Scientist, Quality Control

Amneal Pharmaceuticals is seeking a Scientist II - QC to support pharmaceutical quality control testing and laboratory compliance. The role performs chemical and physical analyses of raw materials, in-process and finished products, manages analytical documentation and results, and participates in method transfers, validations, and investigations.

Responsibilities

• 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
• 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

Preferred

• Master's degree (MBA) Chemistry or related science discipline - Preferred
• Master's Degree
• MBA
• Science Discipline

Benefits

• For eligible positions, above-market, diverse and robust health and insurance benefits to meet the varied needs of employees
• For eligible positions, a significant 401(k) matching contribution to help employees save for retirement
• Employee well-being programs that support balancing career with life’s other commitments and opportunities

Company

• Biopharmaceutical company developing generics, injectables, biosimilars, and specialty medicines
• Bridgewater, New Jersey, USA
• http://amneal.com/
• Founded in 2002
• 5001-10000 employees

Qualifications

• Bachelor's Degree (BA/BS) Chemistry or related science discipline - Required
• With Bachelor's Degree (BA/BS) -Testing of chemicals/pharmaceutical products, 3 years or more
• With Master's degree (MA/MS) -Testing of chemicals/pharmaceutical products, 1 years or more
• This position requires successful completion of an OSHA-compliant Respirator Fit Test
• Master's degree (MBA) Chemistry or related science discipline - Preferred

Required skills

• Pharmaceutical Testing

Experience

• 1+ years