Sr Scientist

301044 Fresenius Kabi USA, LLC; Massachusetts; On-site; USD 95,000 - 110,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation

Holiday and personal days

Health benefits (medical, dental, VSP)

Job summary

Fresenius Kabi USA, LLC is seeking a senior scientist to lead technical evaluation of extractable and leachable studies and provide training to other scientists. The role focuses on mass spectrometry expertise and regulatory support for FDA drug applications.

The position is based in Melrose Park, IL, with a salary range of $95,000-$110,000 and a target bonus of 6% of base pay. Strong analytical and cGMP experience required.

Qualifications

• In-depth knowledge of Analytical Chemistry or Pharmaceutical Science and various Mass spectrometers.
• Ability to apply chemistry knowledge for problem-solving in Method development and validation.
• Experience with extractable/leachable identification and regulatory dossiers is a plus.

Responsibilities

• Review study design concepts to meet regional requirements (USP 1663/1664 or ISO 10993).
• Perform E&L testing in the lab including method development, validation, and stability in a cGMP environment.
• Act as SME in mass spectrometry and extractable/leachable.
• Operate and troubleshoot GC/MS, HR-LC/MS, and other analytical methods in cGMP.
• Draft, review and approve E&L protocols and reports.

Skills

Mass spectrometry

E&L testing

Analytical chemistry

Regulatory understanding

Education

Bachelor’s degree in Pharmaceutical Sciences

Bachelor’s degree in Chemistry

Bachelor’s degree in Biological Sciences

Master’s degree in Pharmaceutical Sciences

Master’s degree in Chemistry

PhD in Pharmaceutical Sciences

Tools

Agilent HS-GC/MS

GC-MS

LC-MS

ICP/MS

Job description

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. This position is located in our Innovation and Development Center in Melrose Park, IL. Salary Range: $95,000-110,000 Position is eligible to participate in a bonus plan with a target of 6% of the base salary 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

1. Reviews extractable/leachable study design concepts to meet regional requirements (i.e., USP <1663> and <1664> or ISO 10993).
2. Performs Extractable and Leachable testing in the lab, which includes method development, Method validation, and stability testing in a cGMP environment.
3. Acts as a subject matter expert in mass spectrometry and extractable/leachable
4. Operates and troubleshoots the GC/MS, HR-LC/MS, and other analytical methods used for extractable and leachable Testing in a cGMP environment.
5. Evaluate analytical results and identify trends/exceptions/interpretations of results relative to chemical characterization, product requirements, and toxicological assessment.
6. Draft, review, and approve E&L analytical testing protocols and reports.
7. Performs mass spectral interpretation and unknown compound identification.
8. Prepares E&L studies and safety assessment summaries for regulatory dossiers.
9. Understand and effectively communicate the strategic focus and plan to team members.
10. 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.
11. Other duties as assigned.

Requirements

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

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. Fresenius Kabi is a global health care company that specializes in injectable medicines, biosimilars, and technologies for infusion, transfusion, and clinical nutrition. Our expansive portfolio of products and global network of science and manufacturing centers provide essential support for the care of critical and chronically ill patients. With more than 41,000 employees worldwide, our dedicated team is united by our shared purpose: to put lifesaving medicines and technologies in the hands of people then . We call this purpose caring ...