Job Title

Sr Analytical Chemist

Requisition

JR000014170 Sr Analytical Chemist (Open)

Location

St. Louis, MO (Pharma) - USA032

Additional Locations

St. Louis, MO

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 methodsFollow ICH guidelines as well as USP, EP, and others for chromatographic and mass spectrometry methodsComplete work to address deficienciesSupport St. Louis plant. This includes Quality, Regulatory, and ManufacturingWrite and peer review protocols and reportsInteract with other LCM team members; may collaborate on joint projects - will interact, from time to time with manufacturing plant leaders/managersSupport process/synthetic chemistsLead projects and operate with limited supervisionSupport 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 transfersExperience with troubleshooting analytical instrumentation and methodsDemonstrated complex chromatographic problem solving skillsDemonstrated ability to work well in a fast-paced team setting, lead projects, define and meet project timelines and adapt to changing prioritiesDemonstrated excellent verbal and written communication skillsFamiliarity with the following preferred:Latest pharmaceutical process chemistry and technologiesFDA Q7A Good Manufacturing Practice Guidance for APIsRequirements of various pharmacopeias in addition to USP (EP, JP, etc.)Controlled substance handlingPotent compound handlingSelf-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.