Head of Programs (Analytical Development), Immunotherapy

  • Location

    Singapore

  • Sector:

    Life Sciences

  • Job type:

    Permanent

  • Salary:

    S$7000 - S$10000 per month

  • Contact:

    Abhik Damani

  • Contact email:

    abhik.damani@voltasia.com.sg

  • Job ref:

    BBBH8863_1610599570

  • Published:

    9 months ago

  • Expiry date:

    2021-02-13

My client is a leading name in the biotechnology industry and is going through a period of rapid expansion. To cater to this, a new Process and Analytical Development Program Manager role has been created

  • Global Name
  • Innovative Products
  • Next-Gen Technology

The incumbent will work with MSAT, PD, Manufacturing, and other stakeholders to support, coordinate projects and ensure deliverables are met.

Responsibilities

  • Assume responsibility for ensuring successful development of manufacturing processes and technology for cell therapy products
  • Define project plans, scope, objectives, and resourcing
  • Facilitate close partnership with internal research and academic collaborator groups to optimize cell therapy manufacturing processes, and develop next-generation T cell therapies
  • Work with CMC, MSAT and QC teams to transfer analytical methods and manufacturing processes to GMP manufacturing
  • Utilize project management practices and tools in managing the projects
  • Develop risk assessment and mitigation strategies to proactively anticipate potential risks and impacts and to facilitate resolution of issues effectively
  • Prepare and oversee the dissemination of project related updates to both internal and external stakeholders
  • Develop executive reporting materials: project updates, potential risks and gaps, risk mitigation and contingency plans
  • Facilitate and host regular meetings within the Process and Product Development groups, and cross-functionally with other stakeholders (research group, academia, other external collaborators etc.)
  • Prepare protocols, reports, technology transfer documentation, regulatory documents supporting IND, clinical trials and BLA
  • Work with finance and within team to oversee the operating budget for product/ process development activities, monitor and control budget and expenditure

Requirements

  • PhD in Life Sciences, Biotechnology with at least 5 - 7 years' experience
  • Prior research or post-doc experience in cancer biology, cancer immunology/immunotherapy/oncology or equivalent
  • Experience with cell therapy will be a plus
  • Basic knowledge of GMP, GCP, and CMC & QA guidelines
  • Experience working in project management, with experience with supply chain/vendor management
  • Foundational knowledge in the development life cycle of immunotherapies
  • Highly adaptable and able to multitask
  • Strong verbal/ written communication skills
  • Strong interpersonal skills and a team player, able to effectively work within and across teams, and in communication to various stakeholders
  • PMP certification or with strong project management skills desired
  • Highly developed inter-personal skills and verbal/written communication

Please send your resume in WORD format by clicking the apply button below or contact Abhik Damani on +65 6701 1527 for a confidential discussion. Please note that only short-listed candidates will be contacted. CEI Reg. Number R1544061 (Abhik Damani).