E&L & Chemical Characterization Leader (Pharma)

Kindeva Drug Delivery; Woodbury (MN); On-site; USD 150,000 - 190,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Health Savings Accounts

401k Benefits

Job summary

Kindeva Drug Delivery seeks a senior Manager, Chemical Characterization, Extractables & Leachables to lead a multidisciplinary analytical organization supporting pharmaceutical, combination product, and medical device programs.

This role provides scientific, operational, and people leadership for teams responsible for chemical characterization, method development, E&L assessments, and component clearance activities across inhalation, transdermal, injectable, and drug-device portfolios.

Qualifications

• Bachelor's degree in Chemistry or related scientific discipline.
• 10+ years of analytical chemistry experience in regulated industries.
• 5+ years of leadership in scientific or laboratory teams.
• Expertise in extractables and leachables, chemical characterization, trace-level testing.
• Experience with GC-MS, LC-MS, HRMS and related techniques.
• Strong knowledge of cGMP and quality systems.

Responsibilities

• Lead analytical chemists and laboratory professionals supporting chemical characterization, E&L testing, trace impurity analysis, and component clearance programs.
• Provide coaching, mentoring, performance management, and career development for scientific staff.
• Establish priorities and allocate resources across multiple programs and compliance-driven work.
• Foster a culture of scientific excellence, collaboration, accountability, and continuous improvement.
• Develop departmental goals, metrics, and capacity plans aligned with organizational objectives.
• Provide technical oversight for E&L programs across product portfolios.
• Lead method development, validation, transfer, and lifecycle management.
• Oversee investigations and non-targeted analyses; support regulatory submissions.

Skills

Leadership

Analytical chemistry

Regulatory knowledge

Communication

Education

Bachelor's degree in Chemistry/Analytical Chemistry/Pharmaceutical Sciences/Chemical Engineering

Tools

GC-MS

GC-MS/MS

LC-MS

LC-MS/MS

HRMS

ICP-MS

Job description

Kindeva Drug Delivery seeks a senior Manager, Chemical Characterization, Extractables & Leachables to lead a multidisciplinary analytical organization supporting pharmaceutical, combination product, and medical device programs.

This role provides scientific, operational, and people leadership for teams responsible for chemical characterization, method development, E&L assessments, and component clearance activities across inhalation, transdermal, injectable, and drug-device portfolios.