Bio Processing Scientist (Design Transfer) in Newcastle upon Tyne, United Kingdom at Leica Biosystems

Date Posted: 11/8/2019

Job Snapshot

Job Description

Job ID: ADV001171

About Us

Leica Biosystems is a global leader in workflow solutions and automation. As the only company to own the workflow from biopsy to diagnosis, we are uniquely positioned to break down the barriers between each of these steps.  Our mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence. The company is represented in over 100 countries. It has manufacturing facilities in 9 countries, sales and service organizations in 19 countries, and an international network of dealers. The company is headquartered in Nussloch, Germany. Visit LeicaBiosystems.com  for more information.


Description

Position Summary and Overview:

Support the technical transfer of new products into the operational environment. Work within a tissue culture environment to produce cell cores from human cell lines, utilizing specialized equipment such as a microtome to produce sections. This work will be to support projects in Feasibility, Development, Verification, Validation and Clinical Trials. This role is responsible for ensuring on time delivery of operational aspects of assigned projects. 


Major Responsibilities:

  • Represent Operations, working cross functionally, as core team on R&D projects.
  • Hands on manufacturing work, such as cell line growth, as required to support the transfer of the technology into operations. 
  • Support R&D to ensure smooth transfer of product into manufacture.
  • Ensure New Products flow through the manufacturing department error free and right first time.
  • Have a good understanding of Design Control processes to enable effective and compliant transfer. 
  • Adhere to all Environmental, Health and Safety Policies to ensure risk is minimized as much as reasonably practicable. 
  • Speak up to ensure any concerns around safety, quality, or process are raised to line manager. 
  • Encourage the Best Team Wins Culture 
  • Actively maintain quality standards in line with the principles of cGMP
  • Actively participate in any DBS (Danaher Business System) training/use of DBS tools to actively champion a culture of Continuous Improvement. 
  • Actively participate in Daily Management within Design Transfer.
  • Take full responsibility to ensure they are maintained to the correct standard. 
  • Maintain equipment as appropriate.
  • Any other reasonable take assigned by line manager for which the individual is deemed suitably skilled. 

Job Requirements



Qualifications

Required Skills/Experience:

  • Demonstrable experience of working within a regulated industry, preferably with experience of cGMP and FDA/MHRA inspection processes. 
  • Ability to work both as part of a team and as an individual for extended periods of time
  • Experience of working in the biotechnology section (specifically cell culture) with prior knowledge of medical device manufacture
  • An awareness of ISO 9001:13485 or cGMP processes.

Education List of Education, Certifications, Training:

  • BSc in Biomedical Science or a related scientific discipline preferred

Competencies:

  • Strong communication skills
  • High level of initiative and self-motivation 
  • High attention to detail
  • Have a sound understanding of the underlying scientific principles involved in their day to day work.
  • Show a sound understanding of daily metrics and refer to these in making decisions. 
  • Seeks out opportunities for removal of waste through efficiency improvements.
  • Comfortable using analysis tools and able to implement countermeasures to eliminate problems.

Travel % of Travel, include approximate overnight stays per week:

  • Travel requirements for this role are minimal (<10%)

Location:

  • This role shall be based at Newcastle upon Tyne

Reporting to:

  • This role reports into the Design Transfer Manager

To Apply:
Leica Biosystems is committed to attracting and retaining the most highly qualified candidates available. We firmly believe that our employees drive the success of the company. With success in mind as the ultimate goal, we strive to create and provide an environment that offers challenging, stimulating and financially rewarding opportunities.  As a Leica Biosystems employee you will be consistently challenged to deliver your best. 
If you are ready for this challenge, submit your resume for consideration.  http://www.leicabiosystems.com/about/careers/
Be sure to follow Leica Biosystems on LinkedIn!


Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We're innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you'll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.
Danaher is committed to competitive compensation that typically has key components including base salary, variable annual incentive compensation based on personal and company performance, and long-term incentive.