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.

• 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

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

• 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

• 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.