Endo
Scientist, Lab Tech Services - Microbiology
Why Us?
At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.
Job Description Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial 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 microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, 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 Scientist also provides mentoring to analysts.
Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial 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 microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists.
Support microbial testing for commercial and pre-commercial products
Support method development, validation, and transfer activities
Perform complex microbial analyses using lab equipment
Investigate complex product issues and support product development
Manage method lifecycle activities
Write and review SOPs, test methods, and validation documents
Serve as a subject matter expert (SME) in microbial testing
Mentor Scientists and Microbiologists
Key Responsibilities
Perform routine microbiological testing on raw materials, in-process samples, and finished products
Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests
Analyze environmental monitoring samples from cleanrooms and production areas
Support Validation of microbial methods for product and raw material testing
Prepare protocols, reports, and test methods
Conduct testing to support development and stability studies
Present and review data with project teams
Review lab documentation and supplier technical documents
Use lab software and detect abnormalities during testing
Provide general lab support and maintain equipment
Troubleshoot instruments and perform follow-up analyses
Report and investigate out-of-specification results
Write and review SOPs and investigation reports that support root cause analysis
Recommend corrective and preventive actions (CAPA)
Support training of microbiologists and improve training process records
Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
Ensure compliance with FDA and other regulatory standards
Follow safety procedures and handle hazardous materials properly
Uses laboratory software for analyses
Is alert to and detects abnormalities during performances of tests and reviews
65%
Lab Equipment
Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping
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
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
10%
Training
Trains microbiologists
Continuously updates knowledge with respect to the latest technologies related to Microbiology
Maintains assigned training records current and in-compliance
Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, 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. 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
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
continuous
Total
100%
Qualifications Education & Experience
Bachelor of Science Degree in Microbiology or related field with 6 years’ relevant microbiological laboratory experience OR
Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
PhD in above disciplines with some relevant laboratory experience preferred
Knowledge
Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc.
Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, 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 microbial testing
Strong knowledge of aseptic technique and contamination control
Competency in Microsoft Office Suite
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 and mentor junior staff while developing their laboratory skills and technical capabilities
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 vision 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 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 We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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Job Description Summary The Senior Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial 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 microbial analyses (including the most complex analyses) using all equipment. This position will have a role supporting pending ANDA submissions, product launches, complex investigations, onboarding of new equipment and technology, develops and executes training activities, 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 Scientist also provides mentoring to analysts.
Job Description The Scientist, Laboratory Technical Services is primarily responsible for supporting the microbial 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 microbial testing and analyses (including the most complex analyses). This position will have a significant role supporting improvements, training creation and executions, testing, and equipment onboarding. Write and review SOPs, test methods, validation protocols and reports. The Scientist also provides mentoring to Microbiologists.
Support microbial testing for commercial and pre-commercial products
Support method development, validation, and transfer activities
Perform complex microbial analyses using lab equipment
Investigate complex product issues and support product development
Manage method lifecycle activities
Write and review SOPs, test methods, and validation documents
Serve as a subject matter expert (SME) in microbial testing
Mentor Scientists and Microbiologists
Key Responsibilities
Perform routine microbiological testing on raw materials, in-process samples, and finished products
Conduct or understanding of sterility, endotoxin, bioburden, microbial limit, and microbial identification tests
Analyze environmental monitoring samples from cleanrooms and production areas
Support Validation of microbial methods for product and raw material testing
Prepare protocols, reports, and test methods
Conduct testing to support development and stability studies
Present and review data with project teams
Review lab documentation and supplier technical documents
Use lab software and detect abnormalities during testing
Provide general lab support and maintain equipment
Troubleshoot instruments and perform follow-up analyses
Report and investigate out-of-specification results
Write and review SOPs and investigation reports that support root cause analysis
Recommend corrective and preventive actions (CAPA)
Support training of microbiologists and improve training process records
Maintain accurate records in accordance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP)
Ensure compliance with FDA and other regulatory standards
Follow safety procedures and handle hazardous materials properly
Uses laboratory software for analyses
Is alert to and detects abnormalities during performances of tests and reviews
65%
Lab Equipment
Provides general laboratory support such as routine instrument cleaning/preventative maintenance/calibration, and housekeeping
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
Participates in root cause identification of complex laboratory investigations
Writes, edits, and reviews SOPs and laboratory investigations
10%
Training
Trains microbiologists
Continuously updates knowledge with respect to the latest technologies related to Microbiology
Maintains assigned training records current and in-compliance
Actively assumes/demonstrates responsibility in training others in good documentation practice, practical lab skills, 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. 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
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
continuous
Total
100%
Qualifications Education & Experience
Bachelor of Science Degree in Microbiology or related field with 6 years’ relevant microbiological laboratory experience OR
Master’s Degree in above disciplines with 4 years’ relevant analytical lab experience OR
PhD in above disciplines with some relevant laboratory experience preferred
Knowledge
Has expanded knowledge of Microbial Testing such as bacterial endotoxin, sterility, microbial and visual examination, microbial identification, etc.
Full proficiency with various laboratory techniques/instruments: microplate readers, isolator technology, microbial identification systems, 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 microbial testing
Strong knowledge of aseptic technique and contamination control
Competency in Microsoft Office Suite
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 and mentor junior staff while developing their laboratory skills and technical capabilities
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 vision 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 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 We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.
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