Analytical Method Establishment Scientist

Analytical Method Establishment Scientist

Overview:

A mid-sized pharmaceutical company is seeking a skilled Method Establishment Scientist to support the implementation and training of High Voltage Leak Detection (HVLD) instrumentation . This individual will be responsible for establishing methodologies, drafting technical documentation, and training laboratory personnel to ensure successful adoption of HVLD technology within the organization.

Key Responsibilities:

• Lead method establishment and execution of testing using HVLD instrumentation for container closure integrity testing (CCIT).
• Train and mentor laboratory staff and quality team members on the proper use, maintenance, and troubleshooting of HVLD equipment.
• Draft and revise SOPs, protocols, and reports related to HVLD operations and CCIT methodologies.
• Collaborate with Quality and Laboratory teams to ensure compliance with regulatory expectations and internal standards.
• Provide technical expertise in CCIT methods and support validation activities as required.
• Ensure documentation is complete, accurate, and audit-ready.

Qualifications:

• Strong background in Quality and Laboratory operations within the pharmaceutical or biotech industry.
• Hands-on experience with HVLD instrumentation and CCIT methods is required.
• Proven ability to draft SOPs, protocols, and technical reports.
• Experience training and mentoring technical staff.
• Strong understanding of cGMP and regulatory compliance requirements.
• Excellent communication and documentation skills.