Senior Scientist, Sterile Product Development (Onsite)

Job description

Job Description 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 undefined Demonstrated ability to independently plan and execute studies, interpret complex data, and communicate clear scientific recommendations; collaborate effectively across functions and provide technical leadership within a defined workstream without formal supervisory or project leadership authority Preferred Experience and Skills: Experience with LAI platforms such as polymer depots, microspheres, nanosuspensions, or in situ forming systems; experience spanning both LAI and peptide or drug-conjugate development is particularly valuable Working knowledge of CMC regulatory expectations for sterile parenteral products and the scientific documentation needed to support development-stage and commercial submissions Scientific understanding of the following principles and their application to LAI and PDC development:Controlled-release mechanisms, LAI delivery systems, and relationships between formulation attributes and product performance Drug–polymer and drug–excipient interactions Hands-on experience developing peptide or peptide drug-conjugate formulations, including characterization of stability, conjugate integrity, aggregation, free-drug formation, and compatibility with formulation and manufacturing conditions Experience with device–drug product integration, including prefilled syringes or delivery systems relevant to long-acting injectables Understanding of clinical and patient‑centric considerations influencing LAI design (e.g., dosing interval, injection volume, administration route) Physical and chemical stability and characterization of parenteral formulations, including peptide/conjugate integrity, aggregation, and free-drug formation where relevant 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 #PRD #eligibleforERP Required Skills: Chemistry, Data Analysis, Drug Delivery Technology, Drug Product Development, Experience Design, Flow Cytometry, High-Throughput Screening, Interpersonal Relationships, In Vitro Research, Molecular Biology Techniques, Multi-Color Flow Cytometry, Pharmaceutical Sciences, Preformulation, Process Development (PD), Process Optimization 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. 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 requi