Technical Program Manager

Sunflower Therapeutics PBC
Medford, MA | Full-time
Start Date: Summer 2024

Position Overview: Sunflower Therapeutics is currently recruiting a motivated and highly organized individual to support its mission to deliver protein manufacturing solutions that anyone can use for creating innovative new medicines, food products, and other bio-based products. Reporting to the Director of Engineering Operations, the Technical Program Manager will be responsible for planning, overseeing, and executing project-related tasks and activities to support Sunflower’s engineering operations. This individual will assist in the development, maintenance, and oversight of programs and provide technical, budgetary, and managerial support. This individual will also lead the development and management of Sunflower’s Quality Management System (QMS) to ensure compliance with industry standards and regulatory requirements. The candidate will lead the design and implementation of a robust change control program to manage engineering design changes eectively. This role requires an innovative problem-solver that can assist in strategic technical planning beyond day-to-day activities. As Sunflower grows, the Technical Program Manager will contribute to the continuous improvement of Sunflower’s engineering and system development.

Responsibilities

• Assists in planning, development, implementation, and maintenance of new and existing engineering programs, including timelines, deliverables, and budgets
• Develop, implement, and maintain a comprehensive Quality Management System (QMS) to support equipment development and delivery
• Design and establish procedures, policies, and documentation standards to ensure compliance with relevant quality standards (e.g., ISO 9001, GAMP)
• Collaborate with cross-functional teams to integrate quality processes into existing workflows and systems
• Lead the development and implementation of a structured Change Control Program to manage engineering design changes from initiation through approval and implementation
• Conduct audits and assessments to evaluate the eectiveness of the QMS and Change Control Program, identifying areas for improvement and implementing corrective actions
• Orient and train new employees on documentation and quality management operations
• Ensure timely resolution of quality issues by implementing robust corrective and preventive action (CAPA) plans
• Build and maintain a network of vendor partners for operational needs
• Champion innovation and drive implementation thereof to reduce the time and cost to develop processes for the manufacturing of biologics for patients around the world
• Support writing of reporting documents, technical documents, and any other necessary documentation
• Provides recommendations to management on the use of resources to accomplish engineering goals

Desired Qualifications

We believe the experience and capabilities outlined below will lead to success in this position. We recognize, however, that our mission to enable more proteins to reach patients and consumers worldwide is a significant challenge and will require innovative solutions. As such, we will consider how the diversity of our candidates can help us reach this mission.

• Bachelor’s degree in Engineering or a related field. Masters degree preferred
• 5+ years of relevant experience in developing, implementing, and/or working within quality management systems
• Aligned with Sunflower’s mission
• Willingness to be both a strategic leader and a hands-on problem solver
• Demonstrated leadership through careful and sensitive relationship-building with colleagues
• Experience in project management and oversight to achieve stakeholder goals, including management of complex international relationships across diverse culture-specific business practices
• Excellent analytical skills with the ability to interpret data and make data-driven decisions
• Experience in designing and implementing Change Control Programs, including documentation and process control
• Strong knowledge of quality standards and regulations relevant to the industry
• Proven track record of strong collaboration with internal and external stakeholders
• Strong analytical and organizational skills, including meticulous attention to detail and multi-tasking capabilities
• Enthusiastic, collaborative, and proactive attitude
• Ability to easily adapt to rapidly changing company and program needs
• Focus on continued skill-building and career development