Associate Director Quality Control

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 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.

 
ESSENTIAL FUNCTIONS

• 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.

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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.