The major responsibility of the Analytical Method Validation Scientist is to perform method validation and verification activities. Scientists will work in a detail-oriented, compliant manor within a fast-paced, moderately stressful environment, on multiple concurrent projects. Our Scientists are expected to adhere to tight deadlines with shifting priorities. Additionally, this individual must be able to perform all tasks associated with Chemist II with routinely demonstrated excellence. The Analytical Method Validation Scientist will report to Head of Quality Control Laboratory and efficiently conduct all duties and responsibilities assigned and/or delegated by the Head of Quality Control Laboratory or the Site Head of Quality.
- Daily set-up, operation, troubleshooting and maintenance of instrumentation such as HPLC, UPLC, UV, GC, KF, FTIR, and IC in accordance with SOPs
- Provides technical project leadership, participating in protocol development and execution for test method validation/verification and related activities
- Provide expert level troubleshooting of laboratory equipment methods and processes
- Reviews generated data in a timely manner and elevates any Non-Conformance, Out of Specification, or other Deviation to Laboratory Management promptly for further investigation.
- Writing, reviewing and executing of method validation protocol and reports
- Performs investigative testing or other functions to assist with laboratory investigations.
- Assists in execution of training and acts as a mentor to less-experienced analysts.
- Works in support of production and development projects and may require weekend, off-shift work, or overtime as necessary to complete high priority work assignments
- Ability to demonstrate technical expertise in QC functions and provide expert levels of technical troubleshooting to the QC team
- Interacts regularly with other departments including R&D, RA, and QA to ensure priorities are aligned and products are on track.
- Works on development products, methods and projects to support R&D initiatives
- Reviews procedures and completes/updates required documentation as appropriate as part of periodic review process
- Performs laboratory testing of raw materials, bulk formulations, in-process, finished product, stability samples and any other samples from plant operations that require chemical or physical analysis in accordance with company SOP's as well as cGMP's
- Manages projects to improve Laboratory compliance and efficiency.
Education and Experience:
- B.S. or higher in Science Field (Chemistry Degree Preferred)
- 10 + years of demonstrated excellence in the field of analytical chemistry.
- 5 + years of experience in method validation/ verification
- Expertise in instrumental laboratory analysis.
- Prior experience in a pharmaceutical (cGMAP) laboratories setting is required
- Prior Project management experience preferred
- Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
- Proficient in technical writing
- Strong organizational skills and the ability to multitask
- Demonstrated ability in working independently and as part of a team
- Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
- Excellent communication (oral and written) and interpersonal skills
- Must be able to communicate technical, scientific, and regulatory information, both written and verbally
- Proficient knowledge USP and ICH guidelines of method validation and verification