One of the leading pharma companies of the country. Company offers competitive advantage stems from the world-class manufacturing facilities , advance R&D capabilities, extensive domestic network and a widespread global presence in over 40 countries. Multiple (5) Analytical Method Validation Scientist opportunities, AMV Scientist perform method validation and verification activities. Perform all tasks associated with Chemist II with routinely demonstrated excellence. The Analytical Method Validation Scientist will report to Head of Quality Control Laboratory/Sr. Director of Quality. With a significant presence in over 40 countries, A multi-billion dollar company leading the way across the globe within the Biotech and Pharmaceutical industry. Company is looking to continue expanding its US base further. HIRING multiple qualified Analytical Method Validation Scientist to join Quality Team in Levittown, PA.
These opportunities are CONTRACT/full-time (40 hours/week) contract opportunities based on W2/1099/Corp-to-Corp. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact us at [Click Here to Email Your Resumé] or and call Rose Chu, VP in Pharmaceutical & Biotech Services Group at #215-317-2999 for questions.
- 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.
- 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.
Required 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
- Proficient knowledge USP and ICH guidelines of method validation and verification
- Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
- Proficient in technical writing
Keywords: Senior Scientist, Analytical Method Validation Scientist, AMV Scientist, Analytical Scientist, set-up, operation, troubleshooting and maintenance of instrumentation, HPLC, UPLC, UV, GC, KF, FTIR, and IC, protocol development, execution, test method validation/verification, protocol development and execution for test method validation/verification, Non-Conformance, Out of Specification, Deviation to Laboratory Management, investigation. method validation protocol and reports, investigative testing or other functions to assist with laboratory investigations, QC functions, technical troubleshooting, development products, methods and projects to support R&D initiatives, laboratory testing of raw materials, bulk formulations, in-process, finished product, stability samples, plant operations, chemical or physical analysis, cGMP, Laboratory compliance, analytical chemistry, method validation/ verification, instrumental laboratory analysis, pharmaceutical (cGMAP) laboratories, Project management, USP and ICH guidelines, method validation and verification, technical writing, Quality Control Laboratory, Senior QC Scientist.
Please forward your credentials in Word format, in confidence, to: [Click Here to Email Your Resumé] Our pharmaceutical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.
Vice President of Pharma, CRO, Biotech and Medical Device Services
Connect with me: https://www.linkedin.com/in/rosechu/
Interested candidates please send resume in Word format Please reference job code 565889 when responding to this ad.