Formulation Scientist (Small Molecules / Sterile Injectables)

Lead Scientist – Formulation & Development (Small Molecules / Sterile Injectables) Role Summary Venus Remedies is seeking a Lead Scientist – Formulation & Development (Small Molecules) to lead sterile injectable development for new off-patent small molecules and non-hormone/non-steroid parenteral products. The role spans feasibility through commercial readiness, with strong ownership of complex injectable generics, safety-enhanced reformulations, and IND-enabling formulations for differentiated molecules. A core expectation is deep, hands-on capability in troubleshooting and lifecycle strengthening of high-value sterile products across oncology and non-oncology portfolios. Key Responsibilities Sterile Injectable Development (Core) Lead end-to-end formulation development of parenteral dosage forms: solutions, suspensions, lyophilized products, complex/combination injectables. Execute pre-formulation studies: physicochemical characterization, solubility & pH profiling, excipient compatibility, forced degradation, and stability risk mapping. Apply QbD/DoE to define CQAs/CPPs, build robust control strategies, and ensure scalable, reproducible formulations. Select excipients scientifically with clear rationale aligned to global regulatory expectations. Safety-Enhanced Reformulation / Platform Molecules Lead formulation programs aimed at reducing toxicity / improving tolerability of established antimicrobial or critical-care injectable classes via formulation and delivery approaches. Develop IND-ready drug products for novel derivatives/platform molecules, ensuring rapid concept-to-clinic translation. Troubleshooting & Lifecycle Management (Must-Have) Independently troubleshoot sterile products prone to instability or manufacturing challenges. Solve issues such as precipitation, pH drift, degradation, incompatibility, particulate formation, lyophilization defects, container-closure interactions, and cold-chain deviations. Drive product robustness, manufacturability enhancement, cost optimization, and post-approval changes. Other deliverables Lead pilot/scale-up batches and transfer processes to GMP sites. Review/approve batch records, transfer protocols, PPQ readiness packages, and process risk assessments. Author/review dossier sections covering formulation rationale, process design, controls, stability, and lifecycle change strategies. Provide strong scientific responses to regulatory queries. Mentor scientists/associates; review protocols, raw data, and reports. Manage deliverables, timelines, and budgets.Qualifications Ph.D./M.Pharm/MS in Pharmaceutics/Pharmaceutical Sciences. 10+ years in sterile injectable formulation & development including lyophilized products. Strong record in off-patent small molecules, complex generics, and commercial troubleshooting. Expertise in QbD/DoE, excipient science, stability design, scale-up, process optimization and tech transfer. Knowledge of ICH and global regulatory expectations

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