Provide ongoing direction and constructive feedback to lab staff based on changing project needs.
Act as a scientific liaison between facilities and departments, including serving on the Material Review Board.
Review analytical results and ensure accurate reporting of stability and finished product testing.
Maintain equipment calibration and ensure timely completion of maintenance tasks.
Write and update standard operating procedures to reflect current practices.
Ensure laboratory compliance with relevant regulations and standards.
Support training in procedures, cGMP, and safety for laboratory personnel.
Prepare for internal and external audits, including those by the FDA.
Manage the annual laboratory budget along with related administrative duties.
Benefits
Comprehensive health insurance plans.
Retirement savings options with company match.
Opportunities for ongoing professional development and training.
Generous paid time off and holiday schedule.
Employee assistance programs and wellness initiatives.
Full Job Description
PRIMARY DUTIES AND RESPONSIBILITIES:
Write method validation protocols/reports and perform method development/validation/ verification for API and finished drug products.
Familiar with analytical testing of raw materials, in-process samples, finished products and analytical laboratory instrumentation, such as HPLC, GC, CE, ICP, FTIR, TOC, dissolution apparatus, etc.
Supervise the daily activities of the QC laboratory by establishing testing priorities and schedules and assignments of staff based on company priorities and objectives.
Provide daily direction, guidance and feedback to staff based work priorities and schedules.
Serves as scientific liaison to other facilities and departments and scientific/quality control member of Material Review Board.
Assists with appropriate review of analytical results of completed raw material, stability samples, and finished product testing.
Reviews and approves laboratory investigations, corrective and preventive actions, change requests, and deviations as necessary.
Maintain equipment calibration schedule and ensure that all required calibrations and maintenance are completed in a timely fashion.
Author standard operating procedures and assist with revision process of current procedures.
Ensure laboratory compliance with applicable regulations.
Assist with procedural, cGMP, and safety training of laboratory staff.
Assist with preparations for internal and external (including FDA) laboratory audits and inspections.
Administers annual laboratory budget and other related duties as required.
REQUIRED SKILLS, ABILITIES, AND QUALIFICATIONS:
Bachelors or higher degree in Chemistry or related discipline.
8+ years experience in a QC or Analytical chemistry laboratory.
3+ years experience in GLP or GMP (preferred) environment.
Demonstrated ability to act in a Lead capacity and provide direction to others.
Strong communication with ability to build relationships at all levels of the organization.
Ability to organize, prioritize and effectively perform concurrent tasks with minimal supervision.
