Process Development Manager

Manager, Process Development Engineering Organization

Brighton, Michigan

Biovire is advancing toward commercialization with a focus on innovation, operational excellence, and scalable GMP manufacturing. We are seeking a Manager, Process Development to lead technical transfer activities for sterile injectable pharmaceutical and medical device products while driving process robustness, manufacturing readiness, and continuous improvement across our Brighton manufacturing facility.

This is a highly visible leadership role responsible for leading Process Development activities that support new product introductions, technology transfer, process optimization, and successful commercialization while partnering closely with Manufacturing, Quality, Validation, Engineering, and other cross-functional teams.

Reporting to the Director, Pharmaceutical Technologies, the Manager, Process Development, provides technical and people leadership for product transfer and process development activities that support sterile injectable pharmaceutical and medical device manufacturing.

This role leads a team of Process Engineers and ensures that manufacturing processes are technically sound, scalable, compliant, and capable of consistently producing high-quality products. The position partners closely with Manufacturing, Quality, Validation, Engineering, Supply Chain, and other cross-functional stakeholders to support successful product launches, operational readiness, and continuous process improvement.

• Lead technical transfer activities for sterile injectable pharmaceutical and medical device products 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 ensure successful execution of product transfer activities.
• Drive process optimization, continuous improvement, and implementation of manufacturing best practices.
• Ensure compliance with current Good Manufacturing Practices (cGMP), company policies, quality standards, and regulatory requirements.
• Develop, review, and maintain Master Batch Records, Standard Operating Procedures (SOPs), validation master plans, cleaning validation documentation, containment strategies, and technical transfer documentation.
• Utilize manufacturing expertise to identify opportunities for process improvements that enhance product quality, efficiency, and operational reliability.
• Collaborate cross-functionally with Manufacturing, Quality, Validation, Engineering, and other operational teams to ensure successful product transfers and commercialization.
• Support manufacturing investigations, technical problem-solving, and implementation of corrective and preventive actions as appropriate.
• Lead training, coaching, and development of Process Engineers while promoting accountability, technical excellence, and continuous learning.
• Promote a safe working environment and reinforce Biovire's commitment to quality, compliance, and operational excellence.

• Bachelor's degree in Biology, Chemistry, Chemical Engineering, Biomedical Engineering, or another related life science or technical discipline required.
• Graduate degree in Chemistry, Biochemistry, Molecular Biology, Chemical Engineering, Biomedical Engineering, or a related life science preferred.
• Minimum 5 years of pharmaceutical industry experience.
• 2–5 years of leadership or people management experience preferred.
• Demonstrated experience supporting process development, technical transfer, or pharmaceutical manufacturing operations.
• Strong understanding of cGMP requirements, pharmaceutical manufacturing processes, and regulatory expectations.
• Experience developing or maintaining manufacturing documentation including Master Batch Records, SOPs, validation documentation, and technical transfer packages.
• Excellent organizational, communication, technical writing, and cross-functional collaboration skills.
• Proven ability to lead teams, prioritize multiple projects, and drive continuous improvement initiatives.
• Demonstrated commitment to safety, quality, integrity, and operational excellence.

• Opportunity to lead technical transfer and process development activities supporting commercialization of innovative therapies.
• High visibility and cross-functional leadership exposure across Manufacturing, Engineering, Quality, Validation, and Pharmaceutical Technologies.
• Collaborative and mission-driven GMP manufacturing environment.
• Direct impact on new product introductions, manufacturing readiness, and continuous improvement initiatives.
• Company-sponsored medical, dental, vision, and life insurance.
• Paid Time Off supporting work-life balance.
• Opportunity to build and develop a growing Process Development team.

Come join us on our mission of manufacturing safe, high-quality products that improve and save lives.