Biological Development Manager

Huvepharma, Inc.; Lincoln (NE); On-site; USD 120,000 - 170,000; Full time

Job summary

Huvepharma, Inc. seeks a Biological Development Manager to lead an R&D group focused on vaccine development, process improvement and technology transfer. You will drive project timelines, budgets and cross‑functional collaboration with Manufacturing, QA and regulatory teams.

The role demands strong leadership, deep regulatory understanding for biologics, and excellence in documentation and data analysis to advance internal vaccine programs.

Qualifications

• Bachelor’s Degree in biology/microbiology/biochemistry with 10+ years industry experience and 5+ supervising
• Master’s Degree with 6+ years industry experience, 3+ supervising
• PhD with 4+ years industry experience, 2+ supervising
• Experience managing both projects and people within the biologics industry

Responsibilities

• Lead an R&D group developing vaccine products and procedures
• Scale up vaccine production methods
• Transfer production methods to Manufacturing
• Provide technical support to Manufacturing
• Prepare regulatory submissions to agencies
• Establish timelines and budgets for projects
• Train and supervise staff in the group
• Maintain facilities and equipment in R&D labs
• Maintain documentation and generate SOPs/reports
• Monitor progress and ensure task completion
• Make strategic decisions aligned with company goals

Skills

Leadership

Mentoring

Cross-functional collaboration

Communication

Documentation

Regulatory knowledge

Data analysis

Education

Bachelor’s Degree in biology/microbiology/biochemistry

Master’s Degree in a relevant field

PhD in a relevant field

Experience managing projects and people in biologics

Job description

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