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Senior QC Associate

 
Requisition ID:  967
Location: 

Bothell, Washington, US

Date: 
 

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global pharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world’s most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

 

In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP).  The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.   

 

SUMMARY

Lundbeck Seattle BioPharmaceuticals is seeking a highly motivated individual to join the Quality Control department as a QC Senior Associate.  Primary responsibilities will include data coordination and archival, data review, data verification and data trending for a diverse variety of analytical methods used for lot release and stability testing of Lundbeck’s biologics products at multiple external GMP contract testing labs. This role also involves writing deviations, change controls, and trending of method performance data.

 

ESSENTIAL FUNCTIONS

This position, participates in a wide variety of analytical activities supporting both clinical and commercial programs, including:

 

  • Review GMP data from contract testing labs, including in-process, lot release and stability data for BDS, DP, cell banks and reference standards; may also review raw data generated during method validation and method transfer
  • Track receipt, review and archival of in-process and lot release data; report progress and metrics to QC management
  • Create data summaries including COAs and COTs
  • Evaluate method performance by trending system suitability, sample acceptance and assay control data
  • May represent QC on one or more project teams as a primary contact and provide oversight for outsourced QC testing at GMP contract labs/CMOs
  • Participate in teams to support resolution of technical issues including providing input on deviations, lab investigations and CAPAs. Effectively participate in SME-based teams for issues of limited to moderate scope and complexity
  • Regularly interact with other departments, internally and externally to meet QC and project team objectives
  • May author QC SOPs and other GMP documentation such as technical reports; perform data verification for technical reports

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • A BS or BS degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry or related field)
  • 4+ years relevant experience in Biotech Quality Control
  • Technical understanding of GMP assays for release and stability analysis of monoclonal antibodies is required, including chromatographic methods, ELISAs and compendial methods.
  • Working knowledge of GMP requirements, FDA and ICH guidelines as they relate to analytical methods
  • Previous experience with initiation and review of change controls and deviations
  • Ability to work independently, and to proactively prioritize and accomplish multiple tasks simultaneously
  • Excellent written and oral communication skills; ability to interact effectively both internally and externally

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify. 

Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

An estimated 700 million people worldwide are living with brain diseases and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases – we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind.
Our approximately 5,000 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing and sales. Our pipeline consists of several late-stage development programs and our products are available in more than 100 countries. Our research center is based in Denmark and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 18.1 billion in 2018 (EUR 2.4 billion; USD 2.8 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Twitter at @Lundbeck and via LinkedIn.