Associate Director Quality Control
- Bothell, Washington
- Start date
- Feb 28, 2023
- Quality, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
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!
Lundbeck Seattle BioPharmaceuticals is seeking an Associate Director, Quality Control to lead the Development Quality Control team within Lundbeck’s CMC Biologics organization. Primary responsibilities include managing all QC deliverables to support the biologics development pipeline with projects spanning from pre-IND through marketing application. The Associate Director will have responsibility for independently managing all QC staff, execution of project and organizational goals and oversight of outsourced GMP work including method validation, lot release and stability testing.
- Manage QC staff including recruiting, onboarding, and performance management
- Focus on employee engagement by creating a culture of transparent communication, teamwork, and empowerment with a strong focus on career development for QC staff
- Develop short-term and long-term goals for QC team in alignment with project goals and broader organizational goals; monitor progress against goals
- Provide input on budget and resources
- Ensure all project team deliverables are met for outsourced QC work including lot release, stability testing, method validation/transfer/verification, reference standard qualification and analytical comparability
- Continue to build a strong interface to Analytical Development to ensure seamless transfer of analytical methods into QC labs and subsequent phase appropriate validation of such methods
- Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including development (upstream, downstream and formulation), CMO and Project Management, Regulatory CMC, and Quality Assurance
- Independently resolve technical issues; effectively lead teams with internal and external SMEs to solve issues with broad scope and/or high complexity
- Escalate challenges to management; develop constructive proposals and implement solutions for resolution of challenges
- Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial and regulatory requirements
- Review and approve deviations, laboratory investigations and evaluate proposed analytical change requests
- Partner with Analytical Development to develop and execute analytical comparability protocols to support process changes
- Oversee QC contributions to regulatory flings including review of regulatory applications (clinical and marketing applications), review of responses to information requests, and review of briefing documents; develop and implement plans to address gaps based on regulatory feedback or country specific testing requirements
- Lead efforts to harmonize QC business processes and SOPs with other Lundbeck functional areas; ensure SOPs are compliant with applicable regulations while maintaining flexibility and being phase appropriate
REQUIRED EDUCATION, EXPERIENCE and SKILLS:
- Accredited Bachelor’s Degree in biochemistry, chemistry, analytical chemistry, biology, or related field
- 8+ years' experience in Quality Control or other related function within a biologics/pharmaceutical company
- 2+ years people management experience with proficiency in establishing objectives, monitoring performance, providing feedback, and developing staff
- Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH) as they relate to QC testing
- Experience reviewing analytical test results and solving technical problems associated with a wide variety of QC assays for biologic products including compendial methods, chromatography methods, plate-based methods, and microbiological methods
- Demonstrated expertise in analytical method lifecycle management including test method approval, method verification, method validation and method transfer
- Strong knowledge of GMP stability program including protocol design and shelf-life assignment
- Experience with specifications, lot release testing and COAs
- Experience with managing QC related deviations, change controls, and laboratory investigations
- Demonstrated proficiency with managing QC staff to ensure that project timelines and deliverables are met
- Ability to work cross-functionally with excellent verbal communication and collaboration skills
- Strong written communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
- Quality mindset with demonstrated ability to address compliance gaps
- 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:
- Advanced degree in biochemistry, chemistry, analytical chemistry, biology, or related field
- Experience with outsourcing of QC GMP testing to CMOs and contract labs including routine oversight, contract/quote review and issue resolution
- Experience with developing and managing budgets including resource planning
- Previous experience with writing CMC sections of regulatory submissions including Module 3 and Module 2.3, briefing documents, and responses to regulatory information responses
- Experience in multiple phases of drug development including early phase (pre-IND) through marketing application and commercialization; ability to apply phase appropriate requirements in alignment with applicable regulatory expectations
- Experience supporting global regulatory filings associated with marketing applications including understanding of global pharmacopeial requirements
- Ability to manage transition of development QC programs to separate commercial QC function
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: $155,000 - $195,000 and eligibility for a 18% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term incentive plan. 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.
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.
