Senior Quality Control Specialist
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 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. Join us on our journey of progress & innovation dedicated to addressing the vast unmet medical needs associated with brain disease!
Responsible for GMP assay support for biologic products including GMP release and stability testing of Lundbeck’s products at multiple external CMOs/contract labs.
Participate or lead a wide variety of analytical activities at Lundbeck’s CMO/contract labs, including:
- May serve as the Stability Coordinator for commercial stability protocols
- Represent Quality Control (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 a minimum of 6 years relevant work experience OR an accredited master's degree with a minimum of 4 years of relevant work experience OR a combination of education and experience totaling 10 years
- Experience working in a QC group, with an excellent working knowledge of GMP requirements, FDA and ICH guidelines
- Strong understanding of GMP assays for release and stability analysis of biologics
- 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
- 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 MS degree in a scientific discipline (Chemistry, Biochemistry, Biology, Analytical Chemistry or related field)
- Experience with GMP testing for commercially approved biologics in the USA and globally
- Domestic or international travel may be required.
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.