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Senior Director Drug Product and Formulation Development

 
Requisition ID:  1486
Location: 

Bothell, Washington, US

Date:  Dec 30, 2020
 

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 Late-Stage Development and Production groups. 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.
 
At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen, Denmark, and with sites in more than 50 countries, Lundbeck is the only global biopharmaceutical company focused solely on treating brain diseases. Our legacy in neuroscience and heritage of innovation spans more than seven decades and has resulted in the discovery, development and commercialization of 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.
 

SUMMARY:
Responsible for leading Formulation Development, Drug Product development, Technology Transfer and Clinical Manufacturing Oversight for biologically derived therapeutics at Lundbeck under cGLP and cGMP guidelines.


ESSENTIAL FUNCTIONS:

  • Leads the development of stable formulations (liquid and/or lyophilized) for antibodies. 
  • Oversees the preparation of technical reports, data summaries and CMC related documents required for various regulatory submissions. 
  • Oversees the development of technical transfer protocols and supervises the development and transfer of drug product manufacturing processes into cGMP drug product manufacturing facilities. 
  • Participates in vendor selection process supporting Drug Product Manufacturing at CMOs for clinical and commercial programs.
  • Responsible for the technical management of third-party drug product manufacturers.
  • Provides technical oversight for clinical manufacturing activities.
  • Provide technical support for commercial manufacturing activities.
  • Work closely with Analytical, Bioassay, QC and QA partners to assess product quality and product stability. 
  • Represent the Drug Product group on CMC Focus Teams and Working Groups
  • Provide organizational leadership in all areas related to formulation, fill & finish work 
  • Work collaboratively and cross-functionally with other key leaders to execute on organizational goals. 
  • Assign resources according to priority and project needs. 
  • Represent the Drug Product group to senior management and All Hands Meetings on a regular basis. 

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor’s degree and 15+ years of experience in the biopharma industry OR Accredited Master’s degree with 12+ years of experience in the biopharma industry OR PhD with 10+ years of experience in the biopharma industry
  • Extensive prior experience in the process development and clinical or commercial cGMP production of antibody or antibody-related products. 
  • Extensive experience with formulation development for liquid, frozen and lyophilized drug products and intermediates, from study design to analytical evaluation. 
  • Strong familiarity of the collection of analytical techniques that support the formulation, fill/finish process development work. 
  • Experience supporting Fill-Finish Process Development, technology transfer and manufacturing oversight of Drug Product CMO partners
  • Excellent written and oral communication, including experience delivering professional internal and external presentations.
  • Demonstrated experience authoring protocols, reports and regulatory filings. 
  • Fluency in the regulatory guidance documents that touch upon drug product fill/finish and stability requirements. 
  • Strong working knowledge of cGMPs and compliance requirements. 
  • Prior experience interacting with the FDA during inspections. 

 

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • PhD in biology or chemistry-related disciplines and 10+ years industry experience
  • Experience with Pre-Filled Syringe and Autoinjector development is strongly desired

 

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. 

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.