Research and Development Manager (API)

Job title : Research and Development Manager (API)

We are seeking an experienced API Research & Development Manager to provide technical leadership for API technology transfer, process validation, process development, technical documentation, and the development of a sustainable pipeline for additional APIs.

ROLE SUMMARY

The API Research & Development Manager will lead API technology transfer and process validation activities, strengthen technical and GMP documentation, support process optimisation and troubleshooting, and coordinate cross-functional activities required for successful API manufacturing and development. The role will also support the identification, prioritisation, and development of new API opportunities.

KEY RESPONSIBILITIES

• Lead the completion of API manufacturing and analytical method technology transfer activities 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 and support to Regulatory Affairs for product registration and supplement filings.
• Apply Quality by Design (QbD) and risk-based development principles to strengthen process robustness and continuous improvement.
• Collaborate with Manufacturing, QA, QC, Regulatory Affairs, Procurement, and other internal functions to achieve project milestones.
• Interface with API and excipient manufacturers, equipment manufacturers, CROs, CMOs, and other external technical partners as required.
• Support Product Lifecycle Management and provide technical input into change controls affecting manufacturing documents, SOPs, protocols, and master records.
• Conduct preliminary technical assessments of new API opportunities and develop technical plans and implementation frameworks for selected candidates.
• Provide technical input into funding proposals, investment pitches, and business cases for future API development projects.
• Maintain project implementation plans covering milestones, dependencies, risks, and outstanding actions.
• Provide periodic progress reports to Management and promptly escalate technical, quality, resource, or timeline-related risks.

QUALIFICATIONS & EXPERIENCE

• Bachelor's degree or Master's degree in Pharmacy, Pharmaceutical Sciences, Chemical Engineering, Chemistry, Biochemistry, or a related scientific discipline.
• Relevant postgraduate qualification or professional certification in pharmaceutical manufacturing, process development, or a related field will be an advantage.
• Extensive experience in API research and development, pharmaceutical manufacturing, technology transfer, process validation, or a 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.

KEY COMPETENCIES

• Strong technical and scientific problem-solving skills.
• Excellent knowledge of API process development, technology transfer, and process validation.
• Strong understanding of GMP, QbD, risk management, and pharmaceutical quality systems.
• Excellent technical documentation and report-writing skills.
• Strong project management and milestone-tracking capabilities.
• Strong analytical, troubleshooting, and decision-making skills.
• Excellent cross-functional collaboration and stakeholder management skills.
• Ability to manage multiple technical activities and deliver within agreed timelines.
• Strong communication and presentation skills.
• Strategic thinking with the ability to identify and evaluate new API development opportunities.

WHAT WE OFFER

• Competitive salary and performance-based bonuses.
• A supportive and dynamic work environment with clear career growth opportunities.
• Comprehensive medical insurance, pension, and other employee benefits.