R&d Manager

**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.
- 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