Planet Pharma
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https://www.propharmagroup.com
https://www.propharmagroup.com
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Target PR Range: 25-35/hr
*Depending on experience
Overview:
Join our Parenteral Product Development Science and Technology - Analytical Development group and contribute to exciting programs transitioning from the development stage to optimization and commercialization. As a member of the team, you will support the development, optimization, and validation of analytical methods by ensuring that they are well documented. You'll gain experience in documentation of product control strategies, analytical methods, and stability studies. This is not a laboratory position.
Key Responsibilities:
· Support Analytical Leads and Lab Managers by assisting with the creation and review of protocols, reports, specifications, and other technical documents. This may include facilitating communication between different laboratories, reviewing data, drafting sections and data tables, data verification, and other tasks as needed.
· Execute change management processes for document updates.
· Assist in compiling and verifying information for submissions and responding to health authority queries.
· Gain hands-on experience in regulatory compliance and analytical data.
Qualifications:
· Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) and 5+ years’ experience or Master’s Degree with 2+ years’ experience.
· Basic understanding of analytical methods, test method validation, and Good Documentation Practices.
· Good organizational skills and attention to detail.
· Ability to manage and prioritize multiple projects simultaneously and to work within timelines.
· Interest in learning and developing scientific writing skills.
· Interest in learning about international pharmaceutical guidelines and regulatory submission processes.
Preferred Qualifications:
· Practical experience in method validation of analytical or bioanalytical techniques (for example: HPLC, SEC, CEX, icIEF, CE-SDS, ELISA, etc.) is a plus.
Chemist II, Analytical Documentation
Posted: 03/20/2025
2025-03-20
2025-04-24
Employment Type:
Contract
Job Category: Scientific
Job Number: 618367
Is job remote?: No
Country: United States
Job Description
Target PR Range: 25-35/hr
*Depending on experience
Overview:
Join our Parenteral Product Development Science and Technology - Analytical Development group and contribute to exciting programs transitioning from the development stage to optimization and commercialization. As a member of the team, you will support the development, optimization, and validation of analytical methods by ensuring that they are well documented. You'll gain experience in documentation of product control strategies, analytical methods, and stability studies. This is not a laboratory position.
Key Responsibilities:
· Support Analytical Leads and Lab Managers by assisting with the creation and review of protocols, reports, specifications, and other technical documents. This may include facilitating communication between different laboratories, reviewing data, drafting sections and data tables, data verification, and other tasks as needed.
· Execute change management processes for document updates.
· Assist in compiling and verifying information for submissions and responding to health authority queries.
· Gain hands-on experience in regulatory compliance and analytical data.
Qualifications:
· Bachelor’s Degree in a scientific discipline (e.g., Analytical Chemistry, Biochemistry, or Biology) and 5+ years’ experience or Master’s Degree with 2+ years’ experience.
· Basic understanding of analytical methods, test method validation, and Good Documentation Practices.
· Good organizational skills and attention to detail.
· Ability to manage and prioritize multiple projects simultaneously and to work within timelines.
· Interest in learning and developing scientific writing skills.
· Interest in learning about international pharmaceutical guidelines and regulatory submission processes.
Preferred Qualifications:
· Practical experience in method validation of analytical or bioanalytical techniques (for example: HPLC, SEC, CEX, icIEF, CE-SDS, ELISA, etc.) is a plus.
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