QC Chemist I (Tues-Sat 8am-5pm)
- Compensation
- Not disclosed
- Location
- Not listed
- Work setup
- Not specified
- Seniority
- Not specified
- Employment
- Not specified
- Experience
- 4+ years
- Category
- Science
- Posted
Skills
Full description
Position Summary
The 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 Requirements
- Bachelor'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 Includes
- Experience 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 other business and organizational needs. The disclosed range estimate has not been adjusted for any applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case.
Through its Sharing Expertise® initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services
Salar Range- $70,000- $78,300/ Annually