Overview

B. Braun Medical, Inc.Company: B. Braun US Device Manufacturing LLCJob Posting Location: Allentown, Pennsylvania, United StatesFunctional Area: QualityWorking Model: OnsiteDays of Work: Saturday, Friday, Thursday, Wednesday, TuesdayShift: 5X8Relocation Available: NoRequisition ID: 12923B. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit Position SummaryThe Chemist I is responsible for supporting analytical testing, method validation, method transfers, and drug stability programs within a regulated laboratory environment. This role performs chemical analysis of raw materials, in-process samples, finished products, and stability samples while ensuring compliance with FDA, GMP, ISO, and applicable regulatory requirements. The Senior Chemist serves as a technical resource for laboratory investigations, data interpretation, and continuous improvement initiatives, contributing to product quality, regulatory compliance, and operational excellence. This position works closely with Quality, R&D, Regulatory, and Manufacturing teams to support business objectives. In This Role, You Will Have the Chance To:Perform analytical testing of raw materials, in-process samples, finished products, and stability samples using approved methods and specifications.Lead and support drug stability studies, including protocol execution, data review, and report generation.Operate, maintain, and troubleshoot analytical instrumentation, including HPLC, GC, and other characterization equipment.Lead method transfer, verification, and validation activities, including protocol and final report preparation.Investigate Out-of-Specification (OOS) results, deviations, and laboratory non-conformances while supporting corrective and preventive actions.Collaborate with cross-functional teams to interpret analytical data and prepare technical reports.Provide technical guidance and support to junior scientists and laboratory personnel. Essential RequirementsBachelor's degree in Chemistry, Pharmaceutical Sciences, or a related scientific discipline required; Master's degree preferred.4+ years of analytical laboratory experience in pharmaceutical, medical device, biotechnology, or other regulated industries.Strong experience operating analytical instrumentation, including HPLC and GC.Experience with Empower chromatography software and data analysis.Experience with analytical method validation, method transfer, and assay and/or impurity testing.Working knowledge of FDA, USP, EP, ICH, ISO, and GMP requirements.Strong technical writing, problem-solving, and laboratory investigation skills. Preferred Experience IncludesExperience developing, implementing, or maintaining drug stability programs.Experience writing stability protocols, reports, and regulatory documentation.Experience supporting laboratory compliance and audit readiness activities.Applicable industry or professional certifications. The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions, including skill sets, experience and training, licensure and certifications, and