Chromatography and Stability

6 months ago

Malkajgiri Hyderabad Telangana, India Amogen Pharma Private Limited Full time

As a Senior Chromatography and Stability Scientist, you will be responsible for overseeing chromatographic analyses and stability studies within the organization. Your primary duties will include designing, executing, and interpreting chromatographic experiments to support product development and ensure product stability. You will collaborate closely with cross-functional teams to troubleshoot analytical issues, optimize methods, and drive continuous improvement initiatives.

**Key Responsibilities**:

- Design and execute chromatographic experiments using techniques such as HPLC and GC to analyze pharmaceutical compounds and products.
- Conduct stability studies to assess the shelf-life and degradation pathways of drug substances and drug products.
- Interpret chromatographic data and communicate findings effectively to internal stakeholders and regulatory authorities.
- Collaborate with R&D, Quality Control, and Manufacturing teams to ensure timely delivery of analytical results and support product development activities.
- Troubleshoot analytical challenges and propose solutions to optimize methods and improve assay performance.
- Maintain accurate and comprehensive records in compliance with regulatory requirements and company policies.
- Stay updated with emerging trends and advancements in chromatography and stability testing methodologies.

**Requirements**:

- Bachelor's or Master's degree in Chemistry, Analytical Chemistry, or related field.
- Minimum 6-8 years of hands-on experience in chromatographic analysis, particularly with HPLC and GC instrumentation, in a pharmaceutical or biotechnology industry setting.
- Proficiency in method development, validation, and troubleshooting for HPLC and GC techniques.
- Strong understanding of stability testing principles and regulatory requirements (e.g., ICH guidelines).
- Excellent analytical and problem-solving skills, with the ability to interpret complex data and propose actionable recommendations.
- Effective communication skills, both verbal and written, with the ability to collaborate across multidisciplinary teams.
- Detail-oriented approach with a commitment to maintaining high-quality documentation and adherence to Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP).
- Proven ability to work independently, manage multiple priorities, and meet deadlines in a fast-paced environment.

**Benefits**:

- Food provided
- Leave encashment
- Paid sick time
- Provident Fund

Schedule:

- Morning shift
- Rotational shift

**Experience**:

- total work: 1 year (preferred)

Work Location: In person

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