Senior Quality Assurance Specialist, Biologics Commercial Quality Operations
Company: Lundbeck
Location: Seattle
Posted on: August 6, 2022
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Job Description:
Job Description 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 an experienced and highly
motivated individual to join our Quality Operations team. The ideal
candidate has experience with quality systems related to change
controls, deviations, product complaints, Annual Product Review and
lot disposition and is adept at managing multiple priorities in a
fast-paced, regulated environment. This position requires an
experienced candidate able to communicate effectively with internal
personnel, Contract Manufacturing Organizations (CMOs) and Contract
Test Laboratories (CTLs) to mitigate potential quality issues. This
position will also partner with quality management to support
continuous improvements of quality systems in support of commercial
biologics products. ESSENTIAL FUNCTIONS: Serves as a primary
Quality point of contact for one or more of Lundbeck's Contract
Manufacturing Organizations (CMOs) and/or Contract Testing
Laboratories (CTLs) and for the Quality oversight in alignment with
regulatory GMP expectations and established Quality Agreements
Review and approve internal and external investigations, CAPAs,
deviations, validation protocols and reports, change controls and
vendor communications Support Lundbeck's Product Complaint
Investigations Support internal lot disposition activities Prepare
applicable quality metrics for Quality Management Review meetings
Manage the Annual Product Quality Review Process Collaborate with
internal cross-functional teams including Manufacturing, Quality
Control, Validation and Regulatory Support and contribute to
continuous improvements of the core quality systems Comply with all
company policies, procedures, work instructions and training
requirements REQUIRED EDUCATION, EXPERIENCE and SKILLS: Accredited
bachelor's degree with a minimum of 6 years of experience in the
pharmaceutical/biotech industry OR an accredited master's degree
with a minimum of 4 years of experience in the
pharmaceutical/biotech industry OR a combination of education and
of experience in the pharmaceutical/biotech industry totaling 10
years Strong understanding of multiple quality systems and adept at
managing multiple priorities in a fast-paced, regulated environment
Ability to communicate effectively with internal personnel and
Contract Manufacturing Organizations Excellent working knowledge of
cGMP requirements, FDA and ICH guidelines and industry best
practices for biologics and parenteral applications The successful
candidate will have excellent written and oral communication
skills, a flexible attitude with respect to work assignments, and
the ability to proactively handle multiple tasks simultaneously
Strong computer skills, particularly with SAP, Microsoft Office
Suite and Adobe Acrobat Team player with the ability to work
collaboratively with other functions to execute Quality System
requirements 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 bachelor's degree in Sciences / Life Sciences Experience
with commercial biologics manufacturing Experience working with
CMOs and/or CTLs TRAVEL Potential for travel to international CMOs
LI-LM1 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 .
Keywords: Lundbeck, Seattle , Senior Quality Assurance Specialist, Biologics Commercial Quality Operations, Other , Seattle, Washington
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