• Head of Biopharmaceutical Process Development


• CMC Project Manager and Project Lead Novimmune


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• Archivist (For an initial period of 6 months)


• Head of Purification & Drug Product Development


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• Purification Development Research Technician in Bioprocess R&D


• Project Manager (based in Basel)


• Clinical Trial Assistant (based in Basel)


• Clinical Science Leader/Medical Director (Basel)


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CMC Project Manager and Project Lead Novimmune

CAREER OPPORTUNITY

CMC Project Manager and Project Lead

Novimmune SA is a drug discovery and development company located in Plan-les-Ouates (Geneva) and Basel that focuses on developing antibody-based drugs for the treatment of inflammatory diseases, immune-related disorders, and cancer. The pipeline is a balance of preclinical and clinical compounds, specific for clinically validated and novel targets. The company has been purposefully targeting a number of orphan drug indications, with the express hope of eventually providing safe and effective treatment options to some of the often neglected populations suffering from rare diseases.

Novimmune is seeking a CMC Project Manager and Project Lead, based in Plan-les-Ouates (Geneva), who will build and implement the CMC Project Plan based on the Global Strategy and will also act as CMC lead for one late stage project.

Key Responsibilities: 

• Manages the CMC project schedule with a focus on effective planning, coordination of activities and communication


• Monitors project resources and cost, including budget preparation, forecast and invoices for internal and outsourced activities


• Creates and maintains detailed project plans to ensure clarity on timelines and deliverables


• Aligns project activities with the Global Product Development Plan, includes the planning of any necessary changes to the CMC deliverables


• Acts as a liaison for main stakeholders and external suppliers and coordinating the generation of the required contractual documentation and/or agreements


• Ensures cross functional communication to allow clinical and nonclinical material demands are appropriately planned and delivered, according to the required quality standard


• Leads and facilitates CMC and cross functional team meetings, publishes clear and concise meeting agendas, minutes and action items and drives decision making


• Define the technical scope of the project and the strategy to be taken to achieve the next Project milestone


• Take key strategic decisions with respect to Scientific direction and technical approach to be taken to deliver the CMC objectives


• Approve key project documentation - e.g Specifications, Process Descriptions, Protocols, Master Batch Records


• Inform the global project team and the Head of Department about CMC activities and status, highlighting any risks and mitigation actions to be taken

Education / Qualifications:

• Bachelor’s Degree required, preferably in a scientific discipline.


• At least 3 years of Project management experience, of which preferably 2 years of experience in CMC are required.


• 5 years CMC experience in Biopharmaceutical product development and validation (e.g. process characterisation studies)


• Ability to work interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects


• Previous experience in supporting eCTD Module 3 regulatory submissions would be an advantage


• Strategic thinking, maintaining awareness of business impact


• Ability for risk assessment and mitigation


• Excellent communication skills, both oral and written


• Fluency in English is required (oral and written). Good oral knowledge of French would be an asset.

Interested applicants should send their CV, motivation letter, copies of diplomas and work certificates in English to  hr-recruitment@novimmune.com with a reference to the following job code in the subject line: CMC-PMPL-2019