GMP Associate Chemist -Reference Standards

Responsibilities

• Support the qualification and requalification of Reference Standards through analytical testing techniques such as Appearance testing, FTIR, NMR, Liquid Chromatography (LC/HPLC/UPLC), TGA, DSC, and Karl Fischer titration, including performing correction factor calculations.
• Ensure adherence to GMP regulations by completing required training, following Standard Operating Procedures (SOPs), and maintaining compliance-related documentation.
• Review and verify laboratory documentation, calculations, and test preparations before sample analysis to help prevent deviations and laboratory investigations.
• Perform data analysis and troubleshoot methods and instrumentation.
• Prepare data for presentations and assist in generating technical reports.
• Cook up and coordinate sample shipments and testing activities with external contract laboratories, and accurately document and upload analytical results into internal databases.
• Work closely with cross-functional teams and external vendors, contract laboratories, and partners to support operational goals.
• Initiate and perform investigations, as needed.
• Write protocols and technical reports and transfer methods internally and externally.
• Contribute to a safe, organized, and compliant laboratory environment by participating in routine housekeeping and weekly laboratory cleanup activities.

Qualifications

• Demonstrated success in executing small molecule analytical chemistry methods adhering to SOPs and GMP guidelines.
• At least 1 year of continuous experience in GMP/ GLP regulated environment.
• Previous experience conducting and analyzing data for analytical methods such as UPLC/HPLC, FTIR, NMR, Thermogravimetric DSC/TGA, and KF titrations.
• Understanding of experimentation and data analysis using Empower software (Version III).
• Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience.
• Excellent technical writing experience such as protocols, reports, and SOPs.
• Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment.
• Strong computer, scientific, and organizational skills.
• Demonstrated exceptional attention to detail and strong project management capabilities, effectively managing project resources, including materials, personnel, and timelines, while proactively identifying and escalating critical issues to project leadership and management.
• Ability to work independently and as part of a team with internal and external clients, self‑motivation, adaptability, and a positive attitude.
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies.

Benefits

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.
• Compensation Range: $60,000 - $70,000.