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Article originally published on GEN The biotechnology industry achieved many firsts this past year, from the first approved drug that can slow the rates of cognitive and functional decline in adults with Alzheimer’s disease, to the first CRISPR-based gene editing...

BioTechLogic now hiring – Process Validation!

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

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