Sterile Process Development Manager – Tech Transfer

Biovire, Inc.; Brighton Charter Township (MI); On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Medical, dental, vision, and life保险

Paid Time Off

Opportunity to build and grow a team

Job summary

Biovire, Inc. in Brighton, Michigan is seeking a Manager, Process Development to lead technical transfer activities for sterile injectable products and medical devices, ensuring robust, scalable processes from development through commercialization.

You will manage a team of Process Engineers, partner with Manufacturing and Quality, and drive continuous improvement to achieve manufacturing readiness, on-time launches, and compliant, high-quality products.

Qualifications

• Bachelor's degree in biology, chemistry, chemical engineering, or related life science required.
• Graduate degree in chemistry, biochemistry, or related field preferred.
• Minimum 5 years of pharmaceutical industry experience.
• 2–5 years of leadership or people management experience preferred.
• Experience supporting process development, technical transfer, or pharmaceutical manufacturing operations.
• Strong understanding of cGMP requirements, pharma processes, and regulatory expectations.
• Experience developing or maintaining MBRS, SOPs, validation docs and transfer packages.
• Excellent organizational, communication, writing, and cross-functional collaboration skills.
• Proven ability to lead teams, prioritize multiple projects, and drive continuous improvement.
• Commitment to safety, quality, integrity, and operational excellence.

Responsibilities

• Lead technical transfer activities for sterile injectable products and medical devices from development through commercial manufacturing.
• Manage and develop a team of Process Engineers while fostering a collaborative, high-performing culture.
• Partner with Manufacturing to support production schedules and successful product transfers.
• Drive process optimization, continuous improvement, and implementation of best practices.
• Ensure cGMP compliance, company policies, quality standards, and regulatory requirements.
• Develop, review, and maintain Master Batch Records, SOPs, validation master plans, cleaning validation docs, and transfer documentation.
• Identify opportunities to improve product quality, efficiency, and operational reliability.
• Collaborate cross-functionally to support launches, readiness, and commercialization.
• Support investigations, technical problem solving, and corrective actions as appropriate.
• Lead training, coaching, and development of Process Engineers.

Skills

Leadership

Technical transfer

Process development

cGMP knowledge

Cross-functional collaboration

Documentation/compliance

Project management

Team development

Education

Bachelor's degree in Biology, Chemistry, Chemical Engineering

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

Job description

Biovire, Inc. in Brighton, Michigan is seeking a Manager, Process Development to lead technical transfer activities for sterile injectable products and medical devices, ensuring robust, scalable processes from development through commercialization.

You will manage a team of Process Engineers, partner with Manufacturing and Quality, and drive continuous improvement to achieve manufacturing readiness, on-time launches, and compliant, high-quality products.