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Silence Therapeutics

CMC Project Manager

20.09.2021 /

Role Overview

The position is part of the CMC Manufacturing area responsible for outsourced activities including development, production, analytics, up-scaling, validation, technical transfer of parenteral drug products (based on RNAi) for clinical and prospectively commercial purposes. The responsibility includes generation of related documentation to support regulatory processes.

The position comprises significant external contact to Contract Manufacturing Organisations (CMOs), understanding of CMC regulatory and GMP requirements and watchful care (oversight) of outsourced CMC activities.

Key Responsibilities

Working Relationship:

  • Internal contact points: CMC Team, Development Program Oversight, Drug Discovery, Non-clinical Development, Clinical Operations, Regulatory Affairs
  • External contacts: CMOs, Partners, Consultants, Regulatory Authorities

Principal duties and responsibilities:

  • Build and maintain knowledge within Silence Therapeutics of parenteral RNAi drug development and production
  • Creation, review, administration of plans, protocols, records, reports, SOPs, risk assessments, dossiers, contracts, presentations related to development, production, analytics, quality assurance, supply chain activities
  • Contribute to CMC documents (IMPDs, INDs, Briefing Documents) for regulatory submissions
  • Collection and interpretation of data from various external and internal sources
  • Participate in the design of manufacturing processes, analytical procedures and programs, specifications, process optimisation, scale-up and technology transfer for clinical development and commercialisation
  • Contribute to risk assessments, identifying critical process steps
  • CMC project specific activities covering the whole supply chain from raw materials, intermediates and released final drug product
  • CMO contact
  • Act as back-up for other CMC team members
  • Converting project goals into CMC work packages/action plans
  • Execution of project activities according to time, budget and quality

Person Specification

  • University degree in Chemistry, Pharmacy or a similar natural science, preferably PhD
  • 2 – 5 years of experience in pharmaceutical or biotech industry
  • Expertise in either one or several of the following areas: development, manufacture, analytics of parental drug products, oligonucleotide synthesis, peptide synthesis, oligonucleotide analytics, peptide analytics
  • Understanding of drug development
  • Experience including production scale-up, manufacturing process validation, analytical validation and/or preparing complex CMC-related documents for regulatory submissions would be a plus
  • Project management knowledge
  • Passion for creation, review, administration of documents
  • Sense for practicality, identifying relevant details, problem solving
  • Fluent in English
  • Experience in Risk Management processes
CMC Project Manager

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