Chemical Industry
Formulation Scientist
Overijssel, NetherlandsOn-siteFreelanceStart date 11/2025
ChemistryBiopharmaceuticalsBusiness RequirementsChemical EngineeringClinical WorksClinical ResearchRegulatory ComplianceManufacturingMultidisciplinary ApproachParticle Size AnalysisPharmaceuticalsPharmacologyPolymer ChemistryProcess DevelopmentStakeholder ManagementEncapsulation (Networking)MorphologyQuality By Design (QbD)Risk AssessmentManufacturing Processes
Description
We are seeking a Senior Formulation Scientist with proven expertise in the development of microsphere?based injectable drug products. You will initially join on a contract?to?permanent basis, playing a pivotal role in advancing a novel controlled?release formulation from early development through clinical?enabling studies and IND/IMPD submission into clinical trials. For the right candidate, this assignment offers a clear pathway to a permanent position with full employee benefits.
This assignment is ideal for a scientist who has already delivered bench?to?clinic success with microsphere technologies (e.g., PLGA, polylactide, or other biodegradable polymers) in a biopharmaceutical setting.
Key Responsibilities
Requirements
What We Offer
This assignment is ideal for a scientist who has already delivered bench?to?clinic success with microsphere technologies (e.g., PLGA, polylactide, or other biodegradable polymers) in a biopharmaceutical setting.
Key Responsibilities
- Lead the design, development, and optimization of microsphere?based formulations for parenteral delivery.
- Establish and validate manufacturing processes (e.g., solvent evaporation, spray drying, microfluidics) suitable for scale?up and clinical supply.
- Conduct stability studies, release kinetics, and characterization of microsphere formulations.
- Generate CMC documentation to support IND/IMPD submissions and regulatory interactions.
- Collaborate with analytical, process development, and regulatory teams to ensure clinical readiness.
- Provide SME input on controlled?release technologies, risk assessment, and mitigation strategies.
- Support tech transfer to CDMOs for GMP manufacturing of microsphere formulations.
- Mentor junior scientists and contribute to knowledge sharing within the R&D team.
Requirements
- PhD in Pharmaceutics, Chemistry, Chemical Engineering, or related discipline.
- 7-10 years of industrial experience in biopharmaceutical formulation development.
- Experience advancing microsphere?based injectables from early development through IND/IMPD submission into clinical trials.
- Hands?on expertise with microsphere technologies (PLGA, polylactide, or other biodegradable polymers).
- Strong background in analytical characterization (particle size, morphology, encapsulation efficiency, in vitro release).
- Familiarity with QbD principles, regulatory CMC requirements, and IND/IMPD documentation.
- Experience with scale?up and tech transfer to GMP manufacturing.
- Excellent communication skills in English; able to present complex data to internal and external stakeholders.
What We Offer
- A contract?to?permanent opportunity: start as a contractor with the option to transition into a permanent role based on performance and business needs.
- As a permanent employee, you would be eligible for a comprehensive benefits package, including:
- Pension scheme
- Annual performance bonus
- 30 days of annual leave (based on full?time employment)
- Additional benefits aligned with company policy (e.g., health coverage, training budget, flexible working).
- The chance to shape early?phase development of a novel microsphere?based injectable with direct impact on clinical pipeline progression.
- Collaboration with a multidisciplinary, international team of scientists, clinicians, and regulatory experts.