Senior Technical Development Expert

5 days ago


Cambridge, Cambridgeshire, United Kingdom Healthcare Businesswomen's Association Full time
Job Overview

As a seasoned professional, you will be responsible for leading the development of cell therapy processes and overseeing project activities within the Process Development line unit. With expertise in cell therapy development processes and knowledge of state-of-the-art technologies and equipment, you will ensure compliance with quality principles and cGMP practices.

Key Responsibilities

* Develop and execute project strategies aligned with the technical development plan (TDP) and represent the project sub-team discipline in the CMC team as a core member.
* Set priorities and objectives within the Process Development sub-team in alignment with the TDP and CMC objectives, and update the CMC team on technical issues, risks, and mitigation strategies.
* Oversee study design, provide guidance to functional leads (FLs), and ensure adherence to project development strategy.
* Track project progress according to defined timelines, identify roadblocks/risks and issues, develop solutions and mitigation plans/scenarios, and proactively report them to respective stakeholders and governance boards.
* Compile and provide financial forecasts for project-specific development activities needed to reach program milestones.
* Manage project-specific compliance aspects.
* Assess, consolidate, and monitor resource needs and timelines for assigned projects.
* Stay at the forefront of scientific and technical trends in the discipline through literature and participation in conferences and workshops.

Minimum Requirements

* University degree in biotechnology, pharmaceutical technology or similar discipline.
* Strong understanding of cell therapy development processes, good knowledge of state-of-the-art cell therapy technologies & equipment, and knowledge of ATMP-related health authority regulations.
* Proven leadership skills with experience in navigating complexity and ambiguity, strong communication & presentation, organization, and planning skills, excellent time management and planning abilities; demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset; advanced coaching skills.
* Strategic thinking and planning with confident risk management including quality & safety, resources, and budget planning.

Salary:
$120,000 - $150,000 per year

Benefits

* Competitive salary and benefits package
* Opportunities for career growth and professional development
* Collaborative and dynamic work environment
* Recognition and rewards for outstanding performance

Why Join Us?

The Healthcare Businesswomen's Association is committed to fostering a diverse and inclusive workplace that reflects the world around us and connects us to the patients, customers, and communities we serve.

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