Job Information
Mallinckrodt Pharmaceuticals Staff Analytical Chemist in St. Louis, Missouri
Job Title
Staff Analytical Chemist
Requisition
JR000013923 Staff 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 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 API 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
MINIMUM REQUIREMENTS:
Education/Experience:
BS in Chemistry with at least 8 years of relevant API analytical method development experience.
MS (thesis preferred) with at least 5 years of relevant API analytical method development experience.
PhD in Chemistry with at least 3 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.
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 development 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.
Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.