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
- 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 companypolicies 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
- Proactively provide Lab management with suggestions on how to improve the methods, lab practice orlab system.ection.
- Review and evaluate drug substance supplier’s technical documents and provide recommendation in APIvendor selection.
- Performs other functions asrequired 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.
