Job Summary:

The analytical method validation chemist is responsible for designing, planning and executing experiments to determine quality attributes of various samples. Analytical methods are validated to ensure compliance with regulatory standards. This role contributes to PolyPeptide’s commitment to delivering exceptional quality and on-time delivery to our customers.

Key Responsibilities:

1. Generate, review and execute phase appropriate method validation/verification/transfer protocols to meet project timelines and deliverables.
2. Execute feasibility (pre-validation) studies to support validation experimental design.
3. Write, review and assist in the evaluation of the effectiveness of SOPs and identify necessary changes following validation activities.
4. Work closely with Quality Assurance to ensure documents are reviewed and approved in a timely manner.
5. Troubleshoot equipment or analytical method issues to minimize downtime and optimize performance.
6. Assist with investigation into deviation related to validation studies, identify root causes, issue corrective and preventive actions.
7. Assist with training, competency assessment and performance evaluations of laboratory personnel as appropriate.

Qualifications:

Education & Experience

• Required Education: Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field
• Experience: Minimum 2 years in cGMP pharmaceutical manufacturing or a regulated environment; peptide manufacturing experience preferred.

Skills & Competencies

• Technical Skills: Strong technical knowledge of HPLC, GC and MS, proficient use of Microsoft Office suite of applications (Outlook, Excel, Word, PowerPoint, etc.)
• Soft Skills: Ability to work as part of a team and also independently with minimal to no supervision. Ability to rapidly change focus during times of shifting or changing priorities. Much collaborate across organization and functional boundaries. Excellent organizational, multitasking and communication skills.

Work Environment & Physical Demands:

• Physical Requirements: Ability to work in a laboratory setting, which may involve standing for extended periods. Capacity to lift or move light-to-moderate equipment or materials when necessary (in accordance with safety guidelines).
• Work Environment: Main work setting is in a laboratory environment requiring Personal Protective Equipment (PPE).

Performance Metrics (KPIs):

• On-Time Validation Deliverables:
• Complete validation projects within designated timelines, achieving a target of [e.g., 95%] completion.
• Compliance Rate:
• Maintain [e.g., 98%] adherence to cGMP standards, evidenced by minimal deviation or findings during internal and external audits.
• Documentation Accuracy:
• Achieve 100% accuracy in validation documentation with no major discrepancies identified during review or audits.

Salary: $58k-65k per year

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.