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
