We are currently seeking a Senior Chemistry Specialist who will coordinate and conduct pharmaceutical test/analysis and studies. This person will also coordinate/manage pharmaceutical development projects and provide supervision to junior personnel if needed.
1. Coordinates/manages pharmaceutical development projects such as feasibility stability studies, material qualification and delivers the results within the defined time deadlines.
2. Develops and validates analytical test methods, particularly the HPLC methods.
3. Conducts hands-on experiments or work as necessary to solve problems and provides technical guidance to team members on routine and special tasks.
4. Authors, reviews and approves study protocols, reports and any other documents related to analytical methods development and validation, feasibility study, material qualifications, and technical investigations.
5. Designs validation and investigation strategies.
6. Reviews work, results, data, reports and any other documents generated by others for
compliance to current requirements.
7. Supervises activities related to contract services.
8. Assists in writing the CMC for regulatory submissions, interaction with FDA center and local districts.
9. Reviews and/or develops specifications for new components and products for suitability with manufacturing systems.
10. If needed, acts as Team Leader supervising and guiding all activities associated with Methods Development, Methods Validation Formulation Development, Raw Material Qualification, and New Product Feasibility.
To qualify, candidates must possess:
- Ph.D in Chemistry or related fields with about 8 years experiences or MS with over 15 years experiences in pharmaceutical industry.
- Basic understanding and experience in formulating parenteral injectables. Basic understanding of manufacturing processes.
- In-depth understanding of different technologies in chemical analyses in pharmaceutical developments, such as: wet chemistry, HPLC, GC, MS, FT-IR, UV-VIS, Polarimetry, AA and of general laboratory techniques and practices.
- Strong knowledge of cGMP, USP, ICH, AOAC, and EP guidelines.
- Understanding of the pharmaceutical development system and processes.
- Excellent written and verbal English skills with experiences in writing protocols, reports, and proposals.
- Proven good organizational/leadership skills.
- Good communication and interpersonal skills.
- Submission experience is highly desirable.
State or Province