Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Scientist, Analytical Development
7555 Gateway Boulevard Newark, CA 94560 US
Posted: 02/07/2024
2024-02-07
2024-03-27
Employment Type:
Contract
Job Category: Scientific
Job Number: 599048
Is job remote?: No
Country: United States
Job Description
JOB SUMMARY:
We are seeking a(n) Associate Scientist, Senior Associate Scientist, or Scientist to contribute to our growing Analytical Development team. The incumbent will participate in a team responsible for all aspects of method development, optimization, qualification/validation, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for our projects.
This is an on-site, technical laboratory-based position that involves analytical testing of biologics. Occasional remote work may be approved on a case-by-case basis. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, Formulation Development, Research and Development, QC, and other technical groups by providing analytical testing support.
ESSENTIAL DUTIES and RESPONSIBILITIES: • Execute technical analytical methodologies to support development and qualification/validation of test methods.
• Assist in writing and reviewing of analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control where needed.
• Operate, maintain, and install sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development.
• Provide support for laboratory operations – inventory tracking, reagent/solution preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GxP guidelines where required.
• Occasional weekend work may be needed based on timelines.
 Skills:
QUALIFICATION REQUIREMENTS: • Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or ICP-MS), CE-SDS, icIEF.
• Experience following protocols and SOPs.
• Be able to fluently communicate across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
ADDITIONAL EXPERIENCE PREFERRED, NOT REQUIRED: • Previous metrology experience (basic maintenance/troubleshooting ability).
• Knowledge of compendial assays such as Moisture Content (Karl Fischer), pH, and Light Box (Appearance) is favorable but not required.
Education: • Associate Scientist: Bachelor of Science degree in biological sciences or related field with 2+ years of experience in the biotechnology or pharmaceutical industry; or Master of Science with 0 year of industry experience. **exceptional candidates/new grads will be considered without experience
• Senior Associate Scientist: Bachelor of Science degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 3+ years of industry experience.
• Scientist: Bachelor of Science degree in biological sciences or related field with 7+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 5+ years of industry experience; or PhD with 2+ years of industry experience.
Pay Rate Range:$30-55/hr. Title and pay will be based on our assessment of education, skills, and experience relevant to our needs for the role.
We are seeking a(n) Associate Scientist, Senior Associate Scientist, or Scientist to contribute to our growing Analytical Development team. The incumbent will participate in a team responsible for all aspects of method development, optimization, qualification/validation, and execution for the characterization of complex biologics. This position requires hands-on laboratory experience working with analytical techniques for testing of drug substance and drug product to provide phase appropriate analytical development in support of clinical programs to commercial registration and post approval improvements for our projects.
This is an on-site, technical laboratory-based position that involves analytical testing of biologics. Occasional remote work may be approved on a case-by-case basis. The ideal candidate will be expected to work collaboratively and cross-functionally with Process Development, Formulation Development, Research and Development, QC, and other technical groups by providing analytical testing support.
ESSENTIAL DUTIES and RESPONSIBILITIES: • Execute technical analytical methodologies to support development and qualification/validation of test methods.
• Assist in writing and reviewing of analytical methods, protocols, reports, and other technical documents, including instrument qualification and change control where needed.
• Operate, maintain, and install sophisticated analytical instrumentation and associated computer control systems.
• Be part of a team that establishes, maintains, and improves technical operations and project outcomes in the Analytical Development.
• Provide support for laboratory operations – inventory tracking, reagent/solution preparation, sample management, and documentation review.
• Execute analytical and biological methods ensuring compliance with applicable ICH guidelines and global regulations.
• Ensure adherence to GxP guidelines where required.
• Occasional weekend work may be needed based on timelines.
 Skills:
QUALIFICATION REQUIREMENTS: • Working knowledge and experience performing analytical assay techniques such as absorbance (UV) assays, SDS-PAGE, ELISA, liquid chromatography ((U)HPLC), mass spectrometry (LC-MS and/or ICP-MS), CE-SDS, icIEF.
• Experience following protocols and SOPs.
• Be able to fluently communicate across technical and operational activities and work collaboratively to ensure successful execution.
• Strong written and verbal communication skills.
• Working knowledge of statistics.
• Ability to work on multiple projects simultaneously, demonstrating organizational and problem-solving skills.
• Self-motivated, proactive and driven individual with an interest in experimental design and development.
ADDITIONAL EXPERIENCE PREFERRED, NOT REQUIRED: • Previous metrology experience (basic maintenance/troubleshooting ability).
• Knowledge of compendial assays such as Moisture Content (Karl Fischer), pH, and Light Box (Appearance) is favorable but not required.
Education: • Associate Scientist: Bachelor of Science degree in biological sciences or related field with 2+ years of experience in the biotechnology or pharmaceutical industry; or Master of Science with 0 year of industry experience. **exceptional candidates/new grads will be considered without experience
• Senior Associate Scientist: Bachelor of Science degree in biological sciences or related field with 5+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 3+ years of industry experience.
• Scientist: Bachelor of Science degree in biological sciences or related field with 7+ years of progressive experience in the biotechnology or pharmaceutical industry; or Master of Science with 5+ years of industry experience; or PhD with 2+ years of industry experience.
Pay Rate Range:$30-55/hr. Title and pay will be based on our assessment of education, skills, and experience relevant to our needs for the role.
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