Analytical Research Development Executive/ Assistant Manager

Themis Medicare Limited; Hyderabad; On-site; INR 1,100,000 - 1,900,000; Full time

Job summary

Themis Medicare Limited in Hyderabad, India is seeking an experienced Analytical R&D professional to develop and validate methods using HPLC for APIs, in-process and finished products. You will work with formulation development to optimize products based on analytical findings.

The role requires 7–10 years in AR&D or related fields, with a strong grasp of GLP, cGMP, QC principles and regulatory requirements to ensure compliant testing and documentation.

Qualifications

• 7–10 years of AR&D or similar experience.
• B.Pharm or B.Sc from a recognized university.
• Strong understanding of GLP, cGMP, QC principles and regulatory requirements.

Responsibilities

• Develop analytical methods for API, in-process samples, and finished products using HPLC.
• Conduct method validation studies according to ICH guidelines and company SOPs.
• Collaborate with formulation development to optimize product formulations based on analytical results.
• Ensure compliance with regulatory requirements by maintaining accurate records of testing procedures and protocols.
• Troubleshoot issues related to instrument maintenance, data analysis, and reporting.

Skills

AR&D experience

HPLC proficiency

Regulatory knowledge

Education

B.Pharm or B.Sc

Job description

Roles and Responsibilities

• Develop analytical methods for API, in-process samples, and finished products using HPLC techniques.
• Conduct method validation studies according to ICH guidelines and company SOPs.
• Collaborate with formulation development team to optimize product formulations based on analytical results.
• Ensure compliance with regulatory requirements by maintaining accurate records of testing procedures and protocols.
• Troubleshoot issues related to instrument maintenance, data analysis, and reporting.

Desired Candidate Profile

• 7-10 years of experience in Analytical Research & Development (AR&D) or similar field.
• Bachelor's degree in Pharmacy (B.Pharma) or Science (B.Sc), preferably from a recognized university.
• Strong understanding of Good Laboratory Practices (GLP), Current Good Manufacturing Practice (cGMP), Quality Control principles, and regulatory requirements.