Endo
Overview
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 & 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 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 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
Responsibilities 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 action related to LTS activities
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
Training (5% of time)
Trains junior Scientists/Chemists on 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 & Safety
Identifies need for SOPs and writes or revises, as appropriate
Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
Takes active role in auditing laboratory logbooks/documentation to ensure compliance
Follows internal processes related to controlled substances
Safety (as part of the same program)
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
Total 100%
Qualifications Education & Experience
Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR
Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
PhD in above disciplines with some relevant analytical laboratory experience preferred
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 and 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
Disclaimer Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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.
Job Details
Seniority level: Associate
Employment type: Full-time
Job function: Science
Industries: Pharmaceutical Manufacturing
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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 & 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 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 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
Responsibilities 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 action related to LTS activities
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
Training (5% of time)
Trains junior Scientists/Chemists on 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 & Safety
Identifies need for SOPs and writes or revises, as appropriate
Performs work in a timely and safe manner conforming to regulatory, company and compendial requirements within pharmaceutical manufacturing setting. Works in compliance with cGMP/cGLP regulations
Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs
Takes active role in auditing laboratory logbooks/documentation to ensure compliance
Follows internal processes related to controlled substances
Safety (as part of the same program)
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
Total 100%
Qualifications Education & Experience
Bachelor of Science Degree in chemistry, chemical engineering or related field with 6 years’ relevant analytical laboratory experience OR
Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
PhD in above disciplines with some relevant analytical laboratory experience preferred
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 and 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
Disclaimer Disclaimer:
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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.
Job Details
Seniority level: Associate
Employment type: Full-time
Job function: Science
Industries: Pharmaceutical Manufacturing
#J-18808-Ljbffr