Senior Scientist, Quality Control

Amneal Pharmaceuticals; Piscataway Township (NJ); On-site; USD 115,000 - 120,000; Full time

Benefits offered by this job

Equal opportunity employer

Job summary

Amneal Pharmaceuticals in Piscataway, NJ is seeking a Senior Scientist, Quality Control to perform testing of raw materials, in-process and finished dosage forms, and stability samples, reporting results and supporting method transfers. You will calibrate instruments and ensure data integrity according to SOPs.

Role requires cGMP understanding, experience with HPLC/GC/UV-Vis and dissolution, and active participation in investigations and continuous improvement efforts.

Qualifications

• In-depth knowledge of analytical chemistry techniques including spectrophotometric, dissolution and chromatographic methods.
• Ability to follow compendial USP/EP/BP/JP procedures for analysis.
• Understanding and application of cGMP requirements in QC laboratories.
• Ability to troubleshoot complex analytical/instrument problems and report findings promptly.
• Identify trends in analytical data and communicate results clearly.

Responsibilities

• Perform testing of raw materials, in-process and finished pharmaceutical dosage forms and stability samples.
• Calculate and report results on applicable specifications and SOPs; support method transfers.
• Calibrate instruments (HPLC, GC, UV detectors) and maintain calibration records.
• Investigate abnormal results and assist with non-routine projects or investigations.
• Assist in training new Technicians and Scientists on analytical techniques.

Skills

Analytical chemistry

HPLC/GC/UV-Vis

cGMP compliance

Data trend analysis

Method validation

Education

Bachelor's degree in Pharmacy or Chemistry

Tools

HPLC

GC

UV-Vis spectrophotometer

Karl Fischer

IR spectrophotometer

Dissolution testing

Job description

Job Description

Senior Scientist, Quality Control: 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, calculate and report results on applicable specification documents, participate in method transfer activities within departments or between facilities or organizations. This role will also provide feedback on systems and analytical procedures to promote continuous improvement and enhancement of compliance posture. Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs). Comply with cGMps, SOPs, and STPs to avoid out-of-specification situation. Assure compliance with state and federal regulations. Actively participate in any project work as and when assigned. Perform process validation and cleaning validation/verification testing on various drugs. Assist other scientists with analytical, instrument and software related problems as required. Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution. Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and /or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator. Document steps followed during analysis execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for completeness, specification compliance, and compliance with company’s written policies. Report any abnormal findings to the Supervisor. As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications. Assist the laboratory supervisor with handling non-routine special projects requiring activities such as out-of-specification investigations and out-of-alert limit investigations in the laboratory. Ensure that expired chemicals and reference standards are removed from laboratory area. Perform calibration of HPLC, GC, and other equipment as assigned by the supervisor. Assist with hands-on training of newly hired Technicians or Scientists 1 and 2 levels.

Job Location: Piscataway, NJ.

Salary: $115K - $120K per annum.

Hours: 40 hrs/wk 8:30am - 5:30pm

Location: Piscataway

Qualifications

• Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).
• Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Must understand and apply cGMP requirements applicable to quality control laboratory.
• Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
• Must be able to identify trends in analytical data.
• Must have at least a Bachelor’s degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing.
• Must have 60 months of experience in the position or in a related position.

About Us

Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at [e-mail] . Requests will be handled confidentially and in accordance with applicable laws.