Team Member Analytical Development Lab

Position Title:

Job Overview:

The Team Member - Analytical supports the transfer and validation of analytical methods from R&D or third-party laboratories to manufacturing or testing environments. This role ensures smooth method transfer, compliance with regulatory standards, and effective collaboration with cross-functional teams to maintain the accuracy and reliability of testing methods.

Key Responsibilities:

1. Method Transfer Support:

• Assist in transferring analytical methods from R&D or third-party laboratories and setting them up on new equipment.
• Ensure smooth implementation of methods at the receiving site.

2. Method Validation:

• Participate in the validation of analytical methods to ensure they meet standards for accuracy, precision, and reproducibility.
• Support the execution and documentation of validation studies.

3. Documentation:

• Maintain and review method transfer and validation documentation to ensure completeness and regulatory compliance.
• Ensure records are accurate and ready for audits or inspections.

4. Training:

• Support the training of laboratory staff on transferred methods, equipment usage, and best practices.

5. Troubleshooting:

• Assist in resolving issues related to method performance or equipment functionality during the transfer process.

6. Collaboration:

• Work closely with R&D, Quality Control (QC), Quality Assurance (QA), and Manufacturing teams to ensure seamless method transfer and address challenges effectively.

7. Compliance:

• Ensure all transferred and validated methods comply with regulatory standards such as GMP, ICH, and other relevant guidelines.

8. Reporting:

• Assist in preparing detailed reports on validation and transfer outcomes, including data analysis and findings.

Key Skills:

Technical Skills:

• Proficiency in analytical techniques such as HPLC, GC, spectroscopy, and related methods.
• Strong understanding of method validation principles and regulatory standards.
• Experience with troubleshooting analytical methods and equipment.

Soft Skills:

• Excellent attention to detail and organizational skills.
• Strong communication and teamwork abilities for effective collaboration with cross-functional teams.
• Analytical thinking and problem-solving skills to address method transfer challenges.

Qualifications & Experience:

• Education:

  Master’s degree in Chemistry, Analytical Chemistry, Pharmaceutical Sciences, or a related field.

• Experience:

• 4-7 years of experience in analytical chemistry, method development, validation, or related fields, preferably in pharmaceutical or biotech industries.