Chemist II

Job Description

Job Summary :

• We are seeking a Chemist II with hands-on experience in analytical techniques including FTIR, ICP-MS, LC-UV/LC-MS, and GC-FID/MS.
• The candidate will perform qualitative and quantitative analyses on a variety of sample types to support new product development.
• Responsibilities also include assisting in method development, maintaining laboratory instrumentation, and ensuring compliance with laboratory protocols.
• The Chemist II will contribute to protocol and report writing, data interpretation, and general laboratory support activities.
• Subject Matter (Expertise): Wet chemistry, Instrumentation: GC-FID/MS, LC-UV/LC-MS, FTIR, ICP-MS.

Duties & Responsibilities:

• Analytical Testing & Method Development.
• Performs routine and non-routine qualitative and quantitative analyses of raw materials, in-process samples, and finished products using techniques such as FTIR, ICP-MS, LC-UV/LC-MS, GC-FID/MS, and others.
• Develops and improves analytical methods; validates methods in compliance with regulatory standards.
• Supports product development activities by executing analytical testing, compatibility studies, and development plans.
• Applies a strong understanding of underlying chemistry to method development, data interpretation, and troubleshooting analytical challenges.

Documentation & Compliance:

• Prepares and reviews technical documents including protocols, reports, and data sheets for analytical parameters.
• Conducts analytical work in compliance with cGMP, regulatory standards, and safe laboratory practices; documents any variances appropriately.
• Frequently applies regulatory standards to drug and device testing.

Required Technical Skills:

• Maintains a collaborative environment across cross-functional teams within the Drug Delivery Systems group.
• Contributes to multiple projects simultaneously, including the preparation of scientific presentations and research articles.
• Plays an integral role in the strategic and tactical operations of the analytical department.

Laboratory Operations & Problem Solving

• Independently investigates and resolves analytical issues and proposes preventive solutions.
• Prepares reagents and solutions, performs general lab duties including equipment maintenance, cleaning, sample/standards preparation, and housekeeping.
• Outlines and implements effective solutions for laboratory investigations and supports continuous improvement initiatives.

Required Education & Skills :

• Requires broad theoretical job knowledge typically obtained through advanced education.
• Requires a Baccalaureate degree in Science from a four-year college or university (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).
• 2+ years of related experience with a bachelor’s degree, 0+ years of experience with a master’s degree.
• Familiarity with ISO 10993 standards for biological evaluation of medical devices.
• Strong problem-solving skills with a practical, hands-on approach to troubleshooting laboratory issues.
• Proven ability to thrive in a collaborative, fast-paced research setting.
• Excellent time management and prioritization skills for handling multiple concurrent projects effectively.

Specialized Knowledge Required:

• Demonstrated experience in developing analytical methods and performing material or product characterization using a range of chemical analysis techniques in academic or industry settings.
• Proficient in applying advanced analytical instrumentation, including FTIR, LC-UV/LC-MS, GC-FID/MS, and ICP-MS.
• Strong background in analytical chemistry with hands-on laboratory experience.
• Skilled in interpreting complex analytical data and applying mathematical concepts relevant to quantitative and qualitative laboratory analyses.