Job description
Job Title
Principal Analytical Chemist
Requisition
JR000013133 Principal Analytical Chemist (Open)
Location
St. Louis, MO (Pharma) - USA032
Additional Locations
St. Louis, MO
Job Description
Job Description
To support the expansion of small molecule API R&D capabilities within Mallinckrodt’s Specialty Generics business, this position within the Lifecycle Management organization will be responsible for analytical support and guidance for both current and new processes. Specifically, this position provides non-routine testing, investigations, 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:
- Extensive knowledge of and experience with chromatographic techniques
- 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
- Familiarity with cGMP, FDA, USP, and ICH guidelines
- Demonstrated excellent verbal and written communication skills
Department Specific / Non-Essential Function:
- 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)
- Controlled substance handling
Minimum Requirements:
- Education/Experience:
- BS in Chemistry with at least 10 years of relevant API analytical method development experience.
- MS (thesis preferred) with at least 7 years of relevant API analytical method development experience.
- PhD in Chemistry with at least 5 years of relevant API analytical method development 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.
Skills/Competencies:
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. Must be able to lead projects and operate with limited supervision.
Relationship with Others:
Interaction with other LCM team members is common. May collaborate on joint projects. Will interact, from time to time with manufacturing plant leaders/managers.
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.
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