Job Title

Analytical Chemist

Requisition

JR000014681 Analytical Chemist (Open)

Location

St. Louis, MO

Additional Locations

Job Description Summary

Job Description

The 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 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. This individual will ensure that the quality of data and documentation conforms to established standards. Drafting of documents for regulatory CMC submissions will be a significant expectation for this role. The Analytical Chemist will collaborate closely in a cross-functional environment with colleagues from Process Chemistry, Formulation, Quality, Operations and Regulatory to ensure timely execution of deliverables. 

Essential Functions

Evaluate and define function activities for projects and determine appropriate timeline; coordinates activities with functional resources; keeps functional activities on schedule.

Develop alternatives and solutions for a range of complex problems. Solutions require creativity, critical thinking, and collaboration, considering a broad range of potential impacts, including those that are downstream.

Maintain detailed laboratory notebook records and demonstrate safe work habits within the laboratory.

Prepare documentation to support regulatory filings as required.

Provide tactical input for solving analytical chemistry challenges within Global Technical Operations.

Work collaboratively in a matrix environment with colleagues from other areas across the organization.

Provide significant contributions to new technologies, publications, patents, or trade secrets.

Minimum Requirements

PhD in Chemistry or related science with a minimum of 3 years of pharmaceutical/biotech or related work experience in industry.

MS in Chemistry or related science typically with a minimum of 6 years of pharmaceutical/biotech or related work experience in industry.

BA or BS in Chemistry or related science typically with a minimum of 8 years of pharmaceutical/biotech or related work experience in industry.

Possess advanced knowledge of analytical chemistry, including theory, application, and troubleshooting of various techniques.

Extensive hands-on experience with method development for HPLC, GC, mass spectrometry, and/or spectroscopy. Proficiency in developing, validating, and transferring analytical methods per current regulatory guidelines.

Strong knowledge and practical experience with analytical methodologies, including HPLC, UPLC, LC-MS, GC, GC-MS, NMR, SEM, UV & IR spectroscopy.

Prior experience in characterizing trace-level impurities in drug substances and drug products.

Familiarity with ICH guidelines and pharmacopeial standards (USP, EP, JP), applying them appropriately in laboratory activities. Experience in preparing CMC section summaries for regulatory submissions.

Understanding and application of CDFSS/DFSS (Operational Excellence) tools.

Strong verbal and written communication skills.

Self-starter with a strong work ethic and ability to manage multiple synthetic projects within deadlines.

Ability to work independently and collaboratively in a team environment.

Strong organizational, planning, and interpersonal skills.

Comfort in communicating across all organizational levels, including senior management.

Proficiency in Microsoft Word, Excel, PowerPoint, Visio, MS Project, and Adobe.

Demonstrates a high level of customer service and responsiveness.

Preferred Skills/Qualifications:

Extensive experience in the characterization of drug substances and drug products by LC/MS 

Demonstrated complex analytical chemistry problem solving skills are required.  

Strong familiarity with pharmaceutical GMP and regulatory guidelines  

Practical experience in the area of bioanalytical chemistry  

Experience with administration and/or support of Waters Empower

Experience with Agilent analytical instruments and associated software 

Organizational Relationship/Scope:
Position directly reports to the Sr. Manager, Analytical Chemistry.

Working Conditions:
This position requires frequent work in a research laboratory, both standing at a bench and seated. 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.