R&D Manager

Key Responsibilities

• Lead and manage an R&D team focused on vaccine development and biologics process development.
• Oversee the development and production of experimental vaccines from early-stage research through manufacturing transfer.
• Direct bacterial fermentation, downstream concentration and recovery processes, lyophilization process development, optimization, scale-up, and technology transfer activities.
• Manage Master Seed/Cell production and coordinate submissions for required testing.
• Develop robust vaccine antigen production and downstream processing methods.
• Provide technical support to Manufacturing during process implementation and troubleshooting.
• Lead early-stage assay development for new product initiatives.
• Prepare, review, and support submissions to regulatory agencies.
• Develop project plans, establish timelines and budgets, and monitor project progress.
• Make strategic scientific and operational decisions aligned with organizational objectives.
• Build and maintain collaborative relationships with external clients and cross-functional internal teams.
• Supervise the daily operations of the R&D group, including project assignments and resource allocation.
• Mentor, train, and develop scientists and laboratory personnel.
• Ensure laboratory safety, compliance, and proper training of team members.
• Maintain laboratory facilities, equipment, and documentation in accordance with regulatory requirements.
• Generate new Standard Operating Procedures (SOPs) as needed.
• Write, review, and approve internal and external protocols, technical reports, and scientific documentation.
• Monitor project deliverables and ensure timely completion of milestones.

Required Qualifications

• Education & Experience: Bachelor's degree in Biology, Microbiology, Molecular Biology, Biochemistry, or a related scientific discipline plus 10+ years of relevant industry experience, including 5+ years of direct supervisory experience; ORMaster's degree in a related scientific discipline plus 6+ years of relevant industry experience, including 3+ years of direct supervisory experience; ORPhD in a related scientific discipline plus 4+ years of relevant industry experience, including 2+ years of direct supervisory experience.
• Skills & Experience: Demonstrated experience managing scientific projects and personnel within the biologics industry.Strong leadership skills with a proven ability to lead high-performing teams in a fast-paced environment.Experience mentoring, training, and developing junior scientists.Thorough understanding of USDA Center for Veterinary Biologics (CVB) regulations and regulated industry requirements.Experience with vaccine development and biologics process development.Knowledge of bacterial fermentation, downstream processing, scale-up, technology transfer, and lyophilization.Strong analytical and problem-solving skills with the ability to interpret complex scientific data.Excellent written and verbal communication skills with internal stakeholders and external clients.Demonstrated proficiency in protocol development, technical report writing, and scientific documentation.Ability to collaborate effectively across R&D, Manufacturing, Quality, Regulatory, and other cross-functional departments.

Preferred Qualifications

• Experience supporting regulatory submissions for biologics products.
• Proven success transferring laboratory processes into commercial manufacturing.
• Experience managing multiple concurrent scientific projects and priorities.