Senior Scientist, Sterile Product Development (Onsite)

Merck; New Jersey; Sur place; USD 120 000 - 180 000; Plein temps

Résumé du poste

Merck is seeking a Senior Scientist to advance sterile product development for long-acting injectables and peptide drug conjugates. The role involves hands-on formulation design, data interpretation, and leadership within cross-functional teams to guide development from early research through planning for commercialization.

The successful candidate will independently execute studies, assess stability and performance, apply Quality by Design principles, and contribute to regulatory discussions

Qualifications

• Strong foundation in parenteral formulation or process development.
• Experience with long-acting injectables and peptide drug conjugates.
• Knowledge of DOE and Quality by Design in formulation development.

Responsabilités

• Design, execute, and interpret formulation studies for LAI and PDCs.
• Evaluate approaches including polymer-based systems and crystalline suspensions.
• Collaborate with cross-functional teams on formulation and process development.
• Support technology transfer to GMP manufacturing facilities and clinical/regulatory interactions.
• Provide scientific leadership for defined workstreams and communicate results.

Connaissances

Parenteral formulation

Long-acting injectables

Peptide drug conjugates

DOE / QBD

Formation

Ph.D. with 0 years industry experience

M.S. with 4+ years industry experience

Description du poste

Role Overview:

The Sterile Product Development group develops parenteral dosage forms, including long-acting injectables and peptide drug conjugates across small molecules, peptides, and biologics from preclinical development through commercialization. Our teams develop robust, scalable drug product and delivery solutions through scientific understanding of formulation, drug-excipient interactions, delivery system performance, and manufacturing processes, with a focus on product quality, safety, efficacy, and patient-centric design.

The Senior Scientist is a hands‑on individual contributor supporting the scientific development of long-acting injectables, peptide drug conjugates, and other parenteral formulations. The successful candidate will independently design and execute studies, interpret data, and provide formulation and process development recommendations within multidisciplinary teams. The role includes technical input and scientific leadership of defined experimental or development workstreams, in alignment with project objectives and guidance from project leads.

Responsibilities:

Design, execute, and interpret formulation and process development studies for long-acting injectables and peptide drug conjugates, as well as conventional parenteral formulations. Evaluate approaches appropriate to each molecule and product, including polymer-based controlled-release systems and crystalline suspensions for long-acting injectables.

Provide scientific input to cross-functional teams on formulation, drug substance properties, delivery system performance, container/closure compatibility, manufacturability, and clinical in-use considerations. Take technical responsibility for assigned workstreams, communicate findings and risks, and recommend next steps to project leads.

Design, conduct, and interpret studies to understand formulation stability and product performance for long-acting injectables and peptide drug conjugates, including release kinetics where relevant:

• Drug-excipient and drug-polymer interactions
• In vitro and in vivo performance relationships

• Physical stability, solubility, aggregation, and particle size control, as appropriate to the formulation
• Syringe ability, injectability, and device compatibility

• Chemical stability of drug substances and formulated products, including peptide and conjugate integrity and formation of free drug in peptide drug conjugates
• Support early‑and late‑stage development programs, including:
• Experimental evaluation and recommendation of scalable manufacturing processes for long-acting injectables and peptide drug conjugates
• Characterization of formulation and process variables to support definition of design space
• Support for clinical and commercial process scale‑up and validation
• Technology transfer to GMP manufacturing facilities

Collaborate with Clinical, Non-Clinical, Quality, Regulatory, Manufacturing, and Engineering colleagues, contributing experimental data and scientific recommendations to: Identify and characterize critical quality attribute and critical process parameters relevant to LAI and PDC quality, stability, and performance

Support clinical strategy through formulation design and risk mitigation

Contribute to CMC regulatory submissions and health authority interactions

Provide scientific leadership within defined workstreams by developing experimental plans, troubleshooting technical challenges, interpreting results, and sharing recommendations. Offer informal technical guidance and knowledge sharing to colleagues without responsibility for people management or overall project delivery.

Maintain awareness of emerging LAI technologies and PDC formulation and delivery approaches; contribute scientific assessments and experimental support to capability development, external collaborations, and innovation initiatives aligned with team priorities.

Contribute to patents, external presentations, publications, and professional scientific activities related to sterile product development, long-acting injectables, and peptide drug conjugates.

Minimum Education Requirements:

• Ph.D. with 0 years industry experience, or
• M.S. with 4+ years industry experience in Pharmaceutics, Pharmaceutical Sciences, Chemical Engineering, Biochemical Engineering, Chemistry, Materials Science, or a related discipline

Required Experience and Skills:

• Strong scientific foundation and hands‑on or academic experience in parenteral formulation or process development, with relevant experience in long-acting injectables, sustained‑release formulations, peptides, or drug conjugates, and the ability to apply this experience across LAI and PDC development.
• Experience applying Quality by Design principles and DOE approaches to formulation and process development
• Experience contributing experimental or technical support to process scale‑up, validation, or technology transfer for sterile injectable products
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• Demonstrated ability to independently plan and ex