CMC Project Manager at CombiGene, The Nordic region’s leading gene therapy company

Sep 15, 2020

CombiGene’s project portfolio is currently advancing rapidly. Our epilepsy project CG01 is in late preclinical phase with safety and biodistribution studies planned for 2021. Your main tasks are to be responsible for CMC in the production of gene therapy vectors at our CDMO partners and to be responsible for product-related analytical assays at our CRO partners. The work includes contacts with a variety of stakeholders such as suppliers (e.g. regulatory consultants), authorities, management and board of directors.

As CMC Project Manager, your responsibilities are as follows:

  • Responsible for CMC (Chemistry, Manufacturing and Controls) in the production of gene therapy vectors at our CDMO partners, which includes production and purification process as well as formulation of the product including need for in-process sampling
  • Responsible for the CRO performing product-related analytical assays
  • Responsible for QC analytical assays through all clinical stages and all the way to market
  • Responsible for product formulation and stability
  • Be responsible for ensuring that the product meets regulatory requirements by working together with CDMO, QA and regulatory consultants
  • Work closely with the clinical manager at CombiGene to ensure that validated analytical assays are in place to ensure the quality of the product and the injection device during storage and handling in the clinic
  • Work in close cooperation with the pre-clinical manager at CombiGene to ensure that there is material of the right quality for the toxicology and biodistribution studies
  • Updating and follow-up of CMC activities in relation to project plans

Other:

  • Present project status including risk management, budget, resources, etc. for project teams, senior executives and board of directors
  • Plan and implement production of materials for CombiGene’s epilepsy project CG01 and other projects at CombiGene
  • Write/coordinate protocols, reports, and other necessary documentation
  • Responsible for procurement and contacts with CDMO- and CRO-consultants regarding CMC and be contact person to companies operating within CMC on behalf of CombiGene
  • Maintain knowledge of regulations and standards and be responsible for ensuring that CombiGene’s CMC work comply
  • Be the company’s CMC representative in regulatory meetings with authorities such as MPA, EMA and FDA
  • Attend conferences and represent our company in smaller and larger contexts

Exact responsibilities depend on the candidate’s profile.

Education, qualifications and experience

  • PhD or MSc in natural sciences or civil engineering
  • Experience in drug production process development in biologics is a requirement
  • Experience from gene therapy is a plus
  • Experience from pharmaceutical companies
  • Experience from project management is a plus
  • Experience from selecting and contracting of subcontractors/CRO is a plus (not required)
  • Good knowledge of Swedish and English, written and oral
  • Experience with Microsoft Office, preferably Microsoft Project

Skills and competences

  • Strong ability to organize, plan and carry out activities according to defined goals and “juggle many things at the same time”
  • Create good relationships and networks with stakeholders at different levels, show interest and understanding for other people
  • Take own initiative, work independently, make quick and clear decisions
  • Great analytical ability and skill to structure and formulate information clearly
  • Learn new tasks quickly, manage knowledge and gather information to support decision-making
  • Work productively in a demanding environment and have a positive attitude to work
  • Flexible, pragmatic and creative problem solver – entrepreneur and willing to make a big impact on the company

Application

Please send your application (CV and a few words on why you are suitable for the position) to daniela.morath@combigene.com

If you have any questions about the position, please contact Jan Nilsson at: jan.nilsson@combigene.com

Please state “CMC Project Manager” as subject.

About CombiGene

CombiGene’s vision is to provide patients affected by severe life-altering diseases with the prospect of a better life through novel gene therapies. CombiGene’s business concept is to develop effective gene therapies for severe life-altering diseases where adequate treatment is currently lacking. Development assets are sourced from an external research network and developed to achieve clinical proof of concept. Drug candidates for common diseases will be co-developed and commercialized through strategic partnerships, while the company may manage this process on its own for drugs targeting niched patient populations. The company is public and listed on the Swedish marketplace Nasdaq First North Growth Market and the company’s Certified Advisor is FNCA Sweden AB, +46 (0)852 80 03 99 info@fnca.se.

 

Combigene AB, Medicon Village, SE-223-81 Lund, Visiting adress: Scheelevägen 2, Lund, Sweden

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