Senior Manager Life Cycle Project Management

Negotiable
  1. Permanent
Nyon
  1. Regulatory Affairs
Posted:19/04/2021
BBBH16367

Hobson Prior are working with a world-wide healthcare organisation whose products and services are used to help care for patients who are critically ill. Our client is looking for a Senior Manager Life Cycle Project Management to join them on a permanent basis in Nyon, Switzerland.

Job Responsibilities
:

  • Manage Life Cycle and Insourcing activities for the FKSBS Biosimilar portfolio.
  • Manage LCM and Insourcing meetings.
  • Ensure visibility of plans and changes of all LCM and Insourcing activities.
  • Ensure detailed timelines and budgets are established and respected through negotiation with project stakeholders.
  • Coordinate with functions leads (RDMS, Quality, Regulatory Affairs, IP, Sites functions) to ensure timely execution of work packages.
  • Establish & manage LCM and insourcing documentation (work-package reports, minutes of internal and external meetings, risk assessments).
  • You will support functions in defining the LCM and insourcing strategy and related stakeholder management.
  • You will support the organization in the setup of LCM activities with external partners (SoWs, budgets, SME review).
  • To act as point of contact for Insourcing & LCM activities.
  • Manage LCM budget (actuals, accruals, forecast, short- & long-term planning).
  • To work in close collaboration with the controller.
  • Challenge team members on their functional project activities to ensure efficient and cost conscientious development.
  • Provide LCM and Insourcing teams with early warnings on possible budget variances. In case of major variations inform team according to established governance guidelines.

Key Skills:

  • Robust project management skills and master state-of-the-art multi-projects & program management tools & techniques.
  • Excellent planning and organizational skills.
  • Excellent communication skills, customer orientation, problem analysis and solving, results-oriented, teamwork-oriented.

Requirements:

  • BSc, MSc, PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline.
  • Minimum 7 years of relevant biologics R&D and/or CMC experience in a Pharma/Biotech industrial setting.
  • Familiarity with current GMP guidelines.
  • Some knowledge and/or exposure to regulatory requirements and submissions (IMPD/IND/BLA) and quality requirements from the industry (GMP; FDA; ICH).
  • Experience with managing and overseeing a budget.
  • Practical experience or theoretical knowledge in some of these fields would be a strong asset: process development, analytics, technology transfer, process scale up, process validation, GMP manufacturing in the Biotech industry.
  • Fluent English is required; French is an admirable.
  • Experience in biosimilar development and/or commercialization is a plus.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

Upload CV