Associate Director, CMC Project Management

Employer
Lundbeck
Location
Bothell, WA, United States
Posted
Nov 20, 2020
Ref
1471
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
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.

The Associate Director, CMC Project Management works closely with Lundbeck CMC Working Group and Focus Team Leaders to guide the development and implementation of strategic and tactical plans that support advancement of development programs successfully through commercialization, in alignment with Lundbeck goals and expectations.

ESSENTIAL FUNCTIONS:
  • Collaborates with CMC Working Group and Focus Team leaders to set priorities, agendas, plan activities and facilitate decision-making
  • Regularly meets with management to review recent results, set next plans, and ensure appropriate progress is being made on assigned programs.
  • Drives and facilitates timely & productive team discussions
  • Documents project progress by capturing key discussions, communications and decisions in meeting notes that are distributed and reviewed by the team on a regular basis. Establishes, maintains and is accountable for project timelines and associated CMC plans
  • Identifies critical issues and works with the applicable Team(s) to develop and implement appropriate mitigation plans
  • Ensures effective coordination of activities and/or deliverables across CMC functions
  • Anticipates obstacles or risks to development plans and to develop, prioritize and implement appropriate mitigation strategies
  • Identifies and escalates issues when programs or projects timelines and deliverables are at risk
  • Manages CMO contracts, resources and budgets
  • Serves as the primary point of contact for Lundbeck CMO partners

REQUIRED EDUCATION, EXPERIENCE and SKILLS:
  • Accredited bachelors' degree with 10+ years' experience in Healthcare and/or Life Sciences sector
  • Proven track record of success in managing internal and external project teams that may include CMOs and other outside vendors
  • Direct, hands-on experience with late stage and/or commercial biologics or pharmaceutical products
  • Excellent verbal and written communication skills, detail-oriented personality, and ability to work productively in an interdisciplinary team environment
  • Commitment to operational excellence
  • Action orientation, strong sense of urgency to meet/exceed goals.
  • Strong negotiation skills
  • Strong interpersonal skills
  • Proficiency with Microsoft Office programs including: Word, Excel, Outlook, PowerPoint, Visio, and Project.


PREFERRED EDUCATION, EXPERIENCE AND SKILLS:
  • B.S. in Biology, Chemistry, Engineering or related field;
  • 5+ years' experience in Program/Project Management in a Biologics Development or Manufacturing environment


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


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.

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Lundbeck is a global pharmaceutical company specialized in brain diseases. For more than 70 years, we have been at the forefront of neuroscience research. We are tirelessly dedicated to restoring brain health, so every person can be their best.

Millions of people worldwide live with brain diseases, and far too many suffer due to inadequate treatment, discrimination, a reduced number of working days, early retirement, and other unnecessary consequences. Every day, we strive for improved treatment and a better life for people living with brain diseases - we call this Progress in Mind.

Read more at www.lundbeck.com/global/about-us/progress-in-mind

Our approximately 5,800 employees in more than 50 countries are engaged in the entire value chain throughout research, development, production, marketing, and sales. Our pipeline consists of several R&D programs, and our products are available in more than 100 countries. We have research centers in Denmark and the US, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17 billion in 2019 (EUR 2.3 billion; USD 2.6 billion).

For additional information, we encourage you to visit our corporate site www.lundbeck.com, and connect with us on Twitter at @Lundbeck and via LinkedIn.