Scientist Method Transfer at Rochester

In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

Performs method development and validation for analytical procedures. Executes method transfer protocols. Participates, examines and solves technical problems associated with the manufacture, handling and storage of products by using analytical instrumentation, and classical wet chemical tests. Identifies and implements improvements in analytical testing methods. Provides training of analytical methods and new technologies. Performs all activities under cGMP following company policies.

• Performs analytical method development and validation for drug substance, drug product or any relevant material per FDA, ICH, USP/NF and other applicable pharmacopoeias and/or guidelines.
• Applies fundamental knowledge of Analytical Chemistry and advanced technologies in analysis, interpretation and understanding of the test results, for both qualitative and quantitative analyses.

• Participates in the planning and execution of product, process, cleaning and instrument validation studies; new raw materials, new components, vendor qualification and technical transfers.
• Writes technical reports for new test method, method development, validation, and method transfer. Writes, edits and revises analytical procedures and SOPs.
• Provides expertise and assists in writing investigation reports for LIR, NOE, and CFI.

• Performs routine maintenance, calibration, and performance verification on applicable instruments. Participates in new instrument validation.

• Performs routine and non-routine testing, as required following cGMP guidelines and company policies and participates in overall cGMP compliance for the Analytical Technology Laboratory.
• Assists in training of laboratory staff.
• The employee may need to be trained in handling controlled substances.

Establishes and maintains effective cross functional relationships.

Bachelors Degree in Chemistry or related science field with at least 4 years of analytical chemical laboratory experience. Pharmaceutical laboratory experience in analytical methods development and validation area will be extremely helpful. Equivalent combination of education and experience or training is acceptable.

About JHP Pharmaceuticals, LLC:
acnielsen careers
Country: USA, State: Michigan, City: Rochester, Company: JHP Pharmaceuticals.