Analytical Chemist

4 weeks ago


St Louis, Missouri, United States Mallinckrodt Pharmaceuticals Full time

Job Title: Sr Analytical Chemist

Job Summary:

We are seeking a highly skilled Sr Analytical Chemist to join our API Development and Support team. The successful candidate will be responsible for the development and validation of analytical methods, providing non-routine testing, method development, and method validation support using HPLC, UPLC, GC, GC-MS, and LC-MS instrumentation.

Key Responsibilities:

  • Develop and validate chromatographic and mass spectrometry methods
  • Follow ICH guidelines as well as USP, EP, and others for chromatographic and mass spectrometry methods
  • Complete work to address deficiencies
  • Support St. Louis plant, including Quality, Regulatory, and Manufacturing
  • Write and peer review protocols and reports
  • Interact with other LCM team members and collaborate on joint projects
  • Support process/synthetic chemists
  • Lead projects and operate with limited supervision
  • Support Reference Standards program recertifying standards

Requirements:

  • BS in Chemistry with at least 5 years of relevant API analytical method development experience
  • MS (thesis preferred) with at least 3 years of relevant API analytical method development experience
  • PhD in Chemistry with no experience

Preferred Skills:

  • Extensive hands-on experience with HPLC and GC method development
  • Additional experience with Mass Spectrometry
  • Demonstrated complex chromatographic problem-solving skills
  • Knowledge and experience with mass spectrometry
  • Experience with analytical method development, validation, and transfers
  • Experience with troubleshooting analytical instrumentation and methods
  • Demonstrated complex chromatographic problem-solving skills
  • Demonstrated ability to work well in a fast-paced team setting, lead projects, define and meet project timelines, and adapt to changing priorities
  • Demonstrated excellent verbal and written communication skills

Familiarity with the following preferred:

  • Latest pharmaceutical process chemistry and technologies
  • FDA Q7A Good Manufacturing Practice Guidance for APIs
  • Requirements of various pharmacopeias in addition to USP (EP, JP, etc.)
  • Controlled substance handling
  • Potent compound handling

Relationships with Others:

This position requires a high degree of interaction with other API Development & Support team members. Interaction with other members of the larger API Support team is common. Will interact with other functional groups such as QC, QA, Manufacturing, and Regulatory Affairs leaders/managers.

Working Conditions:

Typical laboratory conditions. Employees are required to wear eye protection and lab coats while in the lab area. The employee occasionally lifts and/or moves up to 25 lbs.

Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop. Invest in your own career with Mallinckrodt and let's do something dynamic together.

Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.



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