About the role
About the Role
A pharmaceutical R&D organization specializing in injectable and API products is seeking an experienced Process Development Scientist to join its Iron Complex Development team. This role is ideal for a candidate with strong, hands-on experience in iron chemistry who wants to lead process development from lab scale through technology transfer.
Key Responsibilities
- Develop and optimize ferric and ferrous iron complexes and related iron-based products
- Design and execute laboratory and pilot-scale experiments for new product development
- Work on reaction chemistry, complex formation, precipitation, oxidation/reduction, pH, temperature, reaction time, and other process parameters
- Develop processes for iron sucrose, iron polymaltose/iron hydroxide polymaltose complexes, ferric carboxymaltose, iron isomaltoside, and related iron-carbohydrate or iron-polymer complexes
- Optimize critical quality attributes including molecular weight, particle size, PDI, iron content, oxidation state, solubility, stability, and purity
- Troubleshoot precipitation, aggregation, color changes, molecular-weight variation, yield, and batch-to-batch consistency issues
- Develop and document process parameters, batch procedures, development reports, and scale-up protocols
- Coordinate with Analytical, QC, QA, Production, and Engineering teams during development and scale-up
- Support pilot trials, process scale-up, technology transfer, and validation batches
- Evaluate raw materials and assess their impact on process performance and product quality
- Interpret analytical data such as GPC, particle size, zeta potential, iron assay, and elemental analysis
- Maintain laboratory records and prepare technical development reports
Required Qualifications
- M.Sc. or M.Tech. in Chemistry, Pharmaceutical Chemistry, or a related field
- 5–7 years of hands-on experience specifically in iron compound / iron complex development (required)
- Strong practical knowledge of iron chemistry and coordination/complex chemistry
- Working knowledge of iron oxidation-reduction chemistry
- Experience controlling pH, temperature, reaction time, concentration, and addition sequence in process development
- Familiarity with iron-carbohydrate and iron-polymer complexes
- Experience in process optimization and scale-up from lab to pilot scale
- Strong analytical, troubleshooting, and technical documentation skills
Preferred Experience
- Background in pharmaceutical/API development of parenteral iron products or injectable iron complexes is highly preferred
What We Offer
- Opportunity to lead end-to-end development, from lab work to technology transfer
- Collaborative, cross-functional R&D environment