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.
At Endo, we are building a diverse, equitable and inclusive workplace, and we are looking for talented individuals to join our team.
Job Description Summary
The Principal 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 representing Quality Control in cross-functional teams 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. The Principal Scientist is responsible for planning, designing, and execution of LTS activities, and also leading technical project teams of Scientists and Chemists.
Job Description
Responsibilities:
Analysis & Testing
- Leads the development and validation of analytical methods and the evaluation of compendial changes/updates
- Acts as a liaison between the Analytical R&D and Quality Control groups for transfer of knowledge and technology
- Develops and validates experiments designed to provide support for process and formulation activities (e.g. excipient compatibility, solubility, dissolution studies, stability/impurity assessment)
- Prepares method validation protocols, reports, analytical test methods, and analytical sections for regulatory submissions if required
- Evaluates, troubleshoots/improves existing analytical methods when necessary
- Independently performs scheduling and coordination of activities of assigned projects
- Oversees project status to ensure that project timelines are met and the team works in compliance with cGMP, GLPs and all other applicable requirements. Presents analytical data to project team for review and discussion
- Writes and reviews SOPs, test methods, validation protocols and validation reports
- 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
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
- Troubleshoots instrumentation and performs subsequent analyses
Investigations
- Investigates any out of specification or atypical results and prepares investigational reports
- Leads root cause identification of complex laboratory investigations, including identification and qualification of unknowns
- Evaluates questionable sample results, OOS, and aberrant results and recommends a course of action
- Writes, edits, and reviews SOPs and laboratory investigations
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
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. Works in compliance with cGMP/cGLP regulations
- Apprises management of the status of investigations and works with the Compliance group on determination of regulatory actions to be taken
- Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
- Follows internal processes related to controlled substances
Safety
- Follows EH&S procedures to ensure a safe work environment
- Follows all applicable safety and standards guidelines, such as SOPs, cGMP, DEA regulations good documentation practice and/or MSDS
Qualifications:
Education & Experience
- Bachelor of Science Degree in chemistry, chemical engineering or related field with 10 years’ relevant pharmaceutical laboratory experience OR
- Master’s Degree in above disciplines with 8 years’ relevant analytical lab experience OR
- PhD in above disciplines with 4 years’ relevant pharmaceutical lab experience
Knowledge
- Has strong knowledge of laboratory software and has expanded knowledge of chromatographic software (e.g. Waters Empower, Agilent ChemStation and Sotax WinSotax), using custom fields, custom calculations and custom reports
- Full proficiency with various laboratory techniques/instruments: HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc.
- Thorough knowledge of applicable safety and standards guidelines, such as FDA, ICH, SOP, cGMP, GLP, DEA regulations and/or MSDS
- Has demonstrated competence in conducting chemical analyses
- Strong knowledge of wet chemistry techniques
- Competency in Microsoft Office Suite
Skills & Abilities
- Ability to critically review, analyze data, interpret information, and draw conclusions from relevant or missing information
- Ability to display and analyze data in a logical manner
- Strong verbal and written communication skills as well as good computer skills
- Strong attention to details and accurate record keeping
- Establish and maintain cooperative working relationships with others.
- Solid organizational skills
- Ability to coach less senior staff and develop laboratory skills and ability
- Ability to take initiative, set priorities and follow through on assignments
Physical Requirements
- Extended periods of sitting, standing, walking, reaching, climbing/balancing, kneeling/crouching/crawling, looking at monitor for extended periods, moderate noise levels and potential business travel. Work is in an FDA and DEA-regulated pharma lab environment with risk of exposure to various chemicals
- Must occasionally lift and/or move up to 15-25 lbs.
- Ability to wear personal protective equipment, including respirators, gloves, etc.
- Specific visions abilities are required by this job include close vision and color vision
- Ability to occasionally tolerate significant differences in temperature and/or humidity for short periods
Commitment to Diversity, Equity, and Inclusion:
At Endo, our diversity unites and empowers us as One Team, and we are committed to cultivating, and valuing, each person’s unique perspective. We actively promote a culture of inclusion that draws strength from our broad spectrums of diversity, including race, ethnicity, religion, gender identity or expression, national origin, color, sexual orientation, disability status, age, and all our other unique characteristics, qualifications, demonstrated skills, achievements, and contributions, backgrounds, experiences, cultures, styles, and talents.
EEO Statement:
At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.
