Senior Scientist - Biosimilars ARD

Description Summary A Sr. Scientist I will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instruments that include HPLC, UPLC, GC, UV/Vis, dissolution apparatus and particle analyzer. You will be expected to develop a close working relationship with technical personnel at all levels within the organization to provide technical support needed in meeting R&D milestones and goals. Conduct instrument troubleshooting or designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data. Essential Duties & Responsibilities Develop and validation analytical method for drug substances, drug products, and excipients Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance. Write protocols, reports, methods, standard operation procedure, and submission documents. Provide analytical support for formulation and process development. Perform independent scheduling and coordination of activities Complies with all company policies and standards Analyze analytical data, identify trends and provide recommendation. Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings Train and provide technical guidance to junior scientists. Conduct laboratory investigation and prepare laboratory investigation report. Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system. Evaluate and improve existing test methods Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection. Performs other functions as required or assigned Requirements

PREREQUISITES

Education: Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experience Or Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometry Or Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometry Experience A strong theoretical understanding and experience in protein chemistry and biochemistry. In-depth hands‑on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required. An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirements Excellent communication and technical writing skills Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment Strong experience in analytical method development and validation Demonstrated skills as a team-player and team-management. Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude. Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS. Ability to work under pressure and meet deadlines

SPECIALIZED KNOWLEDGE AND SKILLS

Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook. Experience with Mass Spectrophotometer is required. Experience with Empower HPLC software programs is required. #J-18808-Ljbffr Kashiv Biosciences LLC