Biogen in Hillerød is looking for a Senior Associate, Contract Laboratory Management to provide oversight and relationship management to Contract Laboratory Organizations (CLO) and Contract Manufacturing Organizations (CMO) that perform testing for Biogen Quality Control.
You will facilitate the development and implementation of relationships with necessary CLO/CMOs to ensure Biogen commercial and/or clinical products are tested in a compliant and timely manner according to company standards, practices, and SOPs as well as ICH and FDA guidelines. This includes development of quality agreements and contracts, requesting quotes, managing purchase orders, communicating routinely with the CLO/CMOs, overseeing collection and reporting of CLO/CMO data, and reporting CLO/CMO testing metrics as needed.
Other primary responsibilities include facilitating appropriate communication between CLO/CMO testing sites and Biogen SMEs to support CLO/CMO testing and represent CLO/CMO management on cross-site and cross-functional teams. Additional responsibilities may include managing CLO/CMO testing budgets, facilitating CLO/CMO testing deviations, and managing change controls associated with CLO/CMO testing.
The reporting structure will be with a direct line into the US. A dotted line will be added into a manager in Quality Control in Hillerød, since the person will be sitting together with them and have daily interaction with them.
Location: Hillerod, Denmark
You have a minimum of 5 years experience in Contract Lab Management or QC Testing in the Pharmaceutical industry. You have strong project management skills and good knowledge of GMPs, global quality systems and FDA/EMA regulations. Knowledge of LIMS and experience in Trackwise, Oracle, and myCIMS would be helpful, as well knowledge of analytical methods and the ability to analyze data.
The right candidate has strong oral and written communication skills. You have as well strong interpersonal and organizational skills, and ability to work with multiple teams with appropriate attention to detail.
Education You have a Bachelor or Master Degree in Science (e.g., Biology, Chemistry, Biochemistry, Chemical /Biochemical Engineering, or related disciplines) with equivalent experience.
For further information please contact Eva Op De Beeck, Sr Recruiting Partner +45 7221 0860
Apply online. Your application and CV must be in English.
Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies for the treatment of neurodegenerative and rare diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.
Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for Alzheimer’s Disease, amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular atrophy and neuropathic pain amongst others.
With more than 7,000 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
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.
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