Associate Scientist

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.

Phase-Appropriate Method Development and Validation: Perform phase-appropriate 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 cross-functional 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 execution. Manage cross-functional 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 high-potent 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 Bachelor's 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, in-process samples, API's 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 cross-functional 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 execution. Managed cross-functional 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 high-potent 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: $81,806.00 to $108,000.00/year

JOB TIME: Full Time

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