Lundbeck Associate Director Process and Drug Product Development in Bothell, Washington
Associate Director Process and Drug Product Development
Requisition ID: 2671
Bothell, Washington, US
Date: Jan 14, 2022
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!
Responsible for the ongoing leadership of a lean and effective Drug Product Technology function at Lundbeck that will play a key role in developing technologies for large scale drug product manufacture of antibody and antibody-based therapeutics. In collaboration with team members in Analytical, Quality and Drug Substance groups, the Director, Drug Product Technology will ensure that our drug product production process is robust, scalable, well characterized and economical.
Guide the development, scale-up and production of drug product presentations for use by physicians and patients.
Collaborate with Lundbeck’s network of contract manufacturers on technology transfer, process improvements and troubleshooting equipment and operational issues.
Strengthen the technical capacity for drug product process development and improve in-house expertise and laboratory capacity
Facilitate growth of the department, such as incorporate new technologies and establish best practices
Initiate and support technical transfer and manufacturing activities at fill finish CMOs. Establish and maintain excellent working relationship with internal and external partners to deliver successful manufacturing processes
Be responsible for reviewing and authoring of drug product sections of regulatory submissions. Serve as SME and provide strategy guidance for key regulatory interactions
REQUIRED EDUCATION, EXPERIENCE AND SKILLS
Accredited Master’s degree
8+ years of biological or/and small molecule pharmaceutical development experience
Proven success in process scale-up and manufacturing support, familiarity with current Good Manufacturing Practices and US/EU regulations, cGCP (FDA, ICH, and ISO) requirements and regulatory guidelines as well as advanced practical and theoretical knowledge of common industry drug product process unit operations
Capable of highly collaborative approach and proven ability to work in a fast paced, team-oriented environment
Proven success in demonstrating flexibility, independence, and ability to prioritize and manage multiple tasks simultaneously in a changing environment.
Outstanding interpersonal and communication (written and verbal) skills; proficient with computer and standard software programs
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 Master’s degree in Chemical, Biochemical Engineering or comparable field OR Ph.D. in Chemical or Biochemical Engineering or in comparable field
4+ years of supervisory or leadership experience
Experience working with CRO and CMO
Experience in working with products for intravenous and subcutaneous routes of administration
Working knowledge of aseptic processing and experience in technology for parenteral drug product manufacturing
Working knowledge of Quality by Design and Design of Experiment principles
Understanding of critical quality attributes and analytical characterization of biopharmaceutical drug product
Strong analytical skills, problem-solving ability, and presentation skills required.
- Domestic travel up to 10%. International travel may be required.
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 theU.S. career site (https://lundbeck.com/upload/us/careers/2021_Lundbeck_Benefits_Summary.pdf) .
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 theU.S. career site (https://www.lundbeck.com/us/careers/eeo-accommodations-policy) .
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 inE-Verify (https://e-verify.uscis.gov/web/media/resourcesContents/E-Verify_Participation_Poster.pdf) .
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.
Billions of people worldwide live with brain diseases – complex conditions often invisible to others that nonetheless take a tremendous toll on individuals, families and societies. We are committed to fighting stigma and discrimination against people living with brain diseases and advocating for broader social acceptance of people with brain health conditions. Every day, we strive for improved treatment and a better life for people living with brain disease.
We have approximately 5,600 employees in more than 50 countries, and our products are available in more than 100 countries. Our research programs tackle some of the most complex challenges in neuroscience, and our pipeline is focused on bringing forward transformative treatments for which there are few, if any therapeutic options. We have research facilities in Denmark and the United States, and our production facilities are located in Denmark, France, and Italy. Lundbeck generated revenue of DKK 17.7 billion in 2020 (EUR 2.4 billion; USD 2.7 billion).
For additional information, we encourage you to visit our corporate site www.lundbeck.com and connect with us on Instagram (h_lundbeck), Twitter at @Lundbeck and via LinkedIn.
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