Job Title: Chemical Projects Analyst

Job Description

This role is crucial for evaluating customer materials, assessing risks, and determining necessary laboratory testing for products. The Chemical Projects Analyst will play a key role in managing project milestones for the Chemistry Laboratory, ensuring timely delivery and compliance with industry standards.

Responsibilities

• Assure that project milestones for the Chemistry Laboratory are met in a timely manner, including material setup, laboratory qualifications, and test plans.
• Establish, review, and approve documentation such as stability protocols, SOPs, laboratory qualification protocols, and raw data.
• Represent the Chemistry Department in customer projects.
• Conduct assessment, qualification, and introduction of new analytical methods and procedures.
• Set up new incoming materials efficiently.
• Collaborate with management to ensure continuous improvement of the GMP systems in the analytical chemistry laboratory.
• Complete and evaluate Laboratory Investigations.
• Review documentation and release incoming materials such as API, excipients, and processing auxiliaries.
• Conduct, document, and assess analytical testing of raw materials, utilities, and in-process, release, and stability testing of finished products per SOPs and cGMPs/GLPs.
• Collect samples of raw materials and utilities.
• Collaborate with vendors for the external qualification and maintenance of chemical analysis instrumentation, and conduct internal qualification and maintenance.
• Ensure compliance with safety, environmental protection, and cGMP regulations.
• Assist in the Chemical Laboratory as needed.

Essential Skills

• Experience with GMP, Chemistry, Project Management.
• Proficient in HPLC, Laboratory practices, Pharmaceutical procedures, and Analytical chemistry.
• Skilled in using pH Meter and pH Testing.
• Knowledge of GLP and project management.
• Ability to provide client support.

Additional Skills & Qualifications

• Bachelor’s or Master’s degree in a scientific subject.
• Good knowledge of Quality Management systems.
• Minimum of 3 years of work experience in a GMP Chemical Analysis laboratory in the pharmaceutical industry.
• Proficiency in MS Office.

Work Environment

This position offers a hybrid work environment with 60% onsite and 40% remote work. The shift is from 8:00 AM to 4:30 PM, with flexible hours based on client needs, both domestic and international. The role is within a German-owned company that promotes growth from within and provides excellent benefits.