Endo
We want the best and brightest people to help us achieve our mission to develop and deliver life-enhancing products through focused execution. 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.
MUST HAVE EXPERIENCE WITH STERILITY TESTING** 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. 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. The Scientist also provides mentoring to Microbiologists.
Scope of Authority - span of control (work unit, site, department, division, etc.), Typically supports one Par business, at a single site
Analysis & Testing Validates analytical methods for Finished Product and Raw Material release and stability testing 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 Lab Equipment 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 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 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 Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs Takes active role in auditing laboratory logbooks/documentation to ensure compliance Minimal acceptable level of education, work experience and certifications required for the job 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
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. 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. Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office Suite Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc. 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 Ability to coach less senior staff and develop laboratory skills and ability Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. 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 Ability to wear personal protective equipment, including respirators, gloves, etc. 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.
MUST HAVE EXPERIENCE WITH STERILITY TESTING** 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. 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. The Scientist also provides mentoring to Microbiologists.
Scope of Authority - span of control (work unit, site, department, division, etc.), Typically supports one Par business, at a single site
Analysis & Testing Validates analytical methods for Finished Product and Raw Material release and stability testing 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 Lab Equipment 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 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 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 Performs work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting. Documents data generated in notebooks/worksheets/LIMS in compliance with SOPs Takes active role in auditing laboratory logbooks/documentation to ensure compliance Minimal acceptable level of education, work experience and certifications required for the job 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
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc. 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. Has demonstrated competence in conducting chemical analyses Strong knowledge of wet chemistry techniques Competency in Microsoft Office Suite Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
etc. 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 Ability to coach less senior staff and develop laboratory skills and ability Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc. 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 Ability to wear personal protective equipment, including respirators, gloves, etc. 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.