Associate Director Process and Drug Product Development

Employer
Lundbeck
Location
Bothell, Washington
Posted
May 05, 2022
Ref
2671
Hotbed
BioForest
Required Education
Doctorate/PHD/MD
Position Type
Contract

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
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.  
 
ESSENTIAL FUNCTIONS

  • 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
  • Support budgeting

 
REQUIRED EDUCATION, EXPERIENCE AND SKILLS

  • PhD with 6+ years of biological or/and small molecule pharmaceutical development experience or an Accredited Master’s degree with 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.
     

TRAVEL

  • Domestic travel up to 10%.  International travel may be required.

#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.