Associate Scientist
Associate Scientist
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
$ 81806 - 108000
1 Vacancy
Job Description
Job Title:Associate Scientist
City:West Deptford
State: NJ
JOB DESCRIPTION:
- Method Development:Perform analytical method development utilizing instruments including LC GC LCMS and ICPMS for raw materials and intermediates in compliance with ICH standards and regulatory guidelines.
- Method Validation Verification and Transfer:Perform analytical method validations method verifications and method transfers utilizing LC GC LCMS ICPMS UV IR and KF instruments according to ICH and USP requirements while maintaining compliance with current regulatory trends.
- PhaseAppropriate Method Development and Validation:Perform phaseappropriate analytical method development and validation for Phase I Phase II and Phase III projects.
- Analytical Techniques and Instrumentation:Use HPLC GC LCMS ICPMS KF ROI UV and IR instruments with comprehensive knowledge in troubleshooting.
- Documentation and Reporting:Document and report preparation in compliance with GMP environments. Ensure adherence to regulatory guidelines and maintain accurate records for audits and inspections (FDA EMA and ICH regulations).
- Project Management and Coordination:Work closely with departments (Chemical Development QC Regulatory Affairs Production and QA) to ensure smooth crossfunctional collaboration drive projects forward to meet timelines and regulatory standards. Manage priorities troubleshoot challenges and facilitate effective communication between teams.
- Training and Compliance:Maintain proper personal training records and ensure compliance with all required SOPs and regulatory guidelines.
- Client and Team Interaction:Coordinate between departments to ensure smooth project . Manage crossfunctional teams address client needs and maintain strong communication to meet project timelines. Ensure project objectives align with regulatory and compliance standards.
- Handle and analyze controlled substances and highpotent compounds in compliance with regulatory and safety guidelines. Adhere to DEA regulations GMP standards and other regulatory requirements. Work properly in a controlled substance environment.
- Use Empower(Waters) and LIMS Master Control and Track Wise software.
EDUCATION AND EXPERIENCE REQUIREMENT: Requires a Bachelors degree in Pharmacy and 3 years of experience in job offered or 3 years of experience in the Related Occupation
RELATED OCCUPATION:
Scientist or any other job title performing the following job duties:
- Method Development:Perform analytical method development utilizing instruments including LC GC LCMS and ICPMS for raw materials inprocess samples APIs and Drug products in compliance with ICH standards and regulatory guidelines.
- Method Validation Verification and Transfer:Perform analytical method validations method verifications and method transfers utilizing LC GC LCMS ICPMS UV IR and KF instruments according to ICH and USP requirements while maintaining compliance with current regulatory trends.
- Analytical Techniques and Instrumentation:Use HPLC GC LCMS ICPMS KF ROI UV and IR instruments with comprehensive knowledge in troubleshooting.
- Documentation and Reporting:Document and report preparation in compliance with GMP environments. Ensure adherence to regulatory guidelines and maintain accurate records for audits and inspections (FDA EMA and ICH regulations).
- Project Management and Coordination:Work closely with departments (Chemical Development QC Regulatory Affairs Production and QA) to ensure smooth crossfunctional collaboration drive projects forward to meet timelines and regulatory standards. Manage priorities troubleshoot challenges and facilitate effective communication between teams.
- Training and Compliance:Maintain proper personal training records and ensure compliance with all required SOPs and regulatory guidelines.
- Coordinate between departments to ensure smooth project . Managed crossfunctional teams address FDA queries and maintain strong communication to meet project timelines. Ensure project objectives align with regulatory and compliance standards.
- Handle and analyze controlled substances and highpotent compounds in compliance with regulatory and safety guidelines. Adhere to DEA regulations GMP standards and other regulatory requirements. Work properly in a controlled substance environment.
- Use Empower(Waters) LIMS and PRAGMA software.
SALARY RANGE: $81806.00 to $108000.00/year
JOB TIME: Full Time
#LIDNI
Required Experience:
IC
Employment Type
Full-Time
