Analytical Scientist
Summary:
Seeking a highly skilled and experienced Senior Analytical Scientist. The ideal candidate will provide scientific and technical leadership in the selection and implementation of analytical techniques, conduct laboratory activities towards the development, verification, optimization, transfer, and validation of stage-appropriate analytical methods, and draft and review scientific documents for global regulatory authorities.
Key Responsibilities:
- Independently conduct standard and advanced laboratory activities.
- Perform liquid chromatography (LC), spectroscopy, and aerosol performance characterization studies for OINDPs.
- Conduct physico-chemical and aerosol analytical characterization of OINDPs.
- Evaluate and select raw materials (APIs, excipients, packaging materials, device components) and conduct pre-formulation, formulation, and process development studies following cGMPs and EH&S guidelines.
- Analyze and summarize analytical data using advanced tools, including statistical packages, and identify trends and make recommendations.
- Draft high-quality protocols, methods, reports, SOPs, and submission documents.
- Execute analytical activities required for regulatory submission, including method development, verification, optimization, transfer, and validation.
- Present data analysis, recommendations, and conclusions to senior management.
- Communicate effectively with team members and internal/external customers.
- Troubleshoot technical issues, analyze data, identify solutions, and implement recommendations.
- Ensure lab work is conducted in accordance with SOPs and safety rules.
- Comply with all corporate guidelines and policies.
Qualifications:
- Ph.D. in Analytical Chemistry, Organic Chemistry, Pharmaceutics, or related fields with at least 3 years of experience; MSc with at least 5 years or BSc with at least 8 years of experience in pharmaceutical or related fields.
- Extensive knowledge of chromatography and spectroscopy-based analytical techniques, including HPLC, GC, UV, FTIR.
- Experience with analytical method development, verification, and validation.
- Strong technical writing skills and experience drafting scientific documents.
- Experience with OINDPs (e.g., DPI, MDI, nasal drug products) is a plus.
- Familiarity with USP methodologies, ICH guidelines, FDA, and cGMP requirements.
- Excellent English language skills, both written and oral.
FAQs
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