Job Description

Responsibilities:

• Proactively and successfully oversee formulators, R&D analysts, and R&D teams in the planning, organizing, and carrying out of R&D projects and the drug development process.
• Verify that project management is in line with the stated goals of the organization.
• Create reliable formulas and procedures; - Execute pre-show and exhibit batches; - Scale up and transfer technology from R&D to production and the QC department to meet deadlines and budgets; - Scale up and optimize the manufacturing process.
• Arrange and participate in the scientific/technical tasks associated with the project (e.g., interpreting results, critically evaluating data, drawing pertinent conclusions, and writing reports).
• Develop and check SOPs and product milestones for accuracy and completeness, as well as for compliance with GMP requirements. - Examine pertinent documents and test findings.
• Taking appropriate action and making choices, including managing issues for all R&D projects across scientific disciplines.
• Execute product portfolios and change controls related to manufacturing and packaging master records, SOPs, procedures, and any other pertinent documentation in concert with other cross-functional teams.
• Prepare documentation for regulatory reasons, work with RA to coordinate the filing of drug dossiers and variations and correct any shortcomings; promptly provide RA with the pertinent documents for the filing of drug dossiers and variations.
• Using design of experiments (DOE), create reliable lab-scale, pilot-scale, and commercial-scale manufacturing processes based on Quality by Design (QbD) principles. Suggest appropriate approval criteria for each level. Use PAT where it is practical. As needed, apply pertinent statistical tools.
• Oversee, examine, and contest the project budget plan; keep an eye on spending as necessary.
• Assess patents and create non-infringement plans.
• Communication as needed with outsourcing product developers and laboratories, CROs, CMOs, and API manufacturers.

Requirements:

• Graduated from a bachelors or masters degree in pharmacy or related field.
• 8 years of experience in producing medications.
• 6 years of experience in the role of R&D manager.
• Understanding of PIC/S GMP and pharmaceutical quality standards, such as ICH and ASEAN Guidelines.
• Strong documentation and technical writing abilities are required.
• Strong leadership, strategic thinking, and communication abilities.
• Good command of English.
• Ability to relocated to work at Chiang Rai, Thailand