Senior Scientist - Biosimilars ARD

About the role

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.

Responsibilities

• Develop and validate 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 procedures, and submission documents
• Provide analytical support for formulation and process development
• Independently schedule and coordinate activities
• Comply with all company policies and standards
• Analyze analytical data, identify trends, and provide recommendations
• 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 investigations and prepare laboratory investigation reports
• Proactively provide Lab management with suggestions on how to improve methods, lab practices, or lab systems
• Review and evaluate drug substance supplier's technical documents and provide recommendations in API vendor selection
• Perform other functions as required or assigned

Requirements

• 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: 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.