Job Title

Requisition

Location

Additional Locations

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 the development and validation of analytical methods. Specifically, this position provides non-routine testing, method development and method validation support using HPLC, UPLC, GC, GC-MS and LC-MS instrumentation, as well as additional wet chemistry and analytical chemistry techniques.

ESSENTIAL FUNCTIONS:

• 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. This includes Quality, Regulatory, and Manufacturing
• Write and peer review protocols and reports
• Interact with other LCM team members; may collaborate on joint projects - will interact, from time to time with manufacturing plant leaders/managers
• Support process/synthetic chemists
• Lead projects and operate with limited supervision
• Support Reference Standards program recertifying standards

MINIMUM REQUIREMENTS:

• Education/Experience:
  • 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/QUALIFICATIONS:

• Extensive hands-on experience with HPLC and GC method development is required; additional experience with Mass Spectrometry is strongly desired.
• Demonstrated complex chromatographic problem-solving skills are also required, as is a knowledge of cGMP, FDA, USP and ICH guidelines.
• 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
• Self-starter with strong work ethic, excellent written and verbal communication skills, the ability to successfully direct or manage various projects and to contribute / facilitate team investigations.
• Demonstrated ability to work well in a fast-paced team setting, especially in a resource limited environment.

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.