Study Director

Accuprec Research Labs; Ahmedabad District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Accuprec Research Labs in India is seeking a capable lead to head analytical and bioanalytical studies, ensuring compliance with international guidelines and data integrity. The role involves overseeing method validation, chemical characterization, E&L work, and pharmacokinetic studies while upholding rigorous lab standards.

You will review data, protocols, and reports, and guide junior team members to maintain high data quality and regulatory compliance in a fast-paced laboratory environment.

Qualifications

• Master's degree in Pharmacy or Sciences (M.Pharm / M.Sc) required.
• Experience with analytical method validation and regulatory guidelines preferred.
• Familiarity with ICH Q2, ISO standards and pharmacokinetic studies advantageous.

Responsibilities

• Conduct analytical method validation (ICH Q2).
• Perform chemical characterization studies (ISO standards).
• Execute extractables & leachables (E&L) studies.
• Manage bioanalytical and pharmacokinetic studies (ICH M10).
• Review data, protocols, and reports.
• Guide junior team members and maintain lab standards.

Education

M.Pharm / M.Sc

Job description

M.Pharm / M.Sc

Lead analytical and bioanalytical studies while ensuring compliance with international guidelines and maintaining high data integrity.

Key Responsibilities

• Conduct analytical method validation (ICH Q2)
• Perform chemical characterization studies (ISO standards)
• Execute extractables & leachables (E&L) studies
• Manage bioanalytical and pharmacokinetic studies (ICH M10)
• Review data, protocols, and reports
• Guide junior team members and maintain lab standards

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