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Senior Quality Control Specialist

 
Requisition ID:  1504
Location: 

Bothell, Washington, US

Date:  Jan 7, 2021
 

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 Late-Stage Development and Production groups. 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.
 
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of 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.
 

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:

  • Participate or 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
  • Coordinate with external labs to address any technical or compliance issues identified during routine data review 
  • May support method transfer and method validation by reviewing protocols, reports and raw data (in collaboration with Analytical Development)
  • 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 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:

  • Accredited Bachelor’s degree with 8+ years GMP Quality experience OR an accredited Master's degree with 6+ years GMP Quality experience OR a combination of education and GMP Quality experience totaling 12 years
  • 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 parnters


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • Accredited Bachelor's or Master's degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry or related field)
  • Experience with ELISA methods 

 

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.
 
Millions of people worldwide live 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 5,800 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 R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 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.