Sr. Formulation Scientist

Senior Formulation Scientist

Role Summary

Senior Scientist Formulation & Development (Biologicals / Peptides)

Key Responsibilities

Peptide & Biological Injectable Formulation (Core)

• Lead formulation development for synthetic peptides and biological injectables, integral drug–device combinations, including sterile solutions and lyophilized formats where applicable.
• Execute peptide/biologic pre-formulation: structural and chemical stability profiling, aggregation tendency, oxidation/deamidation mapping, and excipient compatibility.
• Design formulations to protect biological activity and shelf-life under real-world storage and transport conditions (including cold-chain needs).
• Define CQAs/CPPs and apply QbD/DoE to ensure robustness and scalability.

Biologically Derived Carrier / Payload-Delivery Systems

• Develop formulations for biologically derived delivery platforms intended to transport genetic/molecular payloads.
• Ensure viability, stability, delivery efficiency, and manufacturability of the carrier and payload components.
• Build and validate handling, storage and in-use protocols suited to clinical translation.

Analytical & Stability Strategy

• Partner with Analytical/Biological teams to finalize methods, controls, specifications, and impurity/variant tracking.
• Design and interpret stability studies (accelerated/long-term/in-use/stress), including degradation pathway control.

Scale-Up & Tech Transfer for Biological Products

• Lead scale-up readiness and transfer to manufacturing/CDMOs with biologic-appropriate sterilization, filtration, filling, and packaging strategies.
• Support validation approaches and ongoing process capability improvements.
• Author/review biologics/peptide formulation and stability sections in global dossiers.
• Provide defensible scientific rationale for excipient choice, process controls, and stability models to regulators.

Qualifications

• Ph.D./M.Pharm/MS in Pharmaceutics/Biotechnology/Protein or Peptide Sciences/Pharmaceutical Sciences (or related).
• 6-8+ years in peptide/biologic formulation and sterile injectable development.
• Demonstrated expertise in biological stability risk management (aggregation, oxidation, deamidation, adsorption, potency loss).
• Strong QbD/DoE mindset and experience with sterile biologic product development.
• Knowledge of ICH and biologics-specific regulatory expectations.

Preferred

• Experience with biologically derived delivery carriers and payload-stabilization constraints.