Senior Manager, Analytical Development

Job Summary

This position is responsible for the management of the Analytical Development staff.  This individual will design and assess analytical method development strategies, and will manage all analytical method validation activities performed by the Analytical Development group.  This person will collaborate with the Program Management, Site Management, Quality Unit and Regulatory Affairs to implement compliant analytical methods for the company and meet company targets for product introductions, transfers, etc.  Other responsibilities include overseeing of non-commercial stability programs, transferring analytical methods from Development to Quality Control (QC) and the transfer of methods between various other testing sites and Pharmalucence.  This person will assure analytical project tasks are accomplished within defined timelines, budget and required safety/compliance standards.  This position work under minimal supervision and represent Analytical Development during program team meetings. 

Area Of Responsibility

• Responsible for managing the design and execution of method development and validation activities and the oversight of analytical technology transfer activities using Quality by Design (QbD) and Design of Experiments (DOE) concepts to meet project timelines while assuring compliance to all regulatory requirements
• Oversee the work and supervise personnel in the Analytical Development Group, providing technical support and guidance
• Review experimental design, development reports, experimental data, protocols and protocol reports
• Oversee non-commercial stability programs, ensuring GLP compliance for regulatory submission purposes
• Lead analytical investigations and product impact assessments
• Evaluate new analytical techniques and technologies
• Interface with Quality, Regulatory, and outside laboratories, providing support as required
• Mentor and develop Analytical Development personnel to assure appropriate human resources are in place to meet company plans
• Other duties as assigned

Work Conditions:

• Laboratory, fume hood, warehouse and office areas
• Exposure to noise, hazardous and non-hazardous chemicals, syringes, and toxic metals.
• Requires protective clothing in lab areas such as lab coat, safety glasses and gloves

Physical Requirements:

• Stand, walk, sit, use hands and  fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
• Close vision
• Operate computer / office machines
• Lift up to 10 lbs.

Travel Estimate

Up to 10%

Education and Job Qualification

• Master's Degree in related scientific major required; PhD Degree in related scientific major preferred
• Excellent communications and project management skills
• Excellent technical writing ability
• Ability to optimize the job satisfaction and performance of analytical scientists on an individual and group level
• Attention to detail
• Knowledge of regulatory compliance requirements related to method development/validation
• Solid knowledge of chemical and analytical principles and their practical applications

Experience

• Minimum 8 years related experience in a pharmaceutical environment with previous managerial experience
• Excellent track record for meeting objectives and deadlines
• Strong technical knowledge in analytical chemistry including direct method development and validation experience
• Previous experience applying QbD and DOE to analytical method development required
• Demonstrated ability to assess, manage and mentor individuals to maintain high levels of scientific competency and group performance