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