What are the responsibilities and job description for the Principal Analytical Chemist position at Mallinckrodt?
Job Title
Principal Analytical Chemist
Requisition
JR000014680 Principal Analytical Chemist (Open)
Location
St. Louis, MO
Additional Locations
Job Description Summary
Job Description
The Principal Analytical Chemist will be responsible for providing analytical chemistry support for late-stage development and lifecycle management programs within the Global Technical Operations organization. This includes providing analytical chemistry expertise for method development and product improvement initiatives. The Senior Analytical Chemist will be responsible for the development, validation and transfer of analytical methods to internal and external GMP laboratories, as well as isolation and characterization of trace level impurities in drug substances and drug products.
Essential Functions
- Work collaboratively in a cross-functional environment, partnering with teams from Process Chemistry, Formulation, Quality, Operations, and Regulatory to ensure timely project execution.
- Evaluate and define project activities, establish timelines, coordinate functional resources, and ensure adherence to schedules.
- Ensure data and documentation quality meets established standards, with a key focus on drafting regulatory CMC submission documents.
- Develop creative and collaborative solutions for complex problems, considering downstream impacts and leveraging critical thinking skills.
- Maintain detailed laboratory records, adhering to safety protocols, and preparing documentation to support regulatory filings.
- Provide tactical input to address analytical chemistry challenges within Global Technical Operations.
- Contributions to new technologies, publications, patents, and trade secrets are expected as part of this role.
Minimum Requirements
Education / Experience / Skills:
- PhD in Chemistry or related science with 6 years of pharmaceutical/biotech or related work experience in industry.
- MS in Chemistry or related science typically with 8 years of pharmaceutical/biotech or related work experience in industry.
- BA or BS in Chemistry or related science typically with 10 years of pharmaceutical/biotech or related work experience in industry.
Skills/Competencies:
- Proficient in ICH guidelines, pharmacopeial requirements (USP, EP, JP), and regulatory standards, with the ability to apply them effectively.
- Expertise in analytical chemistry, including advanced techniques such as HPLC, UPLC, LC-MS, GC, GC-MS, NMR, UV & IR spectroscopy, and trace impurity characterization.
- Extensive experience in method development, validation, and transfer in compliance with regulatory guidelines.
- Skilled in preparing CMC regulatory submission summaries and solving complex analytical chemistry challenges.
- Strong hands-on experience with small molecules, peptides, and biologic products, particularly in HPLC/UPLC and LC/MS.
- Excellent written and verbal communication, organizational, and problem-solving skills, with a self-motivated and team-oriented mindset.
- Proficient in Microsoft Office Suite (Word, Excel, PowerPoint, Visio, Project) and Adobe.
- Demonstrates high customer focus, interpersonal skills, and the ability to work with all organizational levels, including senior management.
Preferred Skills/Qualifications:
- Strong familiarity with pharmaceutical GMP and regulatory guidelines
- Practical experience in bioanalytical chemistry
- Experience with administration and/or support of Waters Empower
Organizational Relationship/Scope:
Position directly reports to the Sr. Manager, Analytical Chemistry.
Working Conditions:
This position is 100% onsite an requires frequent work in a research laboratory, both standing at a bench and sitting. It also requires reaching into flammable cabinets. This position involves frequent work in an office environment, using a computer to analyze data and write reports and documenting experiments in notebooks. Occasional travel may be required for engagement with external laboratories and collaborators.
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Job Type: Full-time
Pay: $134,000.00 - $165,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Schedule:
- 8 hour shift
Work Location: In person
Salary : $134,000 - $165,000
