Senior Manager, Process Development

Job Summary

This position is responsible for the management of the Process Development group.  This individual will design and assess process development strategies for formulation, filtration, filling, and lyophilization or terminal sterilization of injectable final vial products.   This person will collaborate with the Production and Engineering groups to determine processes are compatible with manufacturing facilities and equipment, and will work with the Quality Unit and Regulatory Affairs to ensure the processes are appropriately developed and validated for a cGMP environment.  Other responsibilities include transferring developed processes to production, supporting the transfer of manufacturing processes to and from various manufacturing sites, as well as overseeing final product and drug substance contract manufacturers.  This person will assure process development project tasks are accomplished within defined timelines, budget and required safety/compliance standards.  This individual will work under minimal supervision. 

Area Of Responsibility

• Manages the design and execution of process development (formulation, filtration, filling, lyophilization) and validation activities using Quality by Design (QbD) and Design of Experiments (DOE) concepts where appropriate
• Oversees process technology transfer activities to and from external facilities and between Development and production

• Manages Process Development staff and provides technical support and guidance to help maintain project timelines while assuring compliance to all regulatory requirements
• Reviews experimental design, development reports, experimental data, protocols and protocol reports
• Provides miscellaneous technical support to Production, Engineering and Quality groups by leading process investigations and product impact assessments
• Oversees final product and drug substance contract manufacturers
• Works with Production, Engineering and Quality groups to help with assessment and implementation of new process techniques and technologies
• 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.
• Controlled manufacturing areas
• Requires protective clothing in lab areas such as lab coat, safety glasses and gloves

Physical Requirements:

• Use of repetitive motion
• Stand, walk, sit, use hands and fingers to handle or feel, reach with hands and arms, talk, hear
• Close vision
• Laboratory equipment (pH Meter, Analytical balance, Compressed Gas Cylinders, etc.)
• Computer/office machines

Travel Estimate

Up to 10%

Education and Job Qualification

• Bachelor’s Degree in related scientific major with 10 years relevant experience; Master's Degree in related scientific major with 5 years relevant experience

• Working knowledge of current Good Manufacturing Practices (cGMPs) and regulatory requirements for product submissions

• Excellent communications and project management skills
• Excellent technical writing ability
• Ability to optimize the job satisfaction and performance of scientists on an individual and group level
• Attention to detail
• Knowledge of regulatory compliance requirements related to process development/validation
• Solid knowledge of chemical principles and their practical applications to process development

Experience

• Minimum 5-10 years related management experience with excellent track record for meeting objectives and deadlines with prior experience in a pharmaceutical environment
• Strong technical knowledge in process development including prior experience in formulation and lyophilization cycle development
• Demonstrated ability to assess, manage and mentor individuals to maintain high levels of scientific competency and group performance

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification.  It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).