Job Title Senior Analytical Chemist Requisition JR000014680 Senior Analytical Chemist (Open) Location St. Louis, MO Additional Locations Job Description Summary Job Description The Senior Analytical Chemist will be responsible for providing analytical chemistry support for late-stage development and lifecycle management programs within the Global Technical Operations organization. The Senior Analytical Chemist will provide expertise in method development and product improvement, focusing on developing, validating, and transferring analytical methods to internal and external GMP labs. Responsibilities include isolating and characterizing trace-level impurities in drug substances and products while ensuring data and documentation meet quality standards. This role also involves drafting regulatory CMC submission documents and collaborating cross-functionally with Process Chemistry, Formulation, Quality, Operations, and Regulatory teams to ensure timely project execution. Essential Functions + Lead and coordinate project activities, ensuring timelines and functional resources stay on schedule. + Serve as the technical lead for studies and projects, providing expertise in analytical methodologies. + Develop innovative solutions for complex problems, considering downstream impacts. + Provide hands-on guidance with analytical techniques such as HPLC, UPLC, LC-MS, GC, GC-MS, NMR, SEM, UV & IR spectroscopy. + Characterize trace-level impurities in drug substances and products. + Specialize in peptide and protein analysis, as well as bioanalytical method development. + Maintain accurate laboratory records and ensure compliance with safety protocols. + Prepare documentation to support regulatory filings and contribute to CMC regulatory submissions. + Solve analytical chemistry challenges within Global Technical Operations. + Collaborate cross-functionally in a matrix environment. + Contribute to new technologies, publications, patents, and trade secrets. + Apply ICH guidelines, pharmacopeia requirements (USP, EP, JP), and ISO 10993 biocompatibility guidance as needed. + Utilize CDFSS/DFSS (Operational Excellence) tools for process improvement. Minimum Requirements + PhD in Chemistry or related science with a minimum of 6 years of pharmaceutical/biotech or related work experience in industry. + MS in Chemistry or related science typically with a minimum of 9 years of pharmaceutical/biotech or related work experience in industry. + BA or BS in Chemistry or related science typically with a minimum of 10 years of pharmaceutical/biotech or related work experience in industry. + Advanced knowledge of analytical chemistry with expertise in various techniques, theory, application, and troubleshooting. + Extensive hands-on experience in method development for HPLC, UPLC, GC, mass spectrometry, and spectroscopy. + Proven ability to develop, validate, and transfer analytical methods per regulatory guidelines. + Expertise in method development/validation for small molecules, peptides, and biologics. + Strong experience in drug substance and product characterization using LC/MS. + Skilled in complex analytical problem-solving and bioanalytical method development for peptides and proteins. + Self-motivated with a strong work ethic, excellent communication skills, and the ability to manage multiple projects independently. + Team player with strong organizational, planning, and interpersonal skills. + Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Project, Visio) and Adobe. + Comfortable communicating across all levels of the organization, including senior management, with a high level of customer focus. Preferred Skills/Qualifications: + 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 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. #LI-LM1 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=)