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Sr Associate I, Quality Control

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Date: Sep 14, 2017

Location: Hillerod, Denmark

Company: Biogen

External Posting TitleSr Associate I, Quality Control
Job DescriptionDo you have a strong background in Bioassays and experience working with quality systems? Then you might be the person we are looking for! We are currently looking for a Senior Associate to join our QC Bioassay group in Hillerød.

You will be responsible for contributing to key functional, tactical, and operational aspects of the QC Bioassay group at Biogen. You will perform QC testing and all activities associated with executing tests in a cGMP manner, project management, initiation of process improvements, liaison for method transfer, qualification and validation activities, modeling the leadership competencies, aiding in the development of peers and performing QC approval, as required.

Primary Responsibilities

• Provide supervision and technical support as responsible scientist for bioassays with regard to testing, trouble shooting and method improvement,

• Coordinate/perform testing and review of analytical data to support timely release of drug substance and drug product and stability samples

• Ensure all testing performed in compliance with cGMP

• Support validation, transfer and/or qualification activities by review of protocols and reports

• Provide troubleshooting support for analytical instruments where needed

• Author of quality documents such as deviations, change control requests and CAPAs to ensure compliant with cGMP

• Provide technical support during audits/inspections

• Proactively identify technical gaps and areas for improvement related to quality and lead them through completion

• Participate effectively in a leadership or membership role for site cross-functional teams as a representative of the QC Bioassay laboratory

*LI-DEN2
LocationHillerod, Denmark
Job CategoryOperations, Technology & Innovation (PO&T), Quality
Requisition Number31963BR
QualificationsWe are looking for a motivated and driven team-player who has the ability to work effectively, independently and within a team framework across all business areas and levels of the organization. This requires excellent written and verbal communication skills. You should also have;

• In-depth understanding and experience, technical as well as scientific, in bioassays (including ELISA-based, Cell-based, and coagulation assays as well as qPCR methods)

• 5+ years of experience from GMP regulated laboratory

• 5+ years of laboratory experience within bioassays

• Good collaboration skills in a very dynamic environment

• Excellent communication skills in Danish and English

We also expect that the candidate has a mature leadership approach and understanding of their personal communication style and manage that effectively.
Education
• University Master Degree in chemistry, biochemistry, or equivalent
About BiogenCorporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry’s most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.

Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.


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