Sr. Scientist (Extractable & Leachable)

Job Summary

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

Salary Range: $90,000 - $100,000

• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.
• Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

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.

Responsibilities

The Scientist 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, which includes 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 the GC/MS, HR-LC/MS, and other analytical methods used for extractable and leachable Testing in a cGMP environment.

Evaluate analytical results and identify trends/exceptions/interpretations of results relative to chemical characterization, product requirements, and toxicological assessment.

Draft, review, and approve 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.

Understand and effectively communicate the strategic focus and plan to team members.

Communicates clearly with the manager, peers, cross-functional teammates, and non-technical audiences by openly sharing project status and hurdles while seeking input from other team members.

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 is required.

• In-depth knowledge of Analytical Chemistry or Pharmaceutical Science and various Mass spectrometers is required. The ability to apply chemistry knowledge for problem-solving and innovative approaches in Method development, Method Validation, and analytical testing is required.
• Prior knowledge and work experience in extractable, leachable, and impurity identification is a plus.
• Knowledge and Hands-on experience in various mass spectrometric operations, troubleshooting, and reporting tools are required. 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.

• 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 is preferable
• 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.
• 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. 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 are essential for success.
• 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.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.