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Senior Quality Control Associate, Stability

 
Requisition ID:  969
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 support for the GMP stability program, including stability data coordination and review, serving as system administrator for validated stability software, and tracking stability testing metrics. This role also involves supporting routine lot release and in-process testing of Lundbeck’s biologics products at multiple external GMP contract testing labs.

 

ESSENTIAL FUNCTIONS

  • Support GMP stability program by tracking, reviewing and archiving stability data; report progress and metrics to QC management
  • Data entry and verification in stability data management software
  • Serve as a reviewer of GMP stability data including compendial and non-compendial assays; also support review of in process and lot release data as required
  • Serve as co-system administrator for stability data management software
  • 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
  • May write deviations, change controls and CAPAs

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited Bachelor’s degree or equivalent 4 years relevant work experience such as analytical development, manufacturing, quality assurance, quality control, etc.
  • 2+ years of experience in Biopharmaceutical Quality Control or analytical support
  • Working knowledge of GMP requirements, FDA and ICH guidelines is preferred including laboratory deviations and investigations
  • Able to use judgement within defined QC practices and procedures to obtain solutions
  • Ability to proactively handle multiple tasks simultaneously
  • Excellent written and oral communication skills; must possess confidence and be able to effectively communicate professionally

 

PREFERRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited BS degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry or related field)
  • Chromatography experience 
  • An understanding of routine analytical methodologies for GMP release and stability analysis of monoclonal antibodies 

 

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.