Biological Development Manager

The Biological Development Manager is responsible for leading an R&D group that develops vaccine products and procedures for both internal projects.

Duties

• Master Seed/Cell production and submission for testing
• Development and production of experimental vaccines
• Development of robust vaccine antigen and downstream processing methods
• Scale up of vaccine production methods
• Successful transfer of production methods to Manufacturing
• Provide technical support to Manufacturing
• Early-stage assay development for new projects
• Prepare and support submissions to regulatory agencies
• Establish and maintain project and/or annual timelines and budgets
• Strategic decision making based on company goals and objectives
• Manage the day to day activities of the group
• Ensure the proper training and safety of the group
• Maintain the facilities and equipment in applicable R&D labs
• Maintain concurrent and accurate documentation of all lab activities
• Generate new SOPs when needed
• Write and/or review internal and external protocols and reports
• Monitor and evaluate completion of tasks and projects
• Train new and current employees as needed

Skills

• Strong leadership skills with a proven track record of leading teams in a high paced environment.
• Experience managing and training junior scientists
• Demonstrated ability to work effectively with colleagues across other non-R&D departments
• Excellent verbal and written communication skills with both internal and external clients
• Demonstrated proficiency for protocol and report generation
• Experience with the USDA CVB and thorough understanding of the requirements of working in a regulated industry
• Knowledge and ability to analyze complex data and make best decisions based on this analysis

Education

• Bachelor’s Degree in a relevant scientific field (Biology, Microbiology, Molecular Biology, Biochemistry, or related) with a minimum of 10 years of industry experience, of which at least 5 involved supervising direct reports.
• Master’s Degree in a relevant scientific field, with a minimum of 6 years of industry experience, of which at least 3 involved supervising direct reports.
• PhD in a relevant scientific field with a minimum of 4 years of industry experience, of which at least 2 involved supervising direct reports.
• Must have demonstrated experience managing both projects and people within the biologics industry