Principal Scientist, Long-Acting Injectable Sterile Product Development

Merck & Co.

Rahway (NJ)

On-site

USD 173,000 - 273,000

Full time

6 days ago

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Benefits offered by this job

Annual bonus

Long-term incentive

Benefits package

Job summary

Merck & Co. in Rahway, NJ is seeking a principal LAI formulation scientist to lead the design, development, and lifecycle management of long-acting injectable products across depot, microspheres, and in situ forming systems.

You will guide cross-functional teams, define CQAs and CPPs, optimize release mechanisms, and ensure scalable manufacturing, regulatory readiness, and patient-centric delivery throughout development and tech transfer.

Qualifications

Deep expertise in parenteral drug product development and LAI formulations.
Experience applying QbD and DOE to formulation and process development.
Experience with scale-up, validation, and technology transfer for sterile products.

Responsibilities

Lead design, development, and lifecycle management of LAI products.
Provide strategic leadership on cross-functional programs and CQAs/CPPs.
Drive regulatory readiness and support CMC submissions.

Skills

Parenteral development

LAI delivery systems

QbD & DOE

Cross-functional leadership

Drug-polymer interactions

Scale-up & tech transfer

Regulatory submissions

Mentoring

Education

Ph.D. in Pharmaceutics/Pharmaceutical Sciences/related field

M.S. in Pharmaceutics/Pharmaceutical Sciences/related field

B.S. in Pharmaceutics/Pharmaceutical Sciences/related field

Job description

Job Description

The Sterile Product Development group is responsible for the development of parenteral dosage forms, including long-acting injectables (LAIs), across small molecules, peptides, and biologics from preclinical development through commercialization. Our teams enable robust and scalable drug product and delivery solutions through deep scientific understanding of formulation, drug-excipient interactions, delivery system performance, and manufacturing processes, ensuring product quality, safety, efficacy, and patient-centric design.

Primary Duties

Serve as a principal-level LAI formulation scientist, providing scientific leadership for the design, development, and lifecycle management of long-acting injectable drug products, including depot, sustained-release, and controlled-delivery parenteral dosage forms
Lead LAI formulation and delivery strategy development, including selection and optimization of release mechanisms (e.g., polymer-based depots, suspensions, microspheres, in situ forming systems), excipient systems, and delivery approaches to meet target product profiles
Provide strategic technical leadership on cross-functional program teams, ensuring alignment of formulation, drug substance properties, delivery system performance,
container/closure systems, manufacturability, and clinical use considerations throughout development
Design and interpret studies to understand and control release kinetics, stability, and performance, including:
Drug-excipient and drug-polymer interactions
In vitro and in vivo performance relationships
Physical stability, aggregation, and particle size control
Syringeability, injectability, and device compatibility
Support early- and late-stage development programs, including:
Selection of scalable manufacturing processes for LAIs
Definition of formulation and process design space
Support for clinical and commercial process scale-up and validation
Technology transfer to GMP manufacturing facilities
Partner closely with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering teams to:
Define critical quality attributes (CQAs) and critical process parameters (CPPs) relevant to LAI performance
Support clinical strategy through formulation design and risk mitigation
Contribute to CMC regulatory submissions and health authority interactions
Provide scientific oversight and mentoring to junior scientists, fostering capability development in LAI formulation science, experimental design, and data-driven decision making
Maintain awareness of emerging LAI technologies and delivery platforms, contributing to internal capability assessments, external collaborations, and innovation initiatives aligned with portfolio and organizational strategy

Minimum Education Requirements

Ph.D. with 7+ years industry experience, or
M.S. with 10+ years, or
B.S. with 14+ years in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline

Required Experience and Skills

Deep expertise in parenteral drug product development, with demonstrated experience in long-acting injectable or sustained-release formulations
Strong scientific understanding of:
Controlled-release mechanisms and LAI delivery systems
Drug-polymer and drug-excipient interactions
Formulation stability and performance characterization
Experience applying Quality by Design (QbD) principles and DOE approaches to formulation and process development
Experience supporting process scale-up, validation, and technology transfer for sterile injectable products
Working knowledge of CMC regulatory expectations for parenteral and extended-release products, including development-stage and commercial submissions
Demonstrated ability to lead cross-functional teams, influence strategy, and communicate complex scientific concepts clearly
Proven mentoring and scientific leadership skills at the senior/principal level

Preferred Experience and Skills

Experience with LAI-specific platforms, such as polymer depots, microspheres, nanosuspensions, or in situ forming systems
Experience with device-drug product integration, including prefilled syringes or delivery systems relevant to LAIs
Understanding of clinical and patient-centric considerations influencing LAI design (e.g., dosing interval, injection volume, administration route)
Experience supporting global regulatory filings and health authority interactions
Track record of contributing to publications, patents, or external scientific collaborations in drug delivery or formulation science

Required Skills:

Adaptability, Adaptability, Cell Culture Process Development, Cell Line Development, Combination Products, Data Analysis, Drug Delivery, Drug Development, Drug Formulations, Finite Element Analysis (FEA), Functional Management, Innovative Thinking, Leadership Mentoring, Pharmaceutical Process Development, Pharmaceutical Products, Pharmaceutical Research, Pharmaceutical Sciences, Pharmaceutics, Process Development (PD), Process Scale Up, Product Development, Product Development Lifecycle, Product Formulation, Professional Collaboration, Professional Networking {+ 8 more}

Preferred Skills:

US and Puerto Rico Residents Only:

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The primary location for this posting is:

USA - New Jersey - Rahway

Where required by law, the compensation range for this role is provided below.

The salary range for the primary location of this role is:

$173,200.00 - $272,600.00

This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 .

Additional location(s):

Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location.

Additional location(s) Compensation Information:

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

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated