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 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 Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical & chemical analyses (including complex analyses) using all equipment. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Scope of Authority - span of control (work unit, site, department, division, etc.), Typically supports one Par business, at a single site
Analysis & Testing Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses Reviews and approves laboratory test data and documentation for completeness and compliance Is alert to and detects abnormalities during performances of tests and reviews. Performs lab methods transfer and participate in method validation/verification studies 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 Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Writes, edits and reviews SOPs and laboratory investigations Training 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 assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs 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 4+ years’ relevant analytical laboratory experience OR Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience
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, 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. 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.
The Chemist III, under minimal supervision, performs QC laboratory chemical analyses of raw materials, in-process materials, stability & finished products, and testing to support process validation. Has demonstrated competence in conducting all types of physical & chemical analyses (including complex analyses) using all equipment. Learns and stays current with regulatory guidances and compendia relevant to laboratories and pharmaceutical manufacturing. Participates in troubleshooting analyses and instrumentation. Scope of Authority - span of control (work unit, site, department, division, etc.), Typically supports one Par business, at a single site
Analysis & Testing Conducts laboratory analyses according to approved test methods: finished product testing, stability testing, raw material testing, cleaning verification testing and manufacturing in-process testing. HPLC, UV-Vis, FT-IR, GC and dissolution tester, melting point apparatus, viscometer, Karl Fischer titrator, pH meter, analytical balance, etc. Uses laboratory software for analyses Reviews and approves laboratory test data and documentation for completeness and compliance Is alert to and detects abnormalities during performances of tests and reviews. Performs lab methods transfer and participate in method validation/verification studies 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 Elevates questionable sample results, OOS, and aberrant results immediately to Supervisor and recommends a course of action Writes, edits and reviews SOPs and laboratory investigations Training 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 assigned work in a timely and safe manner conforming to regulatory, company and compendiaI requirements within pharmaceutical manufacturing setting Document accurately data generated in notebooks/worksheets/LIMS in compliance with SOPs 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 4+ years’ relevant analytical laboratory experience OR Master’s Degree in above disciplines with 2+ years’ relevant analytical lab experience
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, 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. 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.