About the role
Location: Vapi, Gujarat
Job Type: Full-time, Permanent
Experience: 5–10 years
Education: M.Sc. / M.Tech. in Chemistry, Pharmaceutical Chemistry or a related field
Department: R&D / Process Development
About the Role
A pharmaceutical manufacturer is looking for an experienced R&D professional to lead the development of ferric and ferrous iron complexes. You will take products from laboratory development through process optimization, pilot trials, scale-up and technology transfer, working independently and closely with cross-functional teams.
Key Responsibilities
- Develop and optimize ferric and ferrous iron complexes and related iron-based products.
- Develop processes for iron sucrose, iron polymaltose / iron hydroxide polymaltose complex, ferric carboxymaltose, iron isomaltoside and other iron-carbohydrate or iron-polymer complexes.
- Plan and execute laboratory and pilot-scale experiments for new product development.
- Work on reaction chemistry, complex formation, precipitation, oxidation/reduction, and control of pH, temperature, reaction time, concentration and addition sequence.
- Manage isolation and purification steps, including filtration, washing, cake dissolution, re-precipitation and drying optimization.
- Optimize critical quality attributes such as molecular weight, PDI, particle size, zeta potential, iron content, oxidation state (Fe²⁺/Fe³⁺), solubility, stability and purity.
- Interpret analytical data (GPC, Zetasizer, FTIR, UV, iron assay, chloride, moisture, elemental analysis) and correlate process parameters with product quality.
- Troubleshoot precipitation, aggregation, colour changes, molecular-weight variation, yield issues and batch-to-batch inconsistency.
- Evaluate raw materials and their impact on process performance and final product quality.
- Prepare and maintain batch records, experimental protocols, development reports, SOPs, scale-up protocols and technology transfer documents.
- Coordinate with Analytical, QC, QA, Production and Engineering teams during development, pilot, validation and scale-up batches.
- Identify opportunities for process improvement, yield improvement and cost reduction.
Required Skills
- Strong practical knowledge of iron chemistry and coordination / complex chemistry.
- Hands-on experience in ferric and/or ferrous iron complex development.
- Good understanding of iron oxidation and reduction chemistry.
- Experience in iron-carbohydrate and iron-polymer complexes.
- Proven experience in process optimization and lab-to-pilot scale-up.
- Working knowledge of GPC and Zetasizer data interpretation (Mw, Mn, PDI, Z-average, zeta potential).
- Ability to identify relationships between critical process parameters and critical quality attributes.
- Strong troubleshooting, problem-solving and technical report-writing skills.
Preferred Experience
- Pharmaceutical / API development of parenteral or injectable iron products.
- Exposure to iron dextran, iron polysaccharide complexes or ferric maltol.
- Familiarity with GMP documentation, risk assessment and process validation support.
Ideal Candidate
A technically strong R&D professional who can independently take an iron-complex product from lab development, through process optimization and pilot trial, to scale-up and technology transfer.
Benefits
- Opportunity to work on high-value pharmaceutical iron products
- Exposure to lab, pilot-scale and technology transfer activities
- Growth-oriented R&D environment