Lundbeck Seattle BioPharmaceuticals

Senior Quality Control Associate

Location: Bothell, Washington, US

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.

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.

APPLY:

Please apply to Req ID 3906 via this link

Lundbeck Seattle BioPharmaceuticals
Reference Job Code: 3906

Lundbeck Seattle BioPharmaceuticals is an Equal Opportunity Employer

Submitted: 01/28/2023