Title - Project Manager
Location - Princeton, New Jersey, United States (On- site)
Experience - 5+ Years
TMC USA South - East is seeking an experienced Project Manager with a background in biotechnology to lead, coordinate, and manage project timelines, budgets, and resources. This role involves working cross-functionally with research, development, regulatory, and operational teams to ensure successful project outcomes. The ideal candidate will possess strong organizational skills, an understanding of biotech or life sciences projects, generate Gap assessment reports and recommendations to proceed to Tech Transfer and experience with the project lifecycle from discovery through to market launch.
What your role looks like :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 our partners and 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
What you bring along with 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 can you expect from TMC ?
At TMC we believe that people are the driving force behind technological innovation. That is why we want to create the best possible conditions for tech talents to thrive in. We offer you a challenging and stimulating work environment in which you can be the director of your own career.
As an Employeneur you are part of our TMC family. Next to our outstanding technical expertise, fun and engagement are meaningful parts of our culture.
Why choose Employeneurship?
We are truly unique thanks to our Employeneurship model which is a true innovation for the High Technology consulting business. It is the business relationship of the 21st century for high skilled technical professionals. It is built around 5 main pillars:
- You will be a permanent employee given opportunities to support multiple projects.
- You will get the opportunity to receive a share on the profit of your work.
- We will support you with a one-on-one coaching and trainings designed to help you develop your entrepreneurial skills.
- The competence cells within TMC will provide you with a strong, meaningful and relevant network.
- The entrepreneurial lab: a playground for new ideas and a potential launching for start-ups.
TMC is an equal opportunity employer and values diversity. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.