Job Description

Job Title: Analytical Validation Chemist

Location: San Diego, CA

Employment Type: Initial Contract-to-Hire (6 months)

The position of Analytical Method Validation Chemist focuses on ensuring that analytical methods used in testing and manufacturing meet regulatory standards and are effective for the desired purposes. Here are the primary functions of this role:

Responsibilities :

1. Method Validation/Verification/Transfer: Generate, review, and execute protocols for validating and transferring analytical methods to ensure they meet project timelines and regulatory requirements.
2. Feasibility Studies: Conduct pre-validation studies to support experimental designs that validate methods.
3. SOP Review: Write, review, and assess Standard Operating Procedures (SOPs) to ensure they align with validation results and recommend necessary updates.
4. Collaboration with Quality Assurance: Work closely with Quality Assurance to ensure timely document review and approval.
5. Troubleshooting: Address and resolve issues related to equipment or methods to minimize downtime and ensure optimal performance.
6. Deviation Investigation: Assist in investigating any deviations in validation studies, determine root causes, and issue corrective and preventive actions.
7. Training and Performance Evaluation: Help train laboratory personnel, assess their competencies, and assist in performance evaluations.

Key requirements for this role include:

• A Bachelor’s degree in Chemistry, Biochemistry, Engineering, or a related field.
• A minimum of 2 years of experience in a cGMP pharmaceutical or regulated environment (preferably with peptide manufacturing experience).
• Strong knowledge of techniques like HPLC, GC, and MS.
• Proficiency with Microsoft Office tools.
• Excellent organizational, multitasking, and communication skills.

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