Description:
Summary
A Sr. Scientist I will be a key technical resource responsible for independently developing methods, generating reliable and interpreting data, using analytical instrument 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 instrumenttroubleshooting.or designing experiments, writing method validation protocols, conducting method validation, and processing and interpreting the analytical data.
Essential Duties & Responsibilities
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Develop and validation analytical method for drug substances, drug products, and excipients
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Conduct routine and advanced analytical tests in accordance with SOPs and regulatory guidance.
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Write protocols, reports, methods, standard operation procedure, and submission documents.
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Provide analytical support for formulation and process development.
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Perform independent scheduling and coordination of activities
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Complies with all companypolicies and standards
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Analyze analytical data, identify trends and provide recommendation.
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Review laboratory notebooks, raw data and technical documentation (e.g. test method, validation protocol, or validation report) in support of regulatory filings
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Train and provide technical guidance to junior scientists.
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Conduct laboratory investigation and prepare laboratory investigation report.
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Proactively provide Lab management with suggestions on how to improve the methods, lab practice or lab system.
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Evaluate and improve existing test methods
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Proactively provide Lab management with suggestions on how to improve the methods, lab practice orlab system.ection.
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Review and evaluate drug substance supplier’s technical documents and provide recommendation in APIvendor selection.
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Performs other functions asrequired or assigned
Requirements:
PREREQUISITES:
Education:
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Minimum B.S. degree in Analytical Chemistry, Biophysical/biochemical sciences, pharmaceutical sciences with 8 years industry experience
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Or Master’s Degree in Biochemistry, Biotechnology, Biology with 5+ years’ experience in protein mass spectrometry
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Or Ph.D. in Biochemistry, Biotechnology, Biology with 3+ years of experience in protein mass spectrometry
Experience:
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A strong theoretical understanding and experience in protein chemistry and biochemistry.
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In-depth hands-on experience with operation of HPLC, GC, dissolution, plate-readers and UV techniques is required.
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An in-depth understanding of USP requirements, ICH guidelines and USP/EP pharmacopeia requirements
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Excellent communication and technical writing skills
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Experience in method development, as well as method qualification/verification/validation in a GLP/GMP environment
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Strong experience in analytical method development and validation
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Demonstrated skills as a team-player and team-management.
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Ability to plan, schedule and work independently in a fast pace environment. Self-motivation, adaptability, and a positive attitude.
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Working knowledge of applicable safety and standards guidelines, such as SOP, cGMP, GLP, DEA regulations and/or MSDS.
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Ability to work under pressure and meet deadlines
SPECIALIZED KNOWLEDGE AND SKILLS:
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Ability to multitask technical responsibilities in a fast-paced, dynamic environment is required
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Proficiency with the following software is required: Microsoft Word, Excel, PowerPoint, and Outlook.
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Experience with Mass Spectrophotometer is required.
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Experience with Empower HPLC software programs is required.
