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SalaryJob Description
Job Scope
R&D is responsible for pharmaceutical product development and associated activities. This position is responsible for working with cross-functional departments such as Manufacturing, QA, QC ,Regulatory Affairs, and Portfolio Management. Job entails developing robust products and processes that are scalable, stable, and bioequivalent to the reference Product. This is a leadership position that requires the candidate to be acquainted with current practices and trends within the industry to meet compliance and keep up with technology.
Roles & Responsibilities
- Lead and manage a team of researchers and scientists, overseeing the planning and execution of research projects for the development of new drugs .
- Plan and contribute to project-related scientific/technical activities (e.g., interpret results, critical assessment of data, draw relevant conclusions, and write reports).
- Work proactively with other cross-functional groups to execute change controls associated with Manufacturing and Packaging master records, SOPs and protocols.
- Scale up and technology transfer from R&D to production to meet timelines.
- Author technical documents including Product Development Report, Quality Overall Summary, and other relevant documents for regulatory filing purpose.
- Create and review SOPs, as well as review appropriate documentation and test results for accuracy and completeness and compliance with SOPs requirement.
- Stay updated with industry trends, regulations, and advancements in pharmaceutical research to identify new opportunities for innovation and growth.
- Conduct regular market analysis and competitor research to inform strategic decision-making.
- Facilitate effective communication and knowledge sharing among team members and stakeholders.
- Ensure the effective utilization of budgets and resources, monitoring project expenses, and making strategic decisions to optimize efficiency and productivity.
- Responsible and accountable for the internal product development pipeline and will manage and oversee personnel involved in project specific implementation and execution of planned development activities.
- Responsible for development project planning/strategy and project management across multiple approved company projects at any one time according to timelines and budget parameters.
- Work closely with the Scientific, Clinical and Medical Affairs Department .
- Responsible for promoting a culture of innovation both within the Research, Development, and Innovation Department and across the business.
- Set project direction, planning, goals, milestones and ensure project deliverables meet strategic corporate objectives.
- Deliver projects within the planned timelines.
- Lead R&D’s projects overall risk assessment and issue management.
- Source and evaluate the capabilities and qualifications of contract developers/ manufacturers to prepare/process the intended formulation.
Qualifications & Work Experience
- Bachelor Degree of Pharmacy is a must.
- Educated to master’s level / PhD in Chemistry, pharmacy; must be technically competent.
- Min 10 years of experience in the pharmaceutical industry.
- R&D experience and successful track record is a must.
- A strong understanding of drug development processes, regulatory requirements, and industry trends is essential for effectively managing R&D projects.
- R&D manager must possess the analytical skills to evaluate complex scientific data, draw meaningful conclusions, and make informed decisions to further research initiatives.
- R&D manager need to communicate research findings, project updates, and strategic recommendations to stakeholders at various levels
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