Lavipharm is seeking an R&D Analytical Scientist who will be responsible for carrying out assigned Method Development, Method Validation, Process Validation and Stability studies or any other analytical activity needed for the development of new products or analytical methods.

Job position reports to Lead R&D Analytical.

Responsibilities

1. Analytical Method Development & Execution:

• Executes analytical activities for pharmaceutical development ensuring accuracy and reliability.

• Assists in the development of new analytical methods or improvement of existing ones to improve efficiency and effectiveness.

• Executes analytical methods validation, following ICH guidelines and ensures proper documentation.

• Conducts stability studies (developmental and pivotal) to support new product development or lifecycle management.

• Works independently with minimal instruction and provide scientific insights for method development challenges.

• Analyzes experimental data, interprets outcomes, and recommends appropriate follow-up actions.

• Collaborates with cross-functional teams to facilitate analytical method transfers.

• Manages laboratory inventory and coordinate with suppliers to purchase timely availability consumables.

2. Documentation and Regulatory Support:

• Authors scientific documentation related to method development, validation, and stability studies.

• Maintains detailed records of research activities and provides progress reports when required.

• Assists in the preparation and review of regulatory dossier documentation for tech transfer projects and ASMF.

• Supports the creation of Module 3 sections for regulatory submissions to ensure compliance with global standards.

3. Process Optimization and Compliance:

• Follows established internal processes and actively suggests improvements.

• Ensures adherence to SOPs and GMP requirements

• Maintains knowledge of regulatory guidelines (ICH, EMA, or other relevant authorities) and apply them in research activities to ensure compliance

4. Clinical and In-vitro/Ex-vivo Studies Support:

• Contributes to clinical (Bioequivalence) studies, as well as in-vitro and ex-vivo experiments through IVPT using franc cells to support project goals

• Provide additional scientific input to enhance study outcomes and overall project success

Education:

• Bachelor of Science (BSc) in Chemistry, Pharmacy, or other relevant Health Sciences disciplines.

• Master of Science (MSc) in Analytical Chemistry, Industrial Pharmacy, Chemistry, Chemical Engineering, Biochemistry, or a related field is preferred.

Experience:

• A minimum of 1-2 years of experience in pharmaceutical analysis.

• Practical expertise with analytical instrumentation, including HPLC, GC, UV-Vis spectrophotometry, and dissolution testing.

• Prior experience with analytical method validation and technical documentation is an advantage.

Skills:

• Proficiency in Microsoft Office Suite, with a focus on Excel and statistical tools (e.g., Minitab or equivalent).

• Excellent data interpretation, problem-solving, and scientific writing skills.

• Familiarity with regulatory guidelines (ICH, EMA, etc.).

This position offers an opportunity to contribute to cutting-edge pharmaceutical research in a collaborative and dynamic environment. If you are driven by innovation and possess the required skills, we invite you to join our team.