• Analytical Chemist

    Mallinckrodt Pharmaceuticals (Hazelwood, MO)


    Job Title

     

    Analytical Chemist

     

    Requisition

     

    JR000015105 Analytical Chemist (Open)

     

    Location

     

    Hazelwood, MO

     

    Additional Locations

     

    St. Louis, MO

    Job Description Summary

    Job Description

    The Analytical Chemist will provide analytical chemistry support for late-stage development and lifecycle management programs within the Global Technical Operations organization. Responsibilities include analytical method development, validation, and transfer to internal and external GMP laboratories; isolation and characterization of trace-level impurities in drug substances and drug products; and bioanalytical studies to support understanding of drug product mechanisms of action. This role requires ensuring data quality and documentation compliance with established standards. The Analytical Chemist will collaborate in a cross-functional environment with teams in Process Chemistry, Formulation, Quality, Operations, and Regulatory to ensure timely execution of project deliverables.

    Essential Functions

    + Lead the development, validation, and transfer of analytical methods using techniques such as HPLC, GC, LC-MS/MS, HRMS, MALDI-TOF, ICP-MS, and others.

    + Characterize trace-level impurities in drug substances, products, and biomatrix samples, with a focus on peptides and proteins.

    + Apply advanced knowledge in analytical chemistry to solve complex technical challenges and support product development.

    + Perform extractables and leachable testing and support protein and peptide purification efforts.

    + Ensure compliance with ICH guidelines, pharmacopeial standards (USP, EP, JP), and applicable regulatory requirements.

    + Prepare documentation for regulatory submissions and maintain high-quality laboratory records.

    + Utilize Quality by Design (QbD) principles and method development tools in analytical workflows.

    + Collaborate effectively with cross-functional teams within a matrixed organizational structure.

    + Contribute to technology development, publications, patents, or proprietary innovations.

    + Promote and adhere to safe laboratory practices and continuous process improvements.

    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.

    + Extensive hands-on experience with HPLC/UPLC, LC/HRMS, and LC/MS/MS, and ICP-MS, including demonstrated expertise in method development and validation for small molecules, peptides, and biologic products.

    + Strong background in the characterization and quantification of drug substances and drug products using LC/MS techniques

    + Proven ability to solve complex analytical chemistry problems

    + Self-starter with strong work ethic, excellent written and verbal communication skills; the ability to successfully conduct or manage various projects in a timely manner.

    + Ability to work in a team environment and operate with limited supervision.

    + Proficiency in Microsoft Word, Excel, Power Point, and Adobe.

    + Demonstrates strong organizational and planning skills; excellent interpersonal skills with ability to work in a team environment.

    + Demonstrates capability and comfort in communicating and interfacing with all levels in the organization including management and senior management.

    + Demonstrates high level of customer focus.

    Preferred Skills:

    + Solid understanding of pharmaceutical GMP and regulatory guidelines

    + Practical experience in bioanalytical chemistry.

    + Familiarity with Agilent and Waters analytical instruments and related software

    + Experience with administration and/or support of Waters Empower

    + Experience with bioinformatics software

    Organizational Relationship/Scope:

    Position directly reports to the 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.

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    At Mallinckrodt, we know that we contribute to something that matters because we make quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and develop.

     

    Invest in your own career with Mallinckrodt and let’s do something dynamic together.

     

    Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.

     

    Additional information on Mallinckrodt’s hiring practices may be found by clicking (https://secure.compliance360.com/ext/ESLKi3LFkqY=)