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., 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.
- Deerfield, IL - Lundbeck US Home Office
- LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
- Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc
Diversity matters, and inclusion creates powerful organizations To ensure that we reflect the diversity of our patients and their needs, we are focused on creating the context, culture, and systems where all Lundbeck employees - no matter who and where they are - can be their authentic self and perform at their best. In practice, this means that individuals feel empowered not despite their differences but because of them. We know that people are sometimes put into boxes - some of these boxes are of our own choosing and some of these boxes are chosen for us. For this reason, Lundbeck is taking a systematic, business-led approach to D&I that looks into and breaks down these boxes. Our bold action on inclusion includes an ambitious two-year plan that enables equality of opportunity through fairness and transparency, promotes openness, tackles bias and discrimination, and fosters belonging through our unique Lundbeck culture. From the highest levels of Lundbeck to the shop floor, we are working to ensure D&I is an integrated practice and mindset. "We win together. Lundbeck is a place where you grow and thrive – personally and professionally. We embrace the uniqueness of individuals, knowing we are stronger when every brain is in the game." Deborah Dunsire, CEO
Lundbeck offers a competitive benefits package that includes:
• Medical, dental, vision effective day 1 of employment
• Generous vacation, sick leave, holiday shut down and company paid holidays
• 401k match with immediate vesting
• Parental Leave
• Hybrid work model for office-based roles
To view more details about our Benefits, please click on the link below.
Lundbeck 2023 Benefits Summary
Sustainable Development Goals
In 2020, we based the key aspects of our sustainability strategy on the UN Sustainable Development Goals (SDGs). We found we have a significant impact on seven of the 17 Goals:
• Goal 3: Good Health and Well-being
• Goal 5: Gender Equality
• Goal 8: Decent Work and Economic Growth
• Goal 10: Reduced Inequalities
• Goal 12: Responsible Consumption and Production
• Goal 13: Climate Action
• Goal 16: Peace, Justice, and Strong Institutions
Key examples are Goal 3 that is closely linked to our corporate purpose and dedication to restore brain health and Goal 13 that drives our efforts to prepare for a zero emissions future. We will use our influence and act to promote Goals 5, 8, 12 and 16. Across our sustainability actions, we are seeking partnerships with others to enable change and maximize impact (Goal 17).
Who We Are
A highly specialized pharmaceutical company that has conducted neuroscience research for more than 70 years. We develop innovative treatments to restore brain health and transform the lives of millions of people worldwide.
What We Strive For
Global leadership in brain health. Whatever your area of specialization, you will be part of our company-wide commitment to develop and advance treatments that improve the lives of people with brain disease.
What Drives Us
A culture of innovation, collaboration, and respect. We inspire curiosity, expect integrity, and pursue our achievements through knowledge-sharing, patient engagement, and the passion to deliver our end goal.
Our Societal Commitment
We understand we carry a huge responsibility for the societies we serve, and use our knowledge and voice to raise awareness, challenge standards, and increase opportunities – for patients and each other. We are at the forefront of treatment innovation, and together we continue to make a difference to people living with brain diseases.
Our Investment in You
As one way we invest in your career, we offer our employees a competitive compensation and benefit package that matches benchmark and general market conditions in our individual business locations.
The success of our strategy, “Expand and Invest to Grow Lundbeck” hinges on our combined competencies – and competence hinges on highly qualified and motivated employees. Our Employee Satisfaction Survey (ESS) gives us the pulse on employee motivation by asking about key elements in our work lives including management, work climate and development opportunities. We follow up on the ESS with concrete initiatives aimed at maintaining our focus on our unique workplace culture and providing personalized and aligned development opportunities for our employees.
• Patient-driven We put patients at the center of our fight for health and human dignity.
• Courageous We dare to confront unsolved healthcare challenges.
• Ambitious We set high expectations for ourselves because people in need have high expectations of us.
• Passionate We persist in developing life-changing therapies because life should not be interrupted by brain disease.
• Responsible We act with respect and integrity in everything we do
6 Parkway North
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