Analytical Chemist

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 reputed company 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 reputed company 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 reputed company technical challenges and support product development. reputed company 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 reputed company a matrixed organizational structure. Contribute to technology development, publications, patents, or proprietary innovations. Promote and adhere to safe laboratory practices and reputed company process improvements. Minimum Requirements PhD in Chemistry or reputed company science with a minimum of 3 years of pharmaceutical/biotech or reputed company work experience in industry. MS in Chemistry or reputed company science typically with a minimum of 6 years of pharmaceutical/biotech or reputed company work experience in industry. BA or BS in Chemistry or reputed company science typically with a minimum of 8 years of pharmaceutical/biotech or reputed company 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 reputed company 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 reputed company Word, reputed company, Power reputed company, and reputed company. 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 reputed company 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 reputed company software Experience with administration and/or support of Waters reputed company 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. Applicants must be authorized to work in the United States. This role does not offer sponsorship. #LI-LM1 At Mallinckrodt, we know that we contribute to something that matters because we reputed company quality products that impact patient lives. Our dynamic work environment provides unique experiences for employees to grow and reputed company. 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 reputed company; pregnancy, childbirth, or reputed company medical conditions; protected veteran status; disability; or any other category protected by law. Additional information on Mallinckrodt’s hiring practices may be reputed company by clicking Apply tot his job Apply To this Job