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Quality Control Specialist

 
Requisition ID:  968
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 Specialist.  Primary responsibilities will include leading assay set-up, validation, verification, and method transfer activities for diverse analytical methods used for GMP release and stability testing of Lundbeck’s biologics products at multiple external GMP contract testing labs.  This person will also write method change controls, review and approve test methods, and monitor method performance.

 

ESSENTIAL FUNCTIONS

This position will participate in or lead a wide variety of analytical activities at Lundbeck’s external contract testing labs supporting both clinical and commercial programs, including:

 

  • Support set-up of new or optimized methods at external contract testing labs in collaboration with Analytical and Formulation Development group; ensure readiness to begin GMP method transfer, verification or validation
  • Support method transfer, method validation and method verification at the external contract testing labs by writing and/or reviewing protocols and reports, and by reviewing associated raw data
  • Review and assess protocol deviations associated with method transfer, method validation and method verification
  • Evaluate method performance by trending system suitability, sample acceptance and assay control data; recommend changes to methods based on outputs of the trending
  • Participate in change control for analytical methods to ensure alignment between multiple testing sites and regulatory filings; includes initiation, review and assessment of proposed changes to test methods
  • Write and/or review test methods, including internal and external contract testing lab methods
  • Serve as a reviewer of data from contract testing labs, including in-process, lot release, stability data for BDS, DP, cell banks and reference standards
  • May represent QC on one or more project teams
  • Participate in teams to support resolution of technical issues including providing input on deviations, lab investigations and CAPAs. Effectively lead SME-based teams for issues of limited to moderate scope and complexity
  • Regularly interact with other departments, internally and externally to meet project team objectives

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • A BS or MS degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry or related field)
  •  5 - 8+ years relevant experience in biopharma QC
  • Strong technical understanding of GMP assays for release and stability analysis of monoclonal antibodies is required, including chromatographic methods, ELISAs and compendial methods.
  • Demonstrated experience with method transfer, method validation and method verification activities, including independent design of protocols.
  • Excellent 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

 

 

TRAVEL

Willingness/Ability to travel up to 10% domestically. International travel may be required.

 

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.