BioTechLogic is accepting applications for a Manager of Technical Operations. Join our dynamic consulting team and work with clients around the world, helping them bring biopharmaceutical projects to market.
JOB DESCRIPTION
Title:
Manager, Technical Operations
Essential functions:
• Manage project activities within the BioTechLogic Technical Operations group enabling fulfillment of client contracts
• Manage the validation of biotechnology processes within the Technical Operations group
• Develop and review validation plans, including specific process development and validation strategies
• Ensure development and validation documentation is suitable for regulatory submission
• Establish personal development plans for the Technical Operations group, contributing to the continuous improvement of knowledge and experience within the company
• Effective tracking and communication of project progress and status to team members and clients, via e-mail and teleconference
• Lead meetings via teleconference or face-to-face
• Provide detailed input to clients, enabling informed decisions on process development and/or process validation strategies
• Provide on-site support at physical meetings, including those at contract manufacturers for information gathering or in support of manufacturing operations
• Support BioTechLogic’s marketing efforts by actively seeking new clients and repeat business opportunities
• Author or co-author articles for industry-related publications
JOB REQUIREMENTS
Competencies:
• Experience developing overall strategies and managing validation plans for biologic processes.
• Extensive experience and high skill level in the generation, review and execution of process validation and supporting validation protocols and reports at both laboratory and manufacturing scale
• Experience presenting validation plans, protocols and reports to regulatory agencies
• Aptitude for rapid understanding of biopharmaceutical manufacturing processes and demonstrated ability to furnish optimization and troubleshooting
• Expanded knowledge of cGMP systems such as documentation, change control and deviations coupled with a profound understanding of the work process for development, scale-up and technology transfer at contract manufacturing organizations (CMOs)
• Flexibility, motivation and a willingness to accept additional projects
• Ability to drive completion of multiple simultaneous projects among the Technical Operations group
• Ability and willingness to travel
Education/Experience:
• BS or MS in Chemical Engineering, Biology or related discipline, with 10+ years relevant experience
CONTACT: Peter Dellva, Head of Business and Finance
847-730-3475
pdellva@biotechlogic.com
www.biotechlogic.com
