Process Development Lead for Sterile Tech Transfer

Biovire, Inc.; Michigan; On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Paid time off

Life insurance

Job summary

Biovire, Inc. in Brighton, Michigan is seeking a Manager, Process Development to lead technical transfer and ensure scalable, compliant processes for sterile injectable products.

You will oversee a team of Process Engineers, drive process optimization, and partner with Manufacturing, Quality, Validation, Engineering, and Supply Chain to enable product launches and readiness.

This role emphasizes cGMP compliance, documentation, and continuous improvement in a high-visibility environment.

Qualifications

• Requires a Bachelor's degree in biology, chemistry, chemical engineering or related field.
• Graduate degree in a life science is preferred.

Responsibilities

• Lead technical transfer activities for sterile injectable products from development through commercial manufacturing.
• Manage and develop a team of Process Engineers and foster a high-performing culture.
• Partner with Manufacturing to support production schedules and product transfer execution.
• Drive process optimization and continuous improvement with manufacturing best practices.
• Ensure cGMP compliance and regulatory requirements across processes.
• Develop and maintain Master Batch Records, SOPs, validation plans, and transfer documentation.
• Identify opportunities to enhance product quality, efficiency, and reliability.
• Collaborate cross-functionally with Manufacturing, Quality, Validation, and Engineering teams.
• Support investigations and CAPA implementation as needed.
• Lead training and development of Process Engineers.
• Promote a safe working environment and commitment to quality.

Skills

Leadership

cGMP knowledge

Technical writing

Cross-functional collaboration

Process development

Technical transfer

Education

Bachelor's degree in Biology, Chemistry, Chemical Engineering, Biomedical Engineering, or related life science

Graduate degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering, or related life science

Job description

Biovire, Inc. in Brighton, Michigan is seeking a Manager, Process Development to lead technical transfer and ensure scalable, compliant processes for sterile injectable products.

You will oversee a team of Process Engineers, drive process optimization, and partner with Manufacturing, Quality, Validation, Engineering, and Supply Chain to enable product launches and readiness.

This role emphasizes cGMP compliance, documentation, and continuous improvement in a high-visibility environment.