What are the responsibilities and job description for the Technical Transfer Project Manager position at Kindeva Drug Delivery?
Kindeva Drug Delivery is a leading global contract developer and manufacturer (CDMO) with expertise in delivery platform technologies. We partner with customers to improve patient outcomes worldwide.
ROLE SUMMARY
The Technical Transfer Manager serves as the primary contact for a portfolio of CDMO clients, managing all aspects of technical transfers from scope development to commercial supply readiness. This role leads cross-functional project teams and collaborates closely with Technical Process Engineers, Technical Transfer Analytical teams, Quality, Commercial, Manufacturing, and other key functions to ensure successful execution of transfer activities.
The Technical Transfer Manager is responsible for driving project execution, including managing timelines, budgets, risk mitigation, and project milestones. This role ensures that technical transfer activities meet regulatory and client requirements, while facilitating effective communication, governance structures, and routine project reviews. With a focus on operational precision and technical excellence, the TTPM works to streamline processes, resolve technical challenges, and ensure efficient product transfers, ultimately supporting reliable and consistent manufacturing outcomes.
ROLE RESPONSIBILITIES
Executes and manages technical transfer activities, including project planning, governance, and routine operational communications/meetings with clients and internal stakeholders.
Facilitates client communications related to project status, technical updates, escalations, and critical project milestones.
Pursues individual development and technical training to enhance expertise in technical transfer and project management.
Delivers on project goals and accountabilities based on defined objectives and key performance metrics.
Collaborates and communicates with cross-functional teams including Technical Process Engineering, Tech Transfer Analytical, Quality, Commercial, and Manufacturing, ensuring alignment and execution of transfer activities.
Promptly identifies and escalates potential issues to Operations and Quality leadership to mitigate risks and maintain compliance.
Leads and organizes technical product transfers into manufacturing, managing all relevant documentation, validation, and regulatory requirements.
Interfaces with clients and internal teams to ensure comprehensive and timely transfer of product and process information.
Develops and maintains project tracking tools, schedules, process flows, and Gantt charts to support project kickoff meetings and overall transfer management.
BASIC QUALIFICATIONS
Sciences, Project Management, or a related field. Advanced degree (e.g., M.S., MBA) preferred. PMP certification desirable.
3-5 years of experience in cGMP environments within the biotech, pharmaceutical, or bio-pharmaceutical sectors, spanning pre-clinical to commercial phases, or equivalent experience managing technical transfers, commercial operations, or complex client projects.
Strong understanding of business and operational planning, forecasting, and the impact of demand planning on biotech/pharmaceutical manufacturing operations.
Experience working with regulatory bodies, including FDA inspections, is highly desirable.
Exceptional interpersonal and collaborative skills, facilitating effective cross-functional teamwork with Technical Process Engineers, Quality, Analytical, Manufacturing, and client-facing teams.
Excellent verbal and written communication across diverse stakeholders, ensuring clarity and alignment throughout complex projects.
Independent and proactive decision-making ability with a focus on compliance, risk identification, and mitigation strategies.
Track record of accountability and delivering results within project timelines, demonstrating a strong delivery-focused mindset.
