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Senior Quality Control Specialist

 
Requisition ID:  3723
Location: 

Bothell, Washington, US

Date:  Nov 17, 2022
 

SUMMARY:

 

Responsible for GMP assay support for biologic products including GMP release and stability testing of Lundbeck’s products at multiple external CMOs/contract labs.

 

ESSENTIAL FUNCTIONS:

  • Lead a wide variety of analytical activities at Lundbeck’s CMO/contract labs, including:
  • Represent QC on one or more CMO/external lab project teams
  • Serve as a reviewer of data from Lundbeck’s contract testing labs, including characterization, lot release and stability data of QC in-process and release data for BDS and DP
  • Drives results with external labs to address any technical or compliance issues
  • Support method transfer and method validation by reviewing protocols, reports, and raw data (in collaboration with Analytical Development, global Lundbeck affiliates, and Health Authority laboratories)
  • Write and evaluate deviations and change controls
  • Evaluate method performance by trending system suitability, sample acceptance, and assay control data
  • Participate in teams to support resolution of technical issues including providing technical input on deviations, lab investigations, and CAPAs
  • Lead SME-based teams for issues of moderate scope and complexity
  • Collaborates with other departments, internally and externally to meet project team objectives
  • Assist in the technical growth and development of others on the team

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

 

  • Accredited Bachelor’s degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry, or related field)
  • 6+ years GMP Quality biopharmaceutical experience
  • Experience working in a Quality Control group, with an excellent working knowledge of GMP requirements, FDA, and ICH guidelines
  • Strong understanding of GMP assays for release and stability analysis of monoclonal antibodies
  • Ability to work independently, and to proactively prioritize and accomplish multiple tasks simultaneously
  • Excellent written and oral communication skills, ability to interact effectively internally and with personnel at multiple CMOs/contract labs / external partners located in the US and internationally
  • The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation.

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited master’s degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry, or related field)
  • 8+ years GMP Quality biopharmaceutical experience 
  • Experience with GMP testing of medical devices
  • Experience with GMP testing for commercially approved biologics in the USA and globally

 

TRAVEL

  • Willingness and ability to travel up to 10% domestically and / or internationally

#LI-LM1, #LI-Hybrid

 

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.
 

 

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

 

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.


 

About Lundbeck

About Lundbeck

Tirelessly dedicated to restoring brain health, so every person can be their best.

With too many people living with brain diseases around the world, our purpose couldn't be more important or more worth striving for. Every day we work tirelessly to change the outcome for these people. We are a community of specialists fiercely dedicated to restoring brain health, drawing on, and embracing, the uniqueness of every employee.

Our global footprint

Our approximately 5,300 employees in more than 50 countries are engaged across the entire value chain throughout research, development, production, marketing, and sales. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for brain diseases for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France and Italy. Lundbeck generated revenue of DKK 16.3 billion in 2021 (EUR 2.2 billion; USD 2.6 billion).  

For additional information, we encourage you to visit our corporate website www.lundbeck.com/global, and connect with us on Instagram @h_lundbeck, Twitter @Lundbeck and via LinkedIn