Job highlights

- Prepare and maintain batch records,experimental protocols,development reports,SOPs,scale-up protocols and technology transfer documents.
- Required Skills
- Preferred Experience
- Experience in iron-carbohydrate and iron-polymer complexes.
- Proven experience in process optimization and lab-to-pilot scale-up.

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 (Fe /Fe ), 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.
- Positive 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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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