31 Jul
|
Althera Laboratories India, Bangalore
|
Karnataka
31 Jul
Althera Laboratories India, Bangalore
Karnataka
We are seeking an accomplished and highly experienced scientific qualified with at least 15 years of relevant bioanalytical and regulatory experience described above, and possess the capability to provide scientific and regulatory oversight of bioanalytical studies, protocols, and study reports.
Key Responsibilities
- Provide scientific and regulatory oversight for bioanalytical studies supporting preclinical and clinical development.
- Review, approve, and provide scientific guidance on bioanalytical study protocols, method validation protocols, study plans and analytical reports.
- Lead scientific review of bioanalytical method development, validation, sample analysis and data interpretation.
- Ensure quality, accuracy, integrity and regulatory compliance of bioanalytical data and documentation.
- Review and approve deviation investigations, CAPAs, change controls and scientific justifications.
- Stay updated with evolving global bioanalytical regulations, industry trends and scientific advancements.
Qualifications
- PhD in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry, Pharmacology, Biotechnology, Life Sciences or a related discipline (mandatory).
📌 Senior Scientific Manager (Bio-Analytical) (Karnataka)
🏢 Althera Laboratories India, Bangalore
📍 Karnataka