Sr Scientist, Lab Technical Services

Why Endo?

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.

Job Description Summary

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 and 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.

Job Description

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.

Key Accountabilities -

Analysis & Testing

• Develops, designs, and 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, analytical test methods, and analytical sections for regulatory submissions, as required
• Develops and validates experiments designed to provide support for process and formulation activities (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
• Independently performs scheduling and coordination of activities of assigned projects
• 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, in support of regulatory filings and commercial product maintenance
• Reviews and evaluates drug substance supplier’s technical documents and provides recommendations of API vendor selection
• Is alert to and detects abnormalities during performances of tests and reviews

65%

Lab Equipment

• Evaluates new technologies to improve efficiencies and to reduce cost of testing
• 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

20%

Investigations

• Elevates questionable sample results, OOS, and aberrant results immediately to supervisor and recommends a course of action related to LTS activities
• Leads the effort in root cause identification of complex laboratory investigations
• Writes, edits, and reviews SOPs and laboratory investigations

10%

Training

• Coaches and provides technical guidance to more junior Scientists in method development and validation as well as troubleshooting of methods and analytical techniques
• Continuously updates knowledge with respect to the latest technologies related to analytical science
• Maintains assigned training records current and in-compliance

• Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, and chemical theories, methodologies and procedures

5%

Compliance

• Identifies need for SOPs and writes or revises, as appropriate
• Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting.  Work in compliance with cGMP/cGLP