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Lundbeck Seattle BioPharmaceuticals
Senior Quality Control Specialist
Requisition ID: 1504
Location: Bothell, Washington
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with sites worldwide including in Bothell, Washington, Lundbeck is the only global biopharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized 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. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.
In October 2019, Lundbeck acquired Alder Biopharmaceuticals, now known as Lundbeck Seattle BioPharmaceuticals (Lu-SBP). The Lu-SBP site is responsible for antibody development and biologics manufacturing in collaboration with the global Lundbeck CMC Biologics organization.
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.
RESOURCES
APPLY:
Lundbeck Seattle BioPharmaceuticals
Reference Job Code: 1504
Lundbeck Seattle BioPharmaceuticals is an Equal Opportunity Employer
Submitted: 01/16/2021
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