Consultant – Formulation
vor 2 Wochen
International consulting group founded in 2019, Ekkiden fosters an ecosystem of passionate and committed consultants who lead organizational, operational, and technological transformation projects in IT/Digital, Industry/R&D, and Sustainability for large corporations and SMEs in France, Switzerland, Spain, and Germany.
Project Context:
As part of the final stage of development of new subcutaneous injectable products based on dried PLGA microparticles and compatible diluents, we are looking for an expert to reinforce our R&D team.
These products are sustained-release formulations intended for endocrinology applications.
This project is part of an international dynamic:
Analytical development activities outsourced to the Netherlands
Process development laboratory located in Switzerland, with collaborating teams in Berlin
Integration planned for January 2026 with an expanded team in Copenhagen
The objective is to consolidate technical resources to finalize formulation development and prepare the next industrial and regulatory milestones.
Responsabilities:
As a Formulation / Development Consultant, you will join the technical team to:
Contribute to the late-stage development of PLGA-based drug products (dried microparticles, microsphere-based powders, reconstitution/diluent systems for SC injection).
Support optimization and finalization of formulation parameters and manufacturing processes for sustained-release PLGA microparticles.
Collaborate closely with the current development lead (15+ years of experience) on formulation robustness, scale-up considerations, and product characterization (particle size, morphology, encapsulation efficiency, in vitro release, rheology, reconstitution properties, etc.).
Participate in inter-site knowledge transfer as the project transitions to larger teams.
Provide scientific and technical support to external partners (contract labs, analytical consultants, device & packaging specialists).
Contribute to drafting and reviewing technical and regulatory documentation, including protocols, reports, specifications, and risk assessments.
(Plus) Contribute to preclinical readiness activities; experience performing or supporting in vivo rat studies is strongly valued.
What we're looking for:
Advanced degree in chemistry, pharmaceutics, galenics, chemical engineering, or biotechnology (Master's/PhD).
6–10 years of experience developing microparticle or microsphere formulations based on PLGA or related biodegradable polymers.
Strong expertise in pharmaceutical formulation, process development, and characterization of sustained-release injectable products.
Experience working on subcutaneous administration products, ideally involving dried or reconstitutable microparticle systems.
Knowledge of GMP norms and expectations for late-stage CMC development; prior exposure to preparing for scale-up or validation is a plus.
Experience with in vivo testing, preferably rodent (rat) models, is a significant asset.
Good understanding of analytical techniques and primary packaging requirements (vials, syringes, dual-chamber systems, etc.).
Experience in a pharmaceutical or biotechnology environment.
Fluent in English; French or German is a plus.
Occasional travel possible to Copenhagen or Berlin.
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