Sr Analytical Chemist

Job Title

Requisition

Location

Additional Locations

Job Description Summary

Job Description

SUMMARY OF POSITION:

To support the expansion of API Development & Support capabilities within Mallinckrodt's Specialty Generics business, this new position will be responsible for collecting particle size, optical microscopy, thermal analysis, NMR, powder X-ray diffraction, and wet chemistry data. This data will be used to support the development of new API processes, the development of tests and specifications for use in QC, certifying new reference standards, and the validation of these processes in the manufacturing environment.

ESSENTIAL FUNCTIONS:

• Collect particle size, optical microscopy, thermal, and XRD data supporting morphology studies
• Collect NMR data; execute wet chemistry testing
• Follow ICH guidelines as well as USP, EP, and others for wet chemistry methods
• Complete work to address deficiencies
• Support St. Louis Plant Quality, Regulatory, and Manufacturing
• Write and peer review protocols and reports
• Interact with other API team members; may collaborate on joint projects
• Support process development chemists and chromatographers

MINIMUM REQUIREMENTS:

Education:

• BS in Chemistry with at least 5 years of relevant API analytical experience.
• MS with at least 3 years of relevant API analytical experience.
• PhD in Chemistry

Preferred Skills/Qualifications:

• Knowledge and experience with particle size by laser diffraction analysis and thermal analysis techniques such as TGA and DSC.
• Experience developing and troubleshooting methods for wet chemistry techniques, such as titrations, optical rotation, turbidity, moisture analyzer, and Karl Fischer.
• Experience with troubleshooting analytical instrumentation and methods.
• 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:
  • 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
• Self-starter with strong work ethic, excellent written and verbal communication skills, the ability contribute to projects/team investigations.

RELATIONSHIPS WITH OTHERS:

This position will interact with other members of the API Development and Support team, as well as other functional groups, such as QC, Manufacturing, and Regulatory Affairs. This position does not have direct reports.

WORKING CONDITIONS:

Typical laboratory conditions. Employees are required to wear eye protection and lab coats while in the lab area. Occasional handling of potent compounds or hazardous chemicals may require the use of additional PPE. Drug Enforcement Administration (DEA) regulated workplace. 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.