Position Overview:

We are seeking an experienced and results-driven R&D Analytical Coordinator to lead a team scientist in our R&D department. The successful candidate will be responsible for planning and overseeing analytical activities, ensuring seamless coordination with the R&D formulation team and other departments such as Quality Control (QC). The analytical team is involved in a variety of tasks, including analytical methods development and validation, raw materials analysis and release, stability studies, process validation, definition of specifications, 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 analytical activities to ensure timely and accurate results.

- Prepare comprehensive documentation for submission to regulatory authorities.

- Coordinate with the R&D formulation 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 analytical methods development and validation.

- Experience in raw materials analysis, stability studies, and process validation.

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

- Good command of English.

- Good command of MS Office applications and Analytical software.

Qualifications:

- Graduated from Chemistry, Chemical Engineering, or related departments of universities,

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

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