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Research and Development Manager (API)
About this role
Emzor Pharmaceutical Industries Limited in Ogun is seeking an experienced API Research and Development Manager. The role leads API technology transfer and process validation, strengthens technical and GMP documentation, and supports process optimisation and the development of new API opportunities, coordinating cross-functional activities required for API manufacturing and development. It is suited to professionals with extensive API R&D and pharmaceutical manufacturing experience.
What you would do
- Lead API manufacturing and analytical method technology transfer for identified legacy APIs.
- Plan, coordinate and document API process validation batches, including protocols, batch records, process data, investigations, and validation reports.
- Review development protocols, processes, reports and technical documents to ensure accuracy, completeness, and GMP compliance.
- Identify technical gaps, process risks, and opportunities for process optimisation, troubleshooting, and scale-up.
- Review and strengthen Product Development Reports, SOPs, master records, batch records, process-characterisation reports, validation reports, and investigation reports.
- Provide timely technical documentation support to Regulatory Affairs for product registration and supplement filings.
What they are asking for
- Bachelor's degree or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or related scientific discipline.
- Relevant postgraduate qualification or professional certification in pharmaceutical manufacturing, process development, or related field is advantageous.
- Extensive experience in API research and development, pharmaceutical manufacturing, technology transfer, process validation, or related area.
- Strong knowledge of GMP, Quality by Design (QbD), risk-based development, process optimisation, and technical documentation.
- Experience managing cross-functional technical projects and working with external technical partners.
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