Job Description

Job Summary: Our pharmaceutical client is seeking a highly skilled and experienced Senior Method Transfer and Validation Scientist to join our team. The successful candidate will have a strong background in analytical chemistry, specifically in method transfer and validation. This role will involve overseeing and coordinating the transfer of analytical methods from development to quality control laboratories and ensuring that these methods are accurately validated and compliant with regulatory requirements.

Key Responsibilities:

• Lead and manage the method transfer process, ensuring seamless transition of analytical methods from development to quality control.
• Oversee method validation activities, including the development and execution of validation protocols, analytical procedures, and reports.
• Ensure that all method transfer and validation activities are conducted in compliance with regulatory guidelines, such as ICH, FDA, and EMA.
• Collaborate with cross-functional teams, including R&D, quality control, manufacturing, and regulatory affairs, to facilitate method transfer and validation projects.
• Troubleshoot and resolve technical issues related to method transfer and validation.
• Provide technical expertise and guidance to junior scientists and laboratory staff.
• Maintain accurate and detailed documentation of all method transfer and validation activities.
• Stay current with industry trends and advancements in analytical chemistry and regulatory requirements.

Qualifications:

• Ph.D. or Master's degree in Analytical Chemistry, Chemistry, or a related field.
• Minimum of 5-7 years of experience in analytical chemistry, with a focus on method transfer and validation.
• Strong knowledge of regulatory requirements and guidelines related to method validation and transfer.
• Proven experience in developing and validating analytical methods for pharmaceutical products.
• Excellent problem-solving skills and ability to troubleshoot complex analytical issues.
• Strong leadership and project management skills.
• Experience with a variety of analytical techniques, such as HPLC, GC, LC-MS, and spectroscopy.
• Experience working in a cGMP environment.

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