JOB SUMMARY:

The Quality Control Chemist performs analytical testing on raw materials, intermediates, and finished peptide products using a range of laboratory instruments to ensure compliance with quality standards and GMP guidelines. This role prepares samples, calibrates equipment, documents results, and identifies potential quality issues, supporting the development of corrective actions as needed. The chemist also contributes to SOP development and maintains a clean, compliant laboratory environment. This role contributes directly to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

EDUCATION & EXPERIENCE

• Required Education:
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• BS degree in Chemistry or Biochemistry or equivalent

• Experience:
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• 1+ years experience in a cGMP pharmaceutical/biotechnology laboratory

Skills & Competencies

• Technical Skills:

• • Proficient use of analytical techniques/instruments such as:
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• HPLC/UPLC - Analytical, GC, MS, pH Meter, Balance, Hand Tools, FTIR, Polarimeter, LC/MS, Elemental (Nitrogen) Analyzer, Karl-Fischer Titrator

• Proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, Teams, etc.)
• Soft Skills:
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• Ability to rapidly change focus during times of shifting or changing priorities

• Impeccable technical writing skills with extreme attention to detail, specifically the lexicology and grammatology of written English text as applied to technical writing
• Excellent organizational, multitasking, and communication skills
• o Ability to work as part of a team and also independently with minimal to no supervision
• Technical Proficiency in Analytical Testing
• cGMP Compliance & Documentation Accuracy
• Problem Solving & Quality Issue Resolution
• Attention to Detail & Data Integrity
• Collaboration & Communication

• Uses basic to moderately complex applicable test and measurement equipment and instruments to complete quality control tasks to ensure acceptability of raw materials, intermediate, in-process and finished products.
• Calibrates test and measurement equipment and devices to ensure accuracy in their use.
• Prepares samples and solutions for tests in strict accordance with established methodologies and protocols.
• Identifies material, product and/or methodology issues impacting acceptance and/or quality and reports same to appropriate senior QC personnel and/or management as directed.
• Documents all tests and measurements according to GMP guidelines.
• Assists and supports the development of corrective measures and/or actions to correct quality issues or problems.
• May perform basic troubleshooting of tests and measurement equipment.
• Is responsible for maintaining high housekeeping and cleanliness standards.
• May support the development of standard operating procedures (SOP’s) and certain protocols for the proper testing and measurement of materials and products.
• Performs and all additional duties as required for this position.