Associate Principal Scientist, Long-Acting Injectable Sterile Product Development
Merck & Co.
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Benefits offered by this job
Job summary
Merck & Co. is seeking an LAI formulation scientist to lead the design, development, and lifecycle management of long-acting injectable products across depot and sustained-release systems.
You will drive program strategies, optimize release mechanisms, and collaborate with process development, regulatory, and manufacturing teams. The role requires deep expertise in parenteral drug product development, knowledge of CMC regulatory expectations, and a track record of leading cross-functional
Qualifications
- Deep expertise in parenteral drug product development and LAI formulations.
- Experience applying QbD and DOE to formulation and process development.
- Experience leading cross-functional teams and communicating complex science clearly.
Responsibilities
- Serve as an LAI formulation scientist, providing scientific leadership for design, development, and lifecycle management of long-acting injectable products.
- Lead LAI formulation and delivery development for programs, selecting release mechanisms and excipient systems to meet target product profiles.
- Provide technical leadership on cross-functional teams, ensuring alignment of formulation, drug substance, delivery system, and manufacturing considerations.
Skills
Education
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.
- 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
- 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
- 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
- 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
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}
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:
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 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.
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 .
-We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
-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
Regular
Domestic
Yes
10%
Not Applicable
Not Indicated
No
n/a
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