Job Description

The Senior Scientist, Analytical Chemistry fulfills a critical role in supporting the analytical development and validation/verification and method transfer of testing methods for the Quality control laboratory, to characterize drug substance, raw materials, and drug products. The individual is a part of the Quality Control Technical Services team which develops, validates/verify, and qualifies testing methods for active pharmaceutical ingredients, excipients and dosage forms, including troubleshooting and lifecycle management of analytical methods. Perform release testing of API, Excipients/raw materials, In-process and Finished products and stability study, cleaning verification samples following written procedures and applicable SOPs, calculate and report results on applicable specification documents.

Essential Functions:

• Develop and validate analytical methods (mostly LC and GC) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical laboratory for routine analysis. Development and optimization of new and existing analytical methods for qualification, release testing of products.
• 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.
• 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.
• Provide timely responses to internal and external inquiries.
• Provide training and guidance to laboratory analysts and group members aimed at developing technical capabilities. Expand analytical capabilities of the Analytical Group.
• Ensure that procedures are technically developed and conform to appropriate standards of identity, strength, quality, purity of components. 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.
• Evaluate, recommend and implement new analytical technologies and instrumentation for testing

Additional Responsibilities:

• Stays abreast of new developments in analytical technologies. Contributes to improvement in laboratory operations to increase efficiency and GMP compliance.
• Leads team members on assigned projects, as required.
• Participates and leads scientific discussions on projects with cross-functional team.

Education:

• Bachelors Degree (BA/BS) in chemistry or other relevant pharmaceutical sciences - Required
• Master Degree (MS/MA) in chemistry or other relevant pharmaceutical sciences - Preferred

Experience:

• 5 years or more in pharmaceutical experience (with Bachelor's Degree)
• 4 years or more in pharmaceutical experience (with Masters Degree)

Specialized Knowledge:

• Broad knowledge of modern analytical equipment and techniques. Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques 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. Extensive experience in cGMP laboratory testing of pharmaceuticals.
• Hands-on experience with HPLC, GC, Dissolution Apparatus, UV Spectrophotometer, FTIR, TLC, and MS.
• Method development and validation experience.
• Experience writing the standard operating procedures (SOPs) and test methods.
• Experience with regulatory document compilation.

The base salary for this position ranges from $90,000 to $123,000 per year. In addition, Amneal offers a short-term incentive opportunity, such as a bonus or performance-based award, with this position within the first 12 months. Amneal ranges reflect the Company’s good faith estimate of what Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.

At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.

Amneal is an Equal Opportunity Employer that does not discriminate on the basis of sex, age, race, color, creed, religion, national origin, sexual orientation, gender identity, genetic information, disability, veteran status, liability for service in the U.S. Armed Forces or any other characteristic protected by applicable federal, state, or local laws.