Job Description
About This Role
You, as our Senior Associate I - Quality Control, will be responsible for contributing to tactical and operational aspects of the Quality Control group at the Biogen Laboratory in Villa Soldati CABA, Buenos Aires, Argentina. Will also be accountable for, but not limited to:
- Performing QC routine testing, and all activities associated with executing this testing in a cGMP manner (Routine microbiological and/or physico-chemical testing of finished product for commercial release).
- Ensuring adherence to all regulatory licenses and regulations, serving as a subject matter expert in multiple disciplines, interfacing with key Quality Assurance and Global Quality Control, Supply Chain, Regulatory Affairs and coordination of investigations impacting Quality areas.
- Providing technical support as a subject matter expert during internal and external inspections.
- Coaching and continuous improvement for all Quality Systems cross-functionally.
- Authors or reviews controlled documents, investigational protocols, investigational reports, change control requests, validation protocols, validation reports, exception reports according to applicable procedures.
- Leads the execution of method transfer, method development, method qualification, analytical improvement projects and validation of analytical methods in collaboration with the Analytical Technology/Development group.
- Supporting the management team to ensure that laboratory and Quality systems within the department remain in compliance with Biogen and industry standards.
Qualifications
- Pharmacy, Chemistry or Biological Science degree.
- English (intermediate to advanced level - spoken and written)
- Minimum of 5 years of experience in Quality Control.
- Distinguished experience with chemistry testing is mandatory.
- Experience in pharmaceutical companies (human health) is required.
- Based in Villa Soldati CABA, Buenos Aires -- Argentina
Additional Information
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, 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. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters 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.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
