Principal Scientist, Long-Acting Injectable Sterile Product Development

Merck

Rahway (NJ)

On-site

USD 173,000 - 273,000

Full time

2 days ago

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Job summary

Merck in Rahway, NJ, is seeking a Principal Scientist to lead long-acting injectable (LAI) formulation development across depot, sustained-release, and injectable delivery systems. You will guide multidisciplinary teams, shape formulation strategy, and ensure robust manufacturing readiness from early development through clinical and commercial stages.

The role emphasizes technical leadership, CQAs, CPPs, and collaboration with Clinical, Regulatory, and Quality groups to accelerate programs while

Qualifications

Deep expertise in parenteral drug product development.
Strong understanding of LAI delivery systems and release mechanisms.
Experience applying QbD and DOE to formulation and process development.
Leadership of cross-functional teams and communication of complex science.

Responsibilities

Provide scientific leadership for design, development, and lifecycle management of LAI drug products.
Lead formulation and delivery strategy development including depots, microspheres, and injectable systems.
Collaborate with Clinical, Quality, Regulatory, Manufacturing, and Engineering teams to define CQAs and CPPs.
Design studies to understand release kinetics, stability, and performance in vitro and in vivo.
Support scale-up, technology transfer to GMP facilities, and regulatory submissions.

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.

This role is a Principal Scientist–level technical leadership position with a primary focus on long-acting injectable drug products, including depot formulations, extended-release systems, and injectable sustained-delivery technologies. The successful candidate will serve as a scientific leader across multidisciplinary teams, shaping LAI formulation and development strategy across the portfolio.

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

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.

Requirements

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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Primary location for this posting is:

USA - New Jersey - Rahway

Salary range for the primary location of this role is:

$173,200.00 - $272,600.00

Benefits

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.

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