Sterile Process Development Lead

Bryllan LLC; Brighton (MI); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Paid Time Off

Job summary

Biovire is seeking a Manager, Process Development in Brighton, Michigan. This leadership role drives technical transfer for sterile injectable products, partnering with Manufacturing, Quality, Validation, and Engineering to ensure robust, scalable processes and successful commercialization.

The role leads Process Engineers, supports new product introductions, and champions continuous improvement across the Brighton facility while upholding safety and quality standards.

Qualifications

• Experience leading process development and technical transfer for sterile injectable products.
• Strong knowledge of cGMP requirements and regulatory expectations.
• Experience developing manufacturing documentation (MBRs, SOPs, validation docs).

Responsibilities

• Lead technical transfer activities from development to commercial manufacturing.
• Manage and develop a team of Process Engineers; foster a high-performing culture.
• Collaborate with Manufacturing, Quality, Validation, Engineering, and Supply Chain.
• Drive process optimization and continuous improvement across operations.
• Ensure compliance with cGMP and regulatory requirements; maintain documentation.

Skills

Leadership

Process development

Technical transfer

cGMP knowledge

Cross-functional collaboration

Quality systems

Education

Bachelor's degree in Biology, Chemistry, Chemical Engineering, Biomedical Engineering

Graduate degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering

Job description

Biovire is seeking a Manager, Process Development in Brighton, Michigan. This leadership role drives technical transfer for sterile injectable products, partnering with Manufacturing, Quality, Validation, and Engineering to ensure robust, scalable processes and successful commercialization.

The role leads Process Engineers, supports new product introductions, and champions continuous improvement across the Brighton facility while upholding safety and quality standards.