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Analytical Scientist II
AVEVA DRUG DELIVERY SYSTEMS INC
🇺🇸 United States
On-site
4 weeks ago
- GMP
- Regulatory Compliance
4 weeks ago
Not enough detail in this posting to match
Job Summary:
Laboratory position which involves development and validation of analytical methodology in support of the research projects involving testing of pharmaceutical components and/or drug products. Under general supervision, the position may require proficiency in support formulation, development method improvement and validation, testing per compendial pharmacopeia, etc.
Job Responsibilities
- Proficiency in multiple instrumentation techniques such as HPLC, GC, UV-VIS, dissolution equipment, pH measurement, titration, etc.
- General knowledge of cGMP and FDA requirements.
- Perform stability testing for GMP and R&D finished products
- Conduct analytical testing of API, excipients and components following compedial and validated methods
- Perform analytical method validation and method transfer with a minimum supervision.
- Follow company’s SOPs, STPS and comply with safety regulations.
- Maintain detailed record of experiments in the laboratory notebook.
- Timely communicate to supervisor(s) the obtained data and any issues aroused during testing
- Ability to analyze and interpret the analytical data under minimum supervision.
- Interpret specifications, standard operating procedures, and standard testing procedures.
- Writes/reviews protocols, reports, SOPs and STPs applicable to analytical laboratory under the supervision.
- Works as a member of a team to achieve all outcomes
- Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.
- Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
- All other relevant duties as assigned
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Qualifications
Job Requirements
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- Education
- Bachelor’s degree (B.S.) in chemistry or related field
- Master’s degree (M.S.)
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- Knowledge, Skills and Abilities
- General statistical applications such as normal ant T-test distribution, regression analysis, determination of test reliability and validity, analysis of variance, correlation techniques
- Analytical chemistry and common instrumentation
- General understanding of HPLC, GC, Drug Release, UV, IR, Titration.
- Using common computer software and analytical applications programs.
- Writing and interaction in English
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- Experience
- At least two (2) to five (5) years experience in pharmaceutical laboratory (B.S)
- At least zero (0) to three (3) years experience (M.S.)
Analytical Scientist II · AVEVA DRUG DELIVERY SYSTEMS INC