Scientist, Lab Services - Microbiology

We want the best and brightest people at Endo to help us achieve our mission to develop and deliver life-enhancing products through focused execution. Our nearly 3,000 global team members understand the important role we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward. Our shared values of Integrity & Quality, Innovation, Drive, Collaboration and Empathy guide our team and enable us to deliver upon our vision of helping everyone we serve live their best life.

The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency and takes lead role in conducting all types of physical & chemical analyses (including the most complex analyses) using all equipment.

This position will have a significant role supporting pending ANDA submissions, product launches, complex product investigations, product development, and method lifecycle activities to achieve company goals and initiatives, and is considered an SME for these areas. Write and review SOPs, test methods, validation protocols and validation reports. The Senior Scientist also provides mentoring to Scientists and Chemists.

The Scientist, Laboratory Technical Services is primarily responsible for supporting the analytical testing requirements of commercial/pre-commercial materials and products, including method development, validation and transfer, pre-commercial/commercial testing of materials and samples in a regulated laboratory environment. Has expert proficiency in conducting all types of physical and chemical analyses (including the most complex analyses) using all equipment. This position will have a significant role supporting pending ANDA submissions, product launches, and method lifecycle activities to achieve company goals and initiatives.

Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists.

Scope of Authority – span of control (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Typically supports one Par business, at a single site

Accountability & Responsibilities

• Analysis & Testing (65% of time)
  • Validates analytical methods for Finished Product and Raw Material release and stability testing
  • Evaluates, troubleshoots/improves existing analytical methods when necessary
  • Prepares method validation protocols, reports, and analytical test methods
  • Performs testing to support process and formulation development (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
  • Performs work to support project as assigned with little oversight
  • Presents analytical data to project team for review and discussion
  • Reviews and approves laboratory test data and documentation (e.g. notebooks, raw data and technical documentation, test method, validation protocol, or validation report) for completeness and compliance when necessary
  • Reviews and evaluates drug substance supplier’s technical documents to ensure internal test requirements are adequate
  • Uses laboratory software for analyses
  • Is alert to and detects abnormalities during performances of tests and reviews
• General laboratory support (20% of time)
  • Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, sample receiving, chemical inventory, document filing and housekeeping
  • Cleans lab working surfaces and dispose of any excess chemicals, solutions, solvents, etc. in the special waste containers for each class of waste chemicals
  • Troubleshoots instrumentation and performs subsequent analyses
• Investigations (10% of time)
  • Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of…