Method Development Scientist to Bio-Works
Bio-Works Technologies AB / Kemistjobb / Uppsala
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hela Sverige Visa alla jobb hos Bio-Works Technologies AB i Uppsala Bio-Works is looking to further strengthen our strategic position in Life Science by adding a Method Development Scientist to the Process & Custom Product Development team. In this role you will oversee the planning, execution, and implementation of method development projects. If you have effective communication skills for effective liaison and teamwork - you might be who we are looking for!
ABOUT THE ROLE
In this role, you will develop, optimize, validate, and transfer analytical methods to QC (Quality Control). The work area and key responsibilities are designing, undertaking, and analyzing information from controlled laboratory-based investigations, experiments, and trials. As a Method Development Scientist, you will focus on developing methods for characterization and QC of chromatography resins, column packing methods (or other devices), as well as generating innovative ideas and intellectual property. You will also train and support partners, customers, and colleagues within your area of expertise.
In your day-to-day work you will, among other things;
• Plan and perform projects and experimental work
• Perform characterization of resin and columns in Development projects
• Lead and perform analytical method development and validation to ISO quality standards regulations (ISO 9001:2015)
• Design and perform method qualification protocols/experiments
• Author and review standard test methods and reports
• Maintain lab equipment by following appropriate calibration and maintenance activities
• Participate/Lead technical discussions with internal and external stakeholders and support errands (CC (Change Control), NC (Non-Conformity), etc.
• Review and evaluate new methodologies/techniques to add to laboratory capabilities
• Develop and execute analytical methods for the stability evaluation of agarose resins, and write regulatory support files (RSF)
• Write and review analytical development reports, assays, and process validation reports (including IQ, OQ and PQ) and other technical documents for technical correctness and regulatory compliance
• Prepare, evaluate, and present data to cross-functional teams
• Apply statistical methodologies to validate and interpret the results of data analysis
The Process & Custom Product Development team consists of you, our Sr. Development Scientist, two Process Development Engineers and a Process Technician. Your manager will be the Head of Process & Custom Product Development who is also a part of the team, of course.
REQUIRED AND DESIRED BACKGROUND
• A PhD's degree in analytical chemistry or similar with at least 1-2 years of recent industry experience in the field or a master's degree in analytical chemistry or similar with at least 3-5 years of recent industry experience in the field.
• Demonstrable recent experience (minimum 2-3 years) in IQ, OQ, PQ, and method validation and successful transfer to QC department.
• Demonstrable recent experience (minimum 2-3 years) in analytical method development, transfer, and validation following ISO quality standards regulations (ISO 9001:2015, Pharma GMP).
• Demonstrable recent experience of applying statistical methodologies to validate and interpret the results of data analysis.
• Experience with using and developing methods in Unicorn software for ÄKTA systems is a requirement.
• Experience in column packing development is a plus.
• Business fluency in Swedish and English.
• Excellent organizational skills and the ability to work on several tasks or projects concurrently.
• The ability to work well independently, with minimum supervision.
• The ability to adequately communicate in written and oral form.
To be successful in this role, you need a proactive attitude focused on identifying problems and finding solutions and showing high personal credibility and integrity. You also need a precise and analytic mindset as well as a high sense of ownership and accountability. And finally, you need to have a bridge-building perspective and be able to great good teamwork in cross-functional, multicultural, and international teams.
WHAT DO WE OFFER?
In addition to a fun role, you are offered the opportunity to enter an exciting company under development with cheerful and competent colleagues. We offer you flexibility in the role and you can work from home when your tasks allow it and adjust your working hours so that your life at home also flows smoothly. We have breakfast on Mondays, fika on Fridays and are also good at doing other things together - such as lunches, afterwork and other activities.
We of course also have good benefits such as 30 days of vacation per year, ATF-hours (shortening of work hours) which we spread out over the year for some extra time off, wellness benefits, occupational pension, insurances and more. Bio-Works has a collective agreement according to IKEM.
GOOD TO KNOW
Start: According to agreement
Form of employment: Permanent employment (6-month probation)
Scope: Full-time 40h/week (100%)
Location: Uppsala (Uppsala Business Park)
APPLICATION
Last application date is 2023-07-30. We do not accept applications via e-mail. We will process applications continuously so please apply as soon as possible. The position requires you to be a citizen in the EU/EEA/Switzerland region or to have the authority to work in Sweden without need for a work permit.
ABOUT BIO-WORKS
Bio-Works enables scientists to achieve their purification goals, from laboratory research to large scale bioprocess production. Our vision is a biotech industry that embraces, develops, and builds on new methods and novel ideas. WorkBeadsTM, Bio-Works' next-generation, agarose-based products, are used to purify proteins, peptides, and other biomolecules, resulting in purer therapies and safer diagnostics. Through collaboration with customers and partners, we develop purification solutions that make important medicines available and accessible to everyone.
Ersättning Lön enligt överenskommelse
Så ansöker du Sista dag att ansöka är 2023-07-30
Klicka på denna länk för att göra din ansökan Omfattning Detta är ett heltidsjobb.
Arbetsgivare Bio-Works Technologies AB (org.nr 556935-3559),
https://www.bio-works.com/ Arbetsplats Bio-Works
Jobbnummer 7949714
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