Analytical Scientist II

Provides support for the development and validation of pharmaceutical analytical methods such as potency, dissolution, impurities/degradation products, and residual solvents using appropriate laboratory instrumentation, including HPLC, UHPLC, LC-MS, Dissolution Apparatus, and GC. Supports formulation development activities by testing development samples, clinical samples, and stability samples. Develops and evaluates analytical test methods for raw materials, in-process products, and finished products. Conducts and documents chemical and physical testing of finished products, raw materials, active pharmaceutical ingredients, and stability samples to support new product formulation development for both ANDA and NDA projects. Performs method verification and method validation in accordance with approved method validation protocols, company standard operating procedures (SOPs), FDA Guidance, and ICH Guidelines. Conducts and documents in-process and finished product testing for product release and stability as per the approved test methods. Attends SOP, safety, and scientific trainings to remain current with cGMP regulations and safety standards. Authors experimental protocols, reports summarizing experiment findings, and revisions of testing methods and SOPs. Oversees equipment calibrations and repairs from internal or external partners, coordinating timing and expectations. Troubleshoots equipment and testing methods while optimizing and developing new testing approaches. Conducts peer data review and mentors new employees on instruments and test methods. Performs complex testing, such as multistage dissolution. Attends client meetings and manages client interactions.

Requirements:

- Bachelor's degree in chemistry, pharmaceutical sciences, or related field, and five years of experience in a pharmaceutical laboratory.

- Alternatively, master's degree in chemistry, pharmaceutical sciences, or related field, and two years of experience in a pharmaceutical laboratory.

- Proficiency with cGMP, ICH, and FDA compliance.

- Experience in small molecular chemical synthesis, API manufacturing and process development of generic meeting FDA guidance, and pharmaceutical manufacturing per cGMP procedures.

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- Experience in analytical method development/validation such as HPLC, UPLC, GC, TGA, DSC, Ultraviolet-visible (UV), Spectrophotometer, FTIR, or NMR under GMP environment.