Sr. Scientist (Extractable & Leachable)

Responsible for technical evaluation of extractable and leachable studies to ensure that acceptable data is generated to support FDA drug applications. This role will provide technical training to other scientists and serve as a subject matter expert for mass spectrometry and extractable and leachable.

Responsibilities

• Reviews extractable/leachable study design concepts to meet regional requirements (i.e., USP and/or ISO 10993).
• Performs Extractable and Leachable testing in the lab, including method development, method validation, and stability testing in a cGMP environment.
• Acts as a subject matter expert in mass spectrometry and extractable/leachable.
• Operates and troubleshoots GC/MS, HR-LC/MS, and other analytical methods used for extractable and leachable testing in a cGMP environment.
• Evaluates analytical results and identifies trends/exceptions/interpretations relative to chemical characterization, product requirements, and toxicological assessment.
• Drafts, reviews, and approves E&L analytical testing protocols and reports.
• Performs mass spectral interpretation and unknown compound identification.
• Prepares E&L studies and safety assessment summaries for regulatory dossiers.
• Understands and effectively communicates the strategic focus and plan to team members.
• Communicates clearly with manager, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles while seeking input from other team members.
• Manages multiple projects and new scientific initiatives simultaneously, independently, with others, and as part of a team.
• Executes all E&L projects with detail and discipline to achieve all project milestones on time.
• Leads E/L project activities with minimum guidance and supervision.
• Trains junior scientists and contributes to the company's business needs.
• Provides constructive feedback to E&L and analytical colleagues and motivates other team members as required.
• Writes, reviews, and approves analytical methods, validation protocols and reports, E&L testing reports, SOPs, technical memos, investigation reports, change control, and E&L parts of regulatory dossiers.
• Performs drug product testing for potent compounds, cytotoxic substances, and/or controlled substances while following all safety procedures, including engineering controls, administrative controls, and Standard Operating Procedures.

Requirements

• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of related experience or a master’s degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3+ years of related experience or a 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 is a plus.
• Hands-on experience in various mass spectrometric operations, troubleshooting, and reporting tools.
• Experience with 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.
• 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).
• Excellent written and verbal communication skills in English; must be able to independently understand policies, procedures, training materials, and workplace communications written in English.
• Flexible, adaptive, with a strong desire to work in a dynamic environment and respond to urgency.
• Self-motivated, empowered personality, result- and deadline-oriented.
• Strong organizational skills, attention to detail, interpersonal skills, and ability to manage competing priorities.

Pay

Salary Range: $90,000 - $100,000. Final pay determinations will depend on various factors, including experience level, education, knowledge, skills, and abilities.

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday, and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental, and vision coverage
• Life insurance
• Disability coverage
• Wellness program

Applicants must be authorized to work for ANY employer in the United States. Fresenius Kabi is unable to sponsor or take over sponsorship of an employment visa either now or in the future.