Sr. Scientist

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 92,000 - 95,000; Full time

Benefits offered by this job

401(k) plan

Paid vacation

Health benefits (medical, dental, and

Vision coverage

Employee assistance program

Job summary

Fresenius Kabi USA in Melrose Park, IL is seeking a Senior Scientist, Analytical Development to lead method development, validation, and analytical testing. You will design extractable/leachable studies and apply MS techniques to solve complex challenges in a cGMP environment.

The role requires strong knowledge of analytical chemistry, mass spectrometry, regulatory expectations (FDA/ISO), and the ability to manage multiple projects while training junior scientists.

Qualifications

• Bachelor’s in Pharmaceutical Sciences, Chemistry, or Biological Sciences with 5+ years' related experience.
• Master’s in the same fields with 3+ years' related experience.
• PhD in Pharmaceutical Sciences, Chemistry or Biological Sciences preferred.
• Strong knowledge of Analytical Chemistry and mass spectrometers.

Responsibilities

• Design and review extractable/leachable study concepts to meet regulatory requirements.
• Lead method development, validation, and analytical testing.
• Interpret MS data and support impurity identification.
• Train junior scientists and manage multiple projects.

Skills

Analytical Chemistry

Mass Spectrometry

Regulatory Compliance

Method Development

Problem Solving

Scientific Writing

Team Training

Education

Bachelor’s degree in Pharmaceutical Sciences or Chemistry or Biological Sciences

Master’s degree in Pharmaceutical Sciences or Chemistry or Biological Sciences

PhD in Pharmaceutical Sciences or Chemistry or Biological Sciences

Tools

Agilent HS-GC/MS

GC-MS

LC-MS

ICP-MS

Job description

Job Summary

The Senior Scientist, Analytical Development conducts all aspects of Analytical Development including method
development, experimentation, and record keeping. The incumbent must be able to develop and implement methods that
meet project needs. The position is responsible for conducting analytical development studies with increasing complexity in nature and solving problems to ensure a robust method can be performed in the laboratory.
This position is located in our Innovation and Development Center in Melrose Park, IL.
Salary Range: $92,000-95,000
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.

Responsibilities

• Reviews extractable/leachable study design concepts to meet regional requirements (i.e., USP <1663> and <1664> or ISO 10993).


• Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5+ years of relatedexperience or a master’s degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 3+years ofrelated 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 isrequired.


• The ability to apply chemistry knowledge for problem-solving and innovative approaches in Methoddevelopment, 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/MSinstruments to aid in data interpretation of chemical characterization of E&L compounds and for methodqualification/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 disciplineand 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 asrequired.


• Candidate should be able to write, review, and approve analytical methods, validation protocols andreports, E&L testing reports, SOPs, technical memos, Investigation reports, change control, and E&L part of theregulatory 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 prioritiesare essential for success.


• Must be willing to perform drug product testing for potent compounds, cytotoxic substances, and/or controlledsubstances while following and observing all safety procedures in place, which include the use of engineeringcontrols, 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, andwellness 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.