Site Program Manager

Merck Serono S.p.A.; Modugno; In loco; EUR 50.000 - 75.000; Tempo pieno

Descrizione del lavoro

A leading company in the pharmaceutical sector seeks a Senior Program Manager to oversee technology transfer and lifecycle management of drug products. The role requires excellent communication skills, project management capabilities, and a strong understanding of drug product life cycles. Candidates should have a scientific degree and relevant experience in a similar position.

Competenze

• At least 2 years in a similar role with a minimum of 4 years of experience.
• Strong understanding of drug product life cycles.
• Fluent in English, both written and spoken.

Mansioni

• Lead and coordinate the CMC roadmap and project milestones.
• Ensure compliance with Health Authorities' guidelines.
• Prepare comprehensive technical documentation for pharmaceutical processes.

Conoscenze

Communication

Project Management

Risk Management

Technical Documentation

Collaboration

Process Improvement

Formazione

Scientific Degree

Descrizione del lavoro

As Senior Program Manager, you'll be the linchpin for Technology Transfer (TT) and Life-Cycle Management (LCM) of drug products, ensuring alignment with site and global strategies. You'll be the central point of contact within the CMC Team, guaranteeing seamless communication and information flow. You'll lead and coordinate the CMC roadmap, identify project milestones, and monitor progression, all while contributing to the site budget with local project cost information. You will also be instrumental in identifying and managing project risks and issues. Your responsibilities include leading change control for TT and LCM projects, designing new processes, and preparing all necessary technical documentation. You will support the planning and execution of engineering, PPQ, and commercial launch batches, contribute to CMC dossier preparation, and ensure timely responses to Health Authorities. Finally, you'll help define process control strategies and drive continuous process improvement, always maintaining compliance with Health Authorities' guidelines and upholding Health and Safety rules.

Who You Are

• Scientific Degree
• At least 2 years in a similar role on a minimum of 4 years of experience
• Strong understanding of drug product life cycles.
• An exceptional communicator, adept at fostering collaboration across teams.
• Highly organized and detail-oriented, capable of managing complex projects.
• Proactive in identifying and mitigating potential project risks.
• Experienced in preparing comprehensive technical documentation for pharmaceutical processes.
• Committed to maintaining the highest standards of quality and compliance.
• Fluent in English, both written and spoken

J-18808-Ljbffr