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Associate Director Project and CMO Management

Employer
Lundbeck
Location
Bothell, Washington
Start date
Sep 14, 2022
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Job Details

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:

The Associate Director, Project and CMO Management is responsible for defining and managing strategic CMC Biologics projects that are critical to Lundbeck’s success.  This role collaborates with cross-functional leaders and teams both within Lundbeck and with our Contract Manufacturing partners to guide the development and implementation of strategic and tactical plans supporting advancement of CMC programs successfully from development through commercialization.  

 

ESSENTIAL FUNCTIONS:

  • Provide project and Contract Manufacturing Organization (CMO) management expertise for the delivery of key strategic initiatives, including:
  • Establish and manage project plan development and execution across the CMC organization and with Lundbeck CMO partners, ensuring expected timelines and milestones are met.
  • Collaborate with internal and external cross-functional teams including Manufacturing, Process Development, Analytical and Formulation Development, Quality Assurance, Quality Control, Validation and Regulatory
  • Proactively identify and communicate obstacles, risks, or critical issues to development plans; develop and implement appropriate mitigation strategies with key stakeholders within CMC Biologics management and teams.
  • May coordinate project efforts across multiple products within CMC Biologics
  • Lead Lundbeck CMC and external cross-functional teams to meet defined objectives.
  • Ensure effective coordination of activities and/or deliverables across CMC functions, including support of regulatory filings, and project and budget reviews.
  • Support and contribute to defining project management best practices and tools within the Lundbeck PMO/CMO organization.
  • Facilitating the collaboration between the CMC teams in Copenhagen and at Lundbeck Seattle Biopharmaceuticals 
  • Serve as a role model for effective and transparent communication with all levels across the company and aligning key stakeholders within and outside of the CMC function.

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited bachelor’s degree
  • 6+ years of experience in the pharmaceutical/biotech industry OR an accredited master's degree with 4+ years of experience in the pharmaceutical/biotech industry
  • Adept at managing multiple programs and priorities in a fast-paced, regulated environment.
  • Proven track record of success in leading and managing internal and external cross-functional project teams
  • Demonstrated ability to build relationships, establish trust, and influence without authority
  • Direct, hands-on experience with early stage, late stage and/or commercial biologics or pharmaceutical products
  • Broad understanding of CMC functional areas including the requirements for development, manufacturing and testing of biologics products
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work productively in an interdisciplinary team environment
  • Proficiency with Microsoft Office programs including: Word, Excel, Outlook, PowerPoint, Visio, and Project.
  • 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:

  • M.S. or Ph.D in Biology, Chemistry, Engineering or related field;
  • Experience with Agile Project Management methodologies
  • Experience in Program/Project Management in a Biologics Development or Manufacturing environment.
  • Demonstrated ability to manage complex projects in partnership with CMOs.
  • Experience with international collaboration

 

TRAVEL

  • Willingness/Ability to travel up to 20% domestically and internationally

#LI-LM1, #LI-Hybrid

 

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.


 

Company

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.

Offices in:

  • Deerfield, IL - Lundbeck US Home Office
  • LaJolla, CA - Lundbeck La Jolla Research Center, Inc.
  • Bothell, WA - Lundbeck Seattle BioPharmaceuticals, Inc

Diversity

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

Benefits

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 go to the webpage below. https://www.lundbeck.com/content/dam/lundbeck-com/americas/united-states/careers/2022_Lundbeck_Benefits_Summary.pdf

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).

Lundbeck

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.

Employee Satisfaction

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.

Employee

Our Beliefs

• 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

   

CONNECT

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Find Us
Website
Phone
224-507-1000
Location
6 Parkway North
Deerfield
Illinois
60015
United States
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