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Senior Quality Control Associate

 
Requisition ID:  3906
Location: 

Bothell, Washington, US

Date:  Jan 17, 2023
 

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck Seattle BioPharmaceuticals (Lu-SBP), located in Bothell, Washington, is the Process Development Center of Excellence for Biologics within the global Lundbeck CMC organization. Since integrating into Lundbeck in October 2019, Lu-SBP has supported commercial launch of Lundbeck’s first biologic product (Vyepti) and advancement of a growing biologics pipeline in collaboration with our Copenhagen-based Process Science & Validation Team. The Lu-SBP team leads and supports the development of new product candidates from cell line development through commercial validation of Drug Substance and Drug Product manufacturing processes. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!

SUMMARY
Lundbeck Seattle BioPharmaceuticals is seeking a Senior Quality Control Associate to support QC testing activities for projects in clinical development from pre-Phase 1 through hand-off to Commercial QC post-PPQ.  The ideal candidate is detail oriented, organized and will have experience in a Quality Control or other scientific laboratory setting.
 
ESSENTIAL FUNCTIONS

  • QC Sample Shipping and Sample Management
    • Assist primary QC process owner with coordinating and tracking sample shipments between various departments at Lundbeck and multiple CMOs/CTLs including international shipments.
    • Assist primary QC process owner with maintaining accurate inventory of all samples in the Lundbeck QC sample library and at external GMP storage sites
    • Perform labeling and aliquoting of QC samples to support internal and external testing needs
  • QC project team support
    • Perform data entry to support evaluation and trending of assay performance and product testing results. 
    • Perform data review for in process, lot release, or stability data generated with compendial or product specific methods
    • Perform data triage upon QC receipt from CMOs/CTLs
    • Perform data verification for internal QC data/reports and regulatory filings
    • May include generation of internal reports (i.e. product shelf life reports)
    • May include serving as QC team representative on product project teams
  • Document all GMP work as described in Lundbeck SOPs and cGMP requirements

 
REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited Bachelor's Degree with 2+ years of related experience in biotechnology / pharmaceutical Quality Control, OR a combination of education and biotechnology / pharmaceutical Quality Control experience totaling 4-6 years.
  • Excellent written and oral communication skills and be comfortable taking direction from multiple QC personnel  
  • Must have a strong ability to organize and track work, as well as good attention to detail 
  • Flexible attitude with respect to work assignments and enjoy working in a rapidly changing, team-based environment 
  • Ability to interact with and support other various departmental personnel in execution of the above activities
  • 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 BS or BA Degree in life science or related field
  • Experience with Good Documentation Practices (GDP)
  • Experience with Good Manufacturing Practices (GMP) and ICH Guidelines 

 

TRAVEL

  • No travel is required for this role

 

The range displayed is specifically for those potential hires who will work or reside in the state of Washington, if selected for this role, and may vary based on various factors such as the candidate’s qualifications, skills, competencies and proficiency for the role. Salary Pay Range: $33/hour - $38/hour and eligibility for an 8% bonus target based on company and individual performance.  Additional benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision and company match 401k. Additional benefits information can be found on our site.

#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