CMC Project Lead

CMC Project Lead

Sobi

Switzerland

Role & Function

The CMC Project Lead position will be responsible for the planning, coordination and reporting of CMC projects in the development phase and during the life cycle management of marketed products. The role will be translating Sobi’s growth strategy in late stage development and for marketed products into a CMC strategy and CMC milestones. The individual will interact with internal stakeholders and external partners to identify key deliverables and resource requirements. The position holder will optimize team effectiveness in achieving project objectives in alignment with budget and timeline. In a fully outsourced setting the CMC Project Lead will manage global projects in development and commercial until successful regulatory approval and during the life cycle of the product.

Key Responsibilities

  • Develop and maintain the CMC plans and timelines; set-up, monitor and control scope, deliverables, budget, and resources;
  • Collaborate with Procurement to set-up supply agreements and establish development contracts (SoW) with external partners;
  • Partner with Global Regulatory Affairs to establish the regulatory strategy and define the regulatory requirement for filling;
  • Day to day interaction with C(D)MO’s, CLO’s and further external partners managing cross-functional/company project teams;
  • Provide input to project feasibility and suggest changes to ensure successful completion of assigned projects;
  • Establish and maintain effective communication channels to provide accurate information to the Technical Operations Leadership Team, functional line management, Project Team leadership, and R&D functions;
  • Ensure coordination with internal and external partners to align efforts with SOBI’s strategy to develop, market new chemical and biological products and to maintain and supply the current marketed product portfolio.

Qualifications

  • Technical degree in Life Science, pharmaceutical technology, chemical engineering, biotechnology, at least Master level;
  • Multiple years experience in Project Management in the pharmaceutical business;
  • Strong technical background in development, analytics and GMP manufacturing of pharmaceutical products;
  • Experienced in all CMC aspects during late stage development, launch and life cycle management for biological and chemical entities;
  • Prior experience in collaboration with C(D)MO’s and CLO’s;
  • Excellent communication, negotiation and conflict management skills;
  • Demonstrated ability to think strategically, create innovative strategies, manage ambiguity and able to anticipate;
  • Excellent verbal and written communication skills in English; French, Swedish, German is a plus.

Apply Now

Don't forget to mention EuroPharmaJobs when applying.

Share this Job

More Job Searches

Switzerland     Manager and Executive     Manufacturing and Logistics     Sobi    

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

Newsletter | Recruit | Advertise | Privacy | Contact Us

© EuroJobsites 2021

EuroJobsites is a registered company number: 4694396 VAT number: GB 880 9055 04

Registered address: EuroJobsites Ltd, Unit 8, Kingsmill Business Park, Kingston Upon Thames, London, KT1 3GZ, United Kingdom

This website uses cookies to make your experience better. Continued use of this website means you accept our cookie policy.  Accept Cookies