Executive, Method Development - Extractable & Leachable | OSD

Amneal Pharmaceuticals

3 - 5 years

0 Lacs

ahmedabad

Posted:1 day ago| Platform: GlassDoor logo

Apply

Skills Required

development packaging extraction analysis instrumentation testing compliance report data reports documentation calibration maintenance polymer risk assessment troubleshooting interpretation communication diversity

Work Mode

On-site

Job Type

Part Time

Job Description

Key Responsibilities:

Conduct extractables and leachable studies on packaging components, medical devices, and drug products.
Perform sample preparation, extraction, and analysis using techniques such as HPLC , GC-MS, LC-MS, ICP MS , ICP OES and other relevant instrumentation.
Develop and validate analytical methods for E&L testing in compliance with regulatory guidelines (e.g., USP <1663>, <1664>).
Interpret and report analytical data, including identification and quantification of unknown compounds.
Prepare technical reports, protocols, and documentation for regulatory submissions.
Maintain laboratory instruments and ensure calibration and preventive maintenance schedules are followed.
Collaborate with cross-functional teams including formulation, regulatory affairs, and quality assurance.
Ensure compliance with GLP/GMP standards and laboratory safety protocols.

Additional Skills:

Experience with polymer chemistry and material characterization.
Familiarity with toxicological risk assessment and safety thresholds, if possible

Qualifications and Experience

M.Sc. / M. Pharm / Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field.
3-5 years of experience in extractables and leachable testing.
Proficiency in HPLC, GC-MS, LC-MS, ICP MS , ICP OES and other analytical techniques.
Strong understanding of regulatory requirements for E&L studies.
Experience in method development, validation, and troubleshooting.
Excellent documentation, data interpretation, and communication skills.

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

More Jobs at Amneal Pharmaceuticals

Manager, Packaging

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Associate

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Executive, EH&S

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.