Manufacturing Sciences SME

In this position, you will play a key role in the successful integration and start-up of the novel single-use technologies (SUT) facility for manufacturing of recombinant products at the Thermo Fisher Scientific site in Lengnau (BE), Switzerland. You will support us in tech transfer activities for manufacturing processes running in both, the large-scale stainless-steel and the SUT facility. Embedded in a diverse team of experts, the position holder handles a range of questions and topics with a high level of technical proficiency to build a pioneering production site for biologics in the heart of Europe to serve our customer’s needs.

Your Key Responsibilities:

• Acts as SME on single-use upstream and downstream processing, finding opportunities and tackling challenges for the manufacturing of biologics
  Prepares, participates in and coordinates process transfer and implementation activities in cross-functional teams across Manufacturing Sciences, internal and external collaborators
• Leads the management of process deviations and change controls of moderate to high complexity within area of responsibility
• Continuous improvement: contributes to trending and evaluating process data, proposing, and implementing cGMP and business improvement initiatives in their field of expertise
• Represents Manufacturing Sciences in multi-functional teams (Quality, Engineering, etc.), including customer meetings
• Champions and maintains effective working relationships with a variety of collaborators and customers within and outside of the department
  Occasional international travel (overall <5% per year) for technology and knowledge exchange within Thermo Fisher Scientific and/or customers

Requirements / Experience & Education:

• Ability to work both independently and in cross-functional teams in a fast paced, multifaceted environment
• Strong problem-solving skills and the desire to learn and use corporate tools such as Practical Process Improvement (PPI)
• Proficient (oral/written) in English (must) and German (desirable)
• Excellent computer and software skills, especially with the Microsoft Office Suite
  Proven presentation and communications skills, technical writing ability, and an attention to detail

Education and Key Knowledge Areas:

• Master or PhD degree in biotechnology, chemical engineering, life, or food sciences
• A proven experience in biopharmaceutical process development or tech-transfer related functions within pharma, biotech, biochemistry, or food industry required
• A minimum of 2 years of experience in successfully qualifying, running, and/or troubleshooting single-use technologies for biologics
• Profound knowledge of cGMP guidance applicable to pharmaceutical manufacturing