Sr. Scientist (Extractable & Leachable)

Job Summary

Required Qualifications

• •Applicants must be authorized to work for ANY employer in the United States.
• •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
• •The 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)
• •Candidate should be able 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
• •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 successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position

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 is a plus
• •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
• •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 are essential for success