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Moses Edwards
Pharmaceutical Analyst
Summary
Highly accomplished Pharmaceutical Analyst with 10+ years of experience in analytical method development, validation, and quality assurance. Proven expertise in chromatographic techniques (HPLC, GC), mass spectrometry, and stability studies. Strong understanding of GLP and GMP regulations, and experience in regulatory submissions. Seeking a challenging role where I can contribute my technical skills and regulatory knowledge to ensure the safety and efficacy of pharmaceutical products.
Education
Bachelor’s in Pharmaceutical Sciences
October 2015
Skills
- Analytical Data Interpretation
- Chromatography (HPLC, GC)
- Drug Metabolism and Pharmacokinetics
- GLP and GMP Regulations
- Laboratory Information Management Systems (LIMS)
- Mass Spectrometry (MS)
Work Experience
Pharmaceutical Analyst
- Collaborated with scientists in preformulation and product development to optimize drug delivery systems and improve product stability.
- Prepared and submitted regulatory filings, including INDs and NDAs, to support the approval of new drug applications.
- Participated in quality audits and inspections conducted by regulatory agencies to ensure compliance with GMP regulations.
- Managed a team of laboratory technicians and provided technical guidance and training on analytical techniques and cGMP practices.
Pharmaceutical Analyst
- Developed and implemented analytical methods for the quantification of active pharmaceutical ingredients and impurities in drug products using HPLC, GC, and spectrophotometry.
- Conducted stability studies on drug products and raw materials to assess their longterm stability and identify any potential degradation products.
- Evaluated the quality of incoming raw materials and excipients by performing vendor audits and conducting analytical testing to ensure compliance with specifications.
- Troubleshooted and resolved manufacturing issues related to product quality failures, ensuring adherence to cGMP guidelines.
Accomplishments
- Successfully developed and implemented an automated analytical method for API testing, reducing analysis time by 40%
- Led a team of analysts to develop and validate a novel biomarker assay, enabling early detection of potential drug safety concerns
- Successfully implemented a quality management system for analytical laboratory, ensuring compliance with GLP and GMP standards
- Developed and patented a new analytical technique for the characterization of impurities in drug substances
- Successfully developed and validated a stabilityindicating assay for a new pharmaceutical product, ensuring its product quality and safety
Awards
- Top 10% Excellence Award for Outstanding Performance in Pharmaceutical Analysis
- Industry Recognition Award for Innovative Approach to Bioanalytical Method Development
- Pharmaceutical Analyst of the Year Award for Excellence in Regulatory Compliance and Data Integrity
- International Best Paper Award for Research in Analytical Chemistry for Development of a Novel HPLCMS/MS Method
Certificates
- Certified Pharmaceutical Analyst (CPA)
- Certified Quality Auditor (CQA)
- Good Clinical Practice (GCP)
- Good Laboratory Practice (GLP)
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How To Write Resume For Pharmaceutical Analyst
- Highlight your technical skills and experience in analytical method development and validation.
- Quantify your accomplishments using specific metrics and results whenever possible.
- Demonstrate your understanding of GLP and GMP regulations and how you have applied them in your work.
- Showcase your experience in regulatory submissions and your ability to communicate technical information to non-technical audiences.
- Emphasize your leadership and management skills if you have experience managing a team.
Essential Experience Highlights for a Strong Pharmaceutical Analyst Resume
- Developed and validated analytical methods for the quantification of active pharmaceutical ingredients (APIs) and impurities in drug products using HPLC, GC, and spectrophotometry.
- Conducted stability studies on drug products and raw materials to assess their long-term stability and identify potential degradation products.
- Evaluated the quality of incoming raw materials and excipients by performing vendor audits and conducting analytical testing to ensure compliance with specifications.
- Troubleshooted and resolved manufacturing issues related to product quality failures, ensuring adherence to cGMP guidelines.
- Collaborated with scientists in preformulation and product development to optimize drug delivery systems and improve product stability.
- Prepared and submitted regulatory filings, including INDs and NDAs, to support the approval of new drug applications.
- Managed a team of laboratory technicians and provided technical guidance and training on analytical techniques and cGMP practices.
Frequently Asked Questions (FAQ’s) For Pharmaceutical Analyst
What is the role of a Pharmaceutical Analyst?
A Pharmaceutical Analyst is responsible for ensuring the safety and efficacy of pharmaceutical products by conducting analytical tests on raw materials, drug products, and finished products. They develop and validate analytical methods, conduct stability studies, and troubleshoot manufacturing issues related to product quality.
What are the educational requirements for a Pharmaceutical Analyst?
A Pharmaceutical Analyst typically needs a bachelor’s degree in pharmaceutical sciences, chemistry, or a related field. Some employers may also require a master’s degree or a doctorate.
What are the key skills for a Pharmaceutical Analyst?
Key skills for a Pharmaceutical Analyst include analytical chemistry techniques (HPLC, GC, MS), knowledge of GLP and GMP regulations, and experience in regulatory submissions.
What is the job outlook for Pharmaceutical Analysts?
The job outlook for Pharmaceutical Analysts is expected to be good over the next few years due to the increasing demand for new and improved pharmaceutical products.
What are the salary expectations for Pharmaceutical Analysts?
Salary expectations for Pharmaceutical Analysts vary depending on experience, education, and location. According to Salary.com, the average salary for a Pharmaceutical Analyst in the United States is $75,000 per year.
What are the career advancement opportunities for Pharmaceutical Analysts?
Pharmaceutical Analysts can advance their careers by becoming supervisors, managers, or directors of quality control or research and development. They may also specialize in a particular area of pharmaceutical analysis, such as bioanalytical chemistry or drug metabolism.