We are looking for R&D Pharma Team Leader to be responsible for the professional and managerial leadership of R&D pharma team engaged in formulation and process development of drug products. The role includes building and executing work plans, managing timelines, providing scientific expertise of formulation and manufacturing process development, scale-up activities, transition of products from development to commercial manufacturing, leading process validations and technology transfers and supporting ongoing commercial manufacturing through deviation investigations and professional assessments, while continuously driving operational efficiency within the department.
Responsibilities
Serve as a subject matter expert in formulation development, scale-up, and manufacturing processes.
Assign tasks, prioritize activities, and perform continuous follow-up on execution.
Ensure high-quality scientific and technical deliverables in compliance with GMP and regulatory standards.
Lead formulation and manufacturing process development in accordance with QbD methodology. Definition of QTPP, CQAs, CPPs, and Design Space.
Evaluation of experimental work, including scale-up activities from laboratory scale to Engineering to registration batches scale.
Lead and support process validation activities (Process Validation, PPQ). Review, assess, and approve validation protocols and reports.
Lead and participate in pharmaceutical technology transfer projects and transition of drug products from development status to commercial manufacturing, ensuring process robustness, regulatory readiness, and manufacturing continuity.
Collaborate with QA, Regulatory Affairs, Manufacturing, and Engineering to ensure successful product commercialization.
Identify risks, delays, and resource gaps, and lead mitigation actions.
Provide regular progress updates to management.
Actively participate in deviation investigations related to products in routine manufacturing and provide professional pharmaceutical opinions and assessments.
Perform root cause analysis and support definition and implementation of CAPAs.
Support change control activities related to products and processes.
Initiate and lead continuous improvement and efficiency initiatives within the department.
Implement pharmaceutical and regulatory best practices.
Responsibilities
Serve as a subject matter expert in formulation development, scale-up, and manufacturing processes.
Assign tasks, prioritize activities, and perform continuous follow-up on execution.
Ensure high-quality scientific and technical deliverables in compliance with GMP and regulatory standards.
Lead formulation and manufacturing process development in accordance with QbD methodology. Definition of QTPP, CQAs, CPPs, and Design Space.
Evaluation of experimental work, including scale-up activities from laboratory scale to Engineering to registration batches scale.
Lead and support process validation activities (Process Validation, PPQ). Review, assess, and approve validation protocols and reports.
Lead and participate in pharmaceutical technology transfer projects and transition of drug products from development status to commercial manufacturing, ensuring process robustness, regulatory readiness, and manufacturing continuity.
Collaborate with QA, Regulatory Affairs, Manufacturing, and Engineering to ensure successful product commercialization.
Identify risks, delays, and resource gaps, and lead mitigation actions.
Provide regular progress updates to management.
Actively participate in deviation investigations related to products in routine manufacturing and provide professional pharmaceutical opinions and assessments.
Perform root cause analysis and support definition and implementation of CAPAs.
Support change control activities related to products and processes.
Initiate and lead continuous improvement and efficiency initiatives within the department.
Implement pharmaceutical and regulatory best practices.
Requirements:
Bachelors degree (required) in Pharmacy, Chemistry, Chemical/Biomedical/ Biotechnology Engineering.
6-10 years of experience in the pharmaceutical industry- mandatory.
Prior experience in technology transfer within the pharmaceutical industry – mandatory.
People management experience – mandatory.
Proven experience in formulation and manufacturing process development using QbD.
Hands-on experience with process validation, technology transfer, scale-up activities and transition from development to commercial manufacturing- mandatory.
Solid understanding of pharmaceutical manufacturing processes at development and commercial scale
Strong knowledge of GMP and regulatory requirements (IMOH, FDA, EMA)
Experience in reviewing and approving protocols, reports, and technical documentation.
Strong analytical, problem-solving, and decision-making capabilities.
Strong organizational and planning skills.
Ability to work under pressure and manage multiple priorities. Excellent communication skills.
Bachelors degree (required) in Pharmacy, Chemistry, Chemical/Biomedical/ Biotechnology Engineering.
6-10 years of experience in the pharmaceutical industry- mandatory.
Prior experience in technology transfer within the pharmaceutical industry – mandatory.
People management experience – mandatory.
Proven experience in formulation and manufacturing process development using QbD.
Hands-on experience with process validation, technology transfer, scale-up activities and transition from development to commercial manufacturing- mandatory.
Solid understanding of pharmaceutical manufacturing processes at development and commercial scale
Strong knowledge of GMP and regulatory requirements (IMOH, FDA, EMA)
Experience in reviewing and approving protocols, reports, and technical documentation.
Strong analytical, problem-solving, and decision-making capabilities.
Strong organizational and planning skills.
Ability to work under pressure and manage multiple priorities. Excellent communication skills.
This position is open to all candidates.
