Scientist, Quality Control
Amneal India
Summary
The Scientist II - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs, calculating and reporting results on applicable specification documents, participating in method transfer activities within departments or between facilities or organizations. Provides feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture.
Job description
Essential Functions
- Performs chemical analysis of raw materials, in-process and finished pharmaceutical products, including products on stability, according to written methods or compendial methods as applicable, material specifications, using analytical techniques such as IR spectroscopy, UV-Vis spectroscopy, and chromatographic techniques, adhering to company policies as identified in standard operating procedures (SOPs).
- Prepares samples for analysis involving thorough cleanliness and complex steps for analysis using chromatographic techniques and analyzes. Creates and maintains laboratory record documentation (notebooks and computer-based), documents exact steps followed during analysis execution, calculates and reports results in a timely manner.
- Actively participates in method transfer activities between facilities within the organization or between organizations.
- Actively participates in and leads investigation of out-of-specification laboratory results, when required.
- Performs physical analysis involving complex techniques such as X-ray diffraction, DSC, Malvern mastersizer.
- Prepares and executes method transfer protocols, method verification/validation protocols as and when required.
Additional Responsibilities
- Assists, as and when needed, senior scientists working in the laboratory.
- Ensures that expired chemicals and reference standards are removed from laboratory area, performs calibration of dissolution apparatus, FT-IR, UV-Vis spectrophotometer, HPLC, GC as assigned by the supervisor.
- Standardizes API for use as in-house reference standard as assigned.
- Interacts with newly hired laboratory technicians or Assistant Scientists for providing hands-on training on simple analytical techniques and laboratory instruments.
Requirements
- Bachelors Degree (BA/BS) Chemistry or related science discipline - Required
- Master Degree (MA/MS) Chemistry or related science discipline - Preferred
- 3 years or more in Bachelors Degree (BA/BS) - Testing of chemicals/pharmaceutical products
- 1 year or more in Master Degree (MA/MS) - Testing of chemicals/pharmaceutical products
Benefits
- Short-term incentive opportunity
- Performance-based award
Company overview
Amneal India is the Indian subsidiary of Amneal Pharmaceuticals, Inc., a leading U.S.-based global pharmaceutical company specializing in generic and specialty medicines. Established in India in 2008, Amneal has built a significant presence with over $300 million in capital investments and acquisitions. The company operates eight state-of-the-art, FDA-approved manufacturing and R&D facilities across Ahmedabad, Dahej, Vizag, and Hyderabad, employing more than 5,500 professionals in India. Amneal India focuses on producing high-quality essential medicines, including injectables, tablets, and specialty pharmaceuticals, with a collective capacity to produce approximately 60 million units of injectables and 8.5 billion tablets annually. The company has recently expanded its commercial operations in India, launching innovative specialty medicines in oncology, ophthalmology, diagnostics, and hospital care. Amneal's commitment to India includes plans for additional investments of up to $200 million to build two new manufacturing facilities in Ahmedabad for peptide synthesis and advanced sterile fill-finish manufacturing, further strengthening its position as a key player in the global pharmaceutical supply chain.