Technical Transfer Project Manager 2

The businesses of Merck KGaA, Darmstadt, Germany•Temecula, CA

About The Position

We are seeking a highly motivated and experienced Project Manager II to join our Technical Transfer and Data Management team. This pivotal role will support our New Product Introduction (NPI) process, ensuring the accurate and efficient transfer of new product information from conceptualization and development into a commercialized manufacturing environment. The successful candidate will serve as a core member of the NPI project team, collaborating closely with Research & Development (R&D), Marketing, Quality, and Manufacturing to ensure successful and sustainable product development.

Requirements

Bachelor’s Degree in a Life Science discipline
5+ years in the bioscience industry
3+ years working in a manufacturing environment
OR
Master’s Degree in a Life Science discipline
Bioscience industry experience

Nice To Haves

Proficient in MS Office (Word, Excel, PowerPoint) and familiar with manufacturing ERP systems like Oracle and SAP.
Basic knowledge of laboratory techniques, including buffer/media preparation, cell culture, protein purification, Western Blotting, and sterile techniques.
Understanding of new product development processes using Stage Gate methodology and familiarity with PLM software such as Accolade, At Task, and Planisware.
Strong project management skills across various scientific disciplines with effective communication abilities for both internal and external collaborations.
Capable of facilitating the transfer of new products to manufacturing in compliance with established regulations.
Skilled in problem-solving through technical knowledge and experience, with the ability to analyze information and make independent recommendations.
Adaptable to rapidly changing business circumstances, thriving in dynamic environments while maintaining attention to detail.
Highly collaborative and team-oriented, with the ability to manage time effectively and work with minimal supervision.

Responsibilities

Manage multiple New Product Introduction (NPI) projects, focusing on scheduling, leadership, and effective communication through team meetings.
Work independently with minimal supervision while efficiently managing workload.
Consult regularly with R&D, Quality, and Operations to ensure adherence to processes, budgets, and timelines.
Collaborate with teams to finalize all documentation required for product launches.
Continuously monitor and improve the NPI process in partnership with cross-functional teams.
Coordinate with Planning Partner to ensure timely product releases and optimal inventory levels.
Ensure compliance with quality and regulatory standards, including cGMP, FDA, and OSHA, while overseeing documentation for ERP integration.
Participate in special projects and investigations to support continuous improvement and compliance with internal quality systems.
Perform essential functions of the job, including extended periods of working with video display images and communication in both written and oral English.
Repetitive motions with hands for tasks such as typing and data entry.