Mar 16, 2020

Associate Director, Validation MSAT

  • Lundbeck LLC
  • Bothell, WA, USA

Job Description

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 supporting the Drug Substance & Drug Product Validation efforts at Lundbeck Seattle Biopharmaceuticals; including process characterization, preparations for BLA filings, process validation and GMP support activities in collaboration with Process Development, MSAT and external Contract Manufacturing Organizations (CMO). This role supports late stage clinical development and commercialization efforts and calls for someone with a strong technical background and knowledge of GMP and ISO environments.

 

ESSENTIAL FUNCTIONS

  • Acts as technical lead, in collaboration with Contract Manufacturing Operations (CMO’s) for validation activities within sterile filling fill-finish and packaging operations.  Ensures validation documentation is in compliance with industry standards and regulatory requirements.
  • Leads the data analysis of process-related data statistics, identifies process deviations, assesses product impact, prepares technical reports and proposes process solutions and improvements.
  • Interface with Process Development and CMO sites for knowledge transfers and process data analysis & mapping in order to anticipate potential risks and opportunities for improvements.
  • Identifies and initiates process and procedural changes to improve process performance, robustness, productivity, safety, efficiency and compliance.
  • Leads validation activities supporting manufacturing biologically derived therapeutic candidate molecules (mAbs, bi specifics, etc.) in collaboration with Process Development, MSAT, QA/QC, Regulatory and external CMO partners.
  • Serves as the as the validation subject matter expert (SME) relating to technology transfers, manufacturing operations, complex deviations, technical troubleshooting, CAPA design and implementation, process monitoring, change control and process optimization
  • Partners with other functions including Process Development, MSAT, QA/QC and Regulatory to ensure scale-down/up and characterization of manufacturing processes are robust and scientifically sound.
  • Collaborates with Process Development, