Position Overview:

We are seeking an experienced and results-driven R&D Formulation Coordinator to lead a team of scientists in our R&D department. The successful candidate will be responsible for planning and overseeing formulation activities, ensuring seamless coordination with the R&D analytical team and other departments such as Production, Supply-Chain, and Engineering. This role involves a variety of tasks, including formulation development, process optimization, scale-up, and preparation of documentation for regulatory submissions.

Key Responsibilities:

- Lead and manage the analytical team, fostering a collaborative and high-performance work environment.

- Plan, prioritize, and oversee daily formulation activities to ensure timely and successful project outcomes.

- Develop and optimize formulations for new and existing products.

- Conduct scale-up studies and process optimization to ensure robust and reproducible manufacturing processes.

- Prepare comprehensive documentation for submission to regulatory authorities.

- Coordinate with the R&D analytical team and other departments to ensure alignment and efficient workflow.

- Support the team in responding to Deficiency Letters from regulatory authorities.

- Ensure compliance with US and EU regulatory requirements (GxP).

- Participate in budgeting processes.

- Identify areas for improvement and contribute to the growth plan: technical and competency-based development areas and training needs.

- Report to the R&D Manager on project progress, challenges, and solutions.

Required Competencies:

- Proven experience in leading and managing a scientific team.

- Strong organizational skills with the ability to prioritize work effectively.

- Excellent communication skills, both written and verbal, with the ability to clearly convey information to team members and other departments.

- In-depth knowledge of US and EU regulatory requirements for pharmaceuticals (GxP).

- Proficiency in formulation development and process optimization.

- Experience in scale-up studies and manufacturing process development.

- Ability to prepare detailed and accurate documentation for regulatory submissions.

- Good command of English.

- Good command of MS Office applications.

Qualifications:

- Graduated from Pharmacy, Chemistry or Chemical Engineering departments of universities, preferably with a master's degree

- Minimum of 5 years of experience in pharmaceutical R&D, with a focus on formulation development.

- Preferably with experience in developing products for EU and US markets.