Job Title: Senior Officer – Analytical Method Development
Summary:
Acme Group, a rapidly expanding pharmaceutical organization in India, is seeking a highly motivated and experienced Senior Officer to join our Analytical Method Development team in Ahmedabad, Gujarat. This role offers an excellent opportunity for an individual with a strong foundation in analytical chemistry and a passion for developing and validating analytical methods for solid oral dosage forms. The successful candidate will contribute to the development of high-quality pharmaceutical products while working in a modern, supportive, and growth-oriented environment.
About Acme Group:
Acme Group is a dynamic and innovative pharmaceutical company committed to developing, manufacturing, and marketing high-quality pharmaceutical products. We are dedicated to improving patient health and well-being through our relentless pursuit of excellence in pharmaceutical research and development. Our state-of-the-art facilities and experienced team make Acme Group a rewarding and challenging place to build a career.
Job Description:
As a Senior Officer – Analytical Method Development, you will be responsible for the development, validation, and transfer of analytical methods for solid oral dosage forms. You will work closely with formulation development, QA/QC teams, and other stakeholders to ensure the quality and compliance of our products.
Key Responsibilities:
- Develop and validate robust and reliable analytical methods for solid oral dosage forms (tablets, capsules) in accordance with ICH guidelines and regulatory requirements.
- Perform forced degradation studies to establish impurity profiles and assess the stability of drug substances and products.
- Independently operate and maintain analytical instruments, including HPLC, UV, Dissolution, GC, and IR.
- Prepare comprehensive method development reports, validation protocols, and technology transfer documents.
- Ensure strict adherence to ICH guidelines, USP standards, and current regulatory requirements throughout the method development and validation process.
- Troubleshoot analytical issues arising during routine analysis and stability studies, and propose effective solutions.
- Collaborate effectively with formulation development teams to understand product characteristics and develop appropriate analytical methods.
- Coordinate with QA/QC teams to ensure seamless transfer of validated methods for routine testing and quality control.
- Maintain accurate and well-organized documentation, adhering to Good Documentation Practices (GDP) and data integrity principles.
- Contribute to the continuous improvement of analytical processes and procedures.
Qualifications & Experience:
- M.Sc in Chemistry / M.Pharm / B.Pharm from a recognized university.
- 1 to 2 years of hands-on experience in Analytical Method Validation (AMV) specifically related to solid oral dosage forms.
- Demonstrated expertise in HPLC method development and validation techniques.
- Thorough understanding of 21 CFR compliance requirements and data integrity practices.
- Proficient in preparing SOPs, validation protocols, and comprehensive reports.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently and as part of a team in a fast-paced environment.
Salary & Benefits:
- Competitive salary range: ₹4.2 – 6.8 LPA (commensurate with experience and interview performance).
- Comprehensive benefits package including Provident Fund, gratuity, health insurance, and performance-based bonus.
- Company-provided transportation (Cab facility).
- Subsidized canteen for meals.
- Modern and well-equipped work environment.
- Opportunities for professional growth and career advancement within a dynamic organization.
How to Apply:
Interested and qualified candidates are encouraged to submit their updated resume to [email protected]. Please clearly mention “Senior Officer – Analytical Method Development” in the subject line of your email.
Contact Information:
For inquiries regarding this position, please contact us at +91 72270 26128.
Location:
Ahmedabad, Gujarat (Work from Office Only)
Application Deadline:
Apply within 10 days for priority processing.
We look forward to receiving your application and potentially welcoming you to the Acme Group team!