Process Development Manager

Key Responsibilities

• 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.

What You Bring

• 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.