Senior Director Drug Product and Formulation Development

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.   

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.