- Expanding biotech company
About Our Client
Our client is a multinational company expanding its activity in biologics.
- Manage CMC product development for several Biosimilar products going into and through clinical development stages:
- Ensure detailed timelines and budgets are established andrespected through negotiation with project stakeholders
- Coordinate with functional leads/line managers (R&D groups, Process Dev, Manufacturing, Quality, Regulatory Affairs, IP) and external consultants to ensure timely execution of work packages
- Upon the Biotech CMC program lead request, work with the project team to create alternative development scenarios, each comprising assessment of costs, timelines, risks.
- Manage CMC documentation (work-package reports, minutes of internal and external meetings, risk assessments)
- Support the Biotech CMC program lead in defining the CMC program strategy and related, stakeholder management (including liaison with the Global Development Team).
- Act as point of contact for CMOs/CROs and Biosimilar unit:
- Manage all aspects of project management, process technology transfer and scale up procedures (if appropriate) to CROs/CMOs
- Assemble RFP in collaboration with functional leads, CMO identification, technical/quality agreements in collaboration with QA
- Manage project CMC budget (actuals, accruals, forecast, short & long term planning):
- work in close collaboration with the controller
- Provide project team with early warnings on possible budget variances. In case of major variations (according to established governance guidelines) inform the Biotech CMC program lead.
- Challenge team members on their functional project activities to ensure efficient and cost conscientious development.
- Coordinate in close collaboration with the CMC lead the preparation and update of key project documents (CoG, qTPP, TDP, etc.)
The Successful Applicant
- BSc, MSc, PhD or equivalent in biochemical engineering, biochemistry, biology, pharmacy or related discipline.
- Minimum 5 years of relevant biologics R&D and/or CMC experience in an Biotech industrial setting.
- Experience in biosimilar development can be a plus
- Strong project management skills and master state-of-the-art project management tools & techniques. PMP can be a plus.
- Competencies: excellent planning and organizational skills, excellent communication skills, customer orientation, problem analysis and solving, results-oriented, teamwork
- 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; ICH)
- Experience in quality and technical agreement drafting (CMO)
- 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 asset
What's on Offer
Great opportunity to join a growing team for a long term assignement.