Project Manager - Site Manager at HAYS in Trenton, New Jersey

Job Description:

Your new company



Your new role


The Project Manager will be actively engaged in the selection of decentral manufacturing units, assessing the sites facility and requirements applicable to support the company's pioneering Decentralized Manufacturing model, and will be responsible for coordinating the subsequent start-up and technology transfer activities. The Project Manager is the key contact person for the manufacturing site during site selection and technology transfer and will work with a cross-functional team to drive the project.


Your role


Participation in site selection from a Tech Ops perspective, involved in:
Assessment of the manufacturing facility and capabilities of a potential partner site, including site visits
Generation of Gap assessment reports and recommendations to proceed to Tech Transfer
Act as project manager during the start-up and tech transfer phases by:
Coordinating equipment deployment and IOQ to the sites
Generation of the Tech Transfer Plan, maintenance of and oversight on the tech transfer planning
Facilitating Project Team Meetings between the Decentralized Manufacturing teams including minutes and follow-up on actions defined during these PTMs
Reporting project status and timely escalation of changes and/or constraints to Site Management team
Liaison with the Decentralized Manufacturing sites:
Maintain relationship
Monitor the manufacturing facility during clinical manufacturing operations
Coordinate change where necessary (e.g. new product introduction, ramp up manufacturing rate)
Support the writing of procedures, deviations, change controls and CAPAs where appropriate
Job requirements
Who are you?


MSc of PhD degree in life sciences, biotechnology, or related discipline
Project Management Professional certificate is preferred (PMP)
At least 5 years of experience in working with(in) Contract Manufacturing Organizations in pharmaceuticals/biotech
Strong and proven Project Management skills, including the capability to work with and develop tools to monitor and report on project status (e.g. EPPM, MS Project)
Knowledgeable on the CMC requirements applicable to ATMPs in clinical phase and beyond
Knowledge of GMP, ICH guidelines, pharmacopeia and regulatory requirements, preferably within the field of cell and gene therapy and ATMPs
Strong interpersonal, verbal and written communication skills
Ability to be flexible with changing priorities in a dynamic environment
Self-driven and a positive can-do mindset, without compromising quality
True team player, with excellent communication skills
Fluent in English



What you'll need to succeed



What you'll get in return



What you need to do now


If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.


If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.


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#1167560 - Michal Mercier