Sr Scientist

Job Summary

Required Qualifications

• •Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience
• •Master's degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3+ years of related experience
• •PhD in Pharmaceutical Sciences, Chemistry, Biological Sciences, Chemical/Biomedical Engineering with one to three years of related experience
• •In-depth knowledge of Analytical Chemistry or Pharmaceutical Science and various Mass spectrometers
• •Ability to apply chemistry knowledge for problem-solving and innovative approaches in Method development, Method Validation, and analytical testing
• •Prior knowledge and work experience in extractable, leachable, and impurity identification
• •Knowledge and Hands-on experience in various mass spectrometric operations, troubleshooting, and reporting tools
• •Knowledge and experience in mass spectral interpretation and unknown compound identification
• •Clear understanding of FDA and other regulatory expectations concerning extractable and leachable (e.g., relevant ISO, USP, EP, JP, 21 CFR sections, and industry standards)
• •Ability to manage multiple projects and new scientific initiatives simultaneously, independently, with others, and as part of a team
• •Expected to execute all E&L projects with detail and discipline and achieve all project milestones on time
• •Expected to lead E/L project activities with minimum guidance and supervision
• •Able to train junior scientists
• •Candidate should be able to write, review, and approve analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, Investigation reports, change control, and E&L part of the regulatory dossiers
• •Excellent written and verbal communication skills
• •Flexible, adaptive, strong desire to work in a dynamic environment, responsive to urgency
• •Self-motivated, empowered personality, result- and deadline-oriented
• •Strong organizational skills, attention to detail, interpersonal skills, and ability to manage competing priorities
• •Must be willing to perform drug product testing for potent compounds, cytotoxic substances, and/or controlled substances while following and observing all safety procedures in place, which include the use of engineering controls, administrative controls, Standard Operating Procedures
• •The Company's primary business language is English
• •The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment

Desired Qualifications

• •A candidate with experience in any one of Agilent's HS-GC/MS, GC-MS, LC/MS, and ICP/MS instruments to aid in data interpretation of chemical characterization of E&L compounds and for method qualification/validation under a cGMP environment is highly preferable
• •Prior knowledge and work experience in extractable, leachable, and impurity identification
• •Clear understanding of FDA and other regulatory expectations concerning extractable and leachable (e.g., relevant ISO, USP, EP, JP, 21 CFR sections, and industry standards is preferable)
• •Able to train junior scientists and strongly desire to learn and contribute to the company's business needs
• •Provided constructive feedback to E&L and analytical colleagues and motivated other team members as required