaceutics, Pharmacokinetics, Pharmaceutical Sciences, or a related field with at least 5 years of industry experience.

Required Experience and Skills

• Strong foundation in pharmacokinetics and PK modeling principles.

• Working knowledge of formulation and biopharmaceutics principles relevant to small molecules, peptides, and/or biologics.

• Effective communication with the ability to present scientific data clearly, support decision-making, and solve complex problems.

• Demonstrated ability to work effectively with interdisciplinary and matrix team environments.

• Self-motivated with strong ownership, accountability, and follow-through.

• Scientific contributions through publications and conference presentations in biopharmaceutics, PK, biologics or related fields.

Preferred Experience and Skills

• Hands-on experience with absorption modeling tools such as Simcyp, GastroPlus, Phoenix, PK-Sim, or related platforms.

• Direct experience modeling or characterizing subcutaneous absorption of biologics, including monoclonal antibodies, fusion proteins, peptides, or related modalities.

• Experience with computational and data analysis tools such as MATLAB, Python, R, Phoenix, or similar software.

• Familiarity with formulation, device, and delivery considerations for subcutaneous administration, including injectability, stability, and compatibility.

• Experience designing, executing, or interpreting in vivo PK studies and applying findings to translational assessments.

• Familiarity with specialized dosage forms or advanced delivery systems, including extended release, inhaled, or other non-oral platforms.

Required Skills:

Adaptability, Biopharmaceutics, Communication, Data Analysis, Dosage Forms, Innovative Thinking, PBPK Modeling, Pharmacokinetics

Preferred Skills:

Biopharmaceuticals, Dissolution Testing, Drug Delivery, Drug Product Development, Formulation Development, Regulatory Submissions

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics.  As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities.  For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:

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We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

The salary range for this role is

$117,000.00 - $184,200.00

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

05/15/2026

*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.