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).
