Associate Principal Scientist, Long-Acting Injectable Sterile Product Development

MSD Malaysia; Rahway (NJ); On-site; USD 142,000 - 224,000; Full time

Job summary

Merck & Co., Inc. in Rahway, NJ, seeks an Associate Principal Scientist to lead long-acting injectable (LAI) formulation strategies across multiple programs.

You will guide design, development, and lifecycle management of depot, sustained-release, and delivery systems, coordinating with GMP manufacturing and regulatory teams. Ideal candidates bring deep LAI expertise, cross-functional leadership, and strong experience with QbD and process validation to ensure scalable, high-quality parenteral

Qualifications

• Deep expertise in parenteral drug product development, with demonstrated experience in long-acting injectable or sustained-releasing formulations.
• Strong scientific understanding of controlled-release mechanisms and LAI delivery systems, drug-polymer and drug-excipient interactions.
• 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.

Responsibilities

• Serve as an LAI formulation scientist, providing scientific leadership for design, development, and lifecycle management of long-acting injectable drug products.
• Lead LAI formulation and delivery development for one or more programs, including selection and optimization of release mechanisms and excipient systems.
• Provide technical leadership on cross-functional program teams, ensuring alignment of formulation, drug substance properties, delivery system performance, and manufacturing considerations.

Skills

LAI Formulation

Parenteral Delivery

QbD / DOE

Scale-Up

Cross-Functional

Education

Ph.D. with 4+ years

Job description

Job Description Overview: 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 an Associate 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 an 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 development for one or more programs, 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 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 on project teams, 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
• Enhance our Company's professional image and competitive advantage through generation of patents, external presentations, publications, and professional organizations related to sterile product development and/or long-acting injectables

Minimum Education Requirements

Ph.D. with 4+ years industry experience, or M.S. with 8+ years, or B.S. with 10+ 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-releasing 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

Preferred Experience and Skills

• Experience with several 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

• Bioprocess Engineering
• Bioprocess Engineering
• Cell Line Development
• Chemical Engineering
• Downstream Process Development
• Drug Delivery
• Drug Delivery Technology
• Drug Development
• Drug Formulations
• Early Phase Clinical Trials
• Expression Vectors
• Kinetics
• Molecular Biology
• Pharmaceutical Formulations
• Pharmaceutical Process Development
• Pharmaceutical Products
• Pharmaceutical Research
• Pharmaceutical Sciences
• Pharmaceutical Technologies
• Pharmaceutics
• Physical Characterization
• Product Development Lifecycle
• Product Formulation
• Regulatory Submissions
• Stable Cell Lines
• {+ 1 more}

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: EEOC Know Your Rights EEOC GINA Supplement

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 line?? The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

The salary range for this role is $142,400.00 - $224,100.00. 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.

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

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.