12/01/2021 8:50:14 3001 Vlaams-Brabant

CMC and Formulation Development Program Manager


  • reMynd nv
  • 3001 Vlaams-Brabant
  • Pharmaceutical and Healthcare
  • Onbepaalde duur
  • Vast contract
  • Voltijds
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reMYND is a spin-off from the University of Leuven. It’s a clinical stage company developing treatments for Alzheimer’s, diabetes and other diseases caused by cellular dysfunction.

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Job description

The CMC and Formulation Development Program Manager will lead the CMC & formulation development for reMYND’s 5 major small molecule projects and be the subject matter expert in this area. The position will be responsible for pre-formulation studies, formulation and process development, optimization, scale-up and manufacturing, including the for each phase relevant analytics in support of reMYND’s developing pipeline of small molecule programs. The CMC and Formulation Development Program Manager must be able to collaborate effectively with a multidisciplinary internal and external team of scientists and engineers for formulation, analytics and process optimization and overall product development.

Strategic/scientific component:

  • Lead Chemistry, Manufacturing and Controls (CMC) and formulation development activities
  • Work with CMC consultants and designated international CDMOs to facilitate successful project execution, achievement of key deliverables and of budget and FTE goals
  • Serves as subject matter expert (SME) with internal team members and be able to clearly explain the purpose of experiments and experimental results to senior management: Collaborate cross functionally with internal and external stakeholders such as Discovery, Regulatory Affairs, Toxicology, Medical / Clinical and Quality
  • Prepares, reviews and/or approve study protocols, study reports, manufacturing batch records, development campaign reports, CMC regulatory submission documents and SOPs
  • Proactively demonstrates leadership by advising and sharing knowledge and expert opinions with peers and senior management

Operational component:

  • Builds project timelines and managing the critical path
  • Translates strategies into CMC operational plans
  • Develops CMC project budgets and budget forecasts
  • Develops and analyzes scenarios, risk assessment and mitigation planning
  • Participates in consultant and CRO selection activities
  • Develops, liaises with and manages resources (FTE, CRO and consultant budgets)
  • Supports monthly, quarterly and major financial budget cycles

In this position you will work with internal and external contacts: the internal drug development organization, the CMO, CDMOs. You will report into the CSO.

Profile

  • Demonstrated extensive experience in formulation/process development and scale-up of solid oral dosage forms for small molecules
  • Proven ability to interpret experimental results to form appropriate recommendations and provide guidance on next experiments
  • Understands analytical method development and can weigh if needed; as knowledge of HPLC, UPLC, LC/MS, IC, KF, particle size and Dissolution Testing
  • Clearly understands GMP and related regulatory requirements; can implement where necessary
  • Excellent command of all relevant tools and sources of information in the field of Drug Product Development
  • Experience with scientific report writing
  • Can deal with significant responsibilities and is stress-resistant
  • Excellent communication skills, strong organizational skills, the ability to multitask and effective interpersonal skills are required
  • Knowledge of and experience in small molecule drug development, specifically CMC functions, is essential, including e.g. familiarity with drug substance (essential) and/or drug product development, analytical development and stability programs, clinical trial materials, manufacturing, and quality and regulatory requirements
  • Experience in Project Management is essential
  • Experience in clinical development and clinical supplies is a strong plus
  • PhD or equivalent in a scientific discipline, or/and at least 7 years of relevant experience in the pharmaceutical industry and drug development is essential
  • Being strategic and result-oriented; team leadership and good cooperation skills are required

Questions?

Contact Elien De Durpel at 09/2425413 or via elien.dedurpel@hudsonsolutions.com

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