CMC Project Manager

☞ Light Chain Bioscience - NovImmune S.A.

View: 250

Update day: 26-03-2024

Location: Plan-les-Ouates Genève GE

Category: Planning / Projects IT - Software

Industry: Research Biotechnology Pharmaceuticals

Position: Entry level

Job type: Full-time

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Job content

Light Chain Bioscience (LCB), a brand of Novimmune SA, is a drug discovery and development company located in Geneva, Switzerland, that focuses on developing bispecific and multi-specific antibodies for the treatment of cancer and other indications, based on its proprietary kl-body platform. LCB’s current pipeline consists of several programs at various stages of development ( ).

LCB is seeking a CMC Project Manager to coordinate and monitor our outsourced CMC activities.

CMC Project Manager

Key Responsibilities
  • Manage the CMC operational aspects and monitor the out-sourced activities such as CMO, bioanalytical development, bioassay, labelling and packaging.
  • Plan and coordinate the communication internal and external for all CMC activities.
  • Work as primary liaison contact with Contract Development and Manufacturing Organization and internal Subject Matter Experts (USP, DSP, Analytical).
  • Monitor risks to ensure team engagement and mitigation plans are activated as required.
  • Ensure cross-functional communication to enable appropriate clinical and non-clinical materials demand and supply, including shipments.
  • Lead internal team meetings related to CMC activities; meeting agendas, minutes, action items and detailed project plans to ensure timelines and deliverables.
  • Responsible for documentation review and archiving.
  • Write and review CMC sections for regulatory submissions.
  • Follow-up costs plan, resources calculation and validate invoices for the overall CMC plan.
  • Lead external vendor selection process for bioanalytical assays.
  • Prepare project status summaries and supportive documentation.

Profile
  • Bachelor’s Degree in relevant scientific discipline (i.e. biology, biochemistry etc.) and a minimum 3 years of CMC project management experience in the development of antibody products
  • Proven track record of successfully working in interdisciplinary teams and planning, coordinating and leading activities simultaneously on multiple projects
  • Previous experience in supporting eCTD Module 3 regulatory submissions an advantage
  • Demonstrated ability for risk assessment and mitigation
  • Excellent communication skills, both oral and written
  • Fluent English required (oral and written), French is a plus

Interested applicants should send their CV and motivation letter, in English to click apply
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Deadline: 10-05-2024

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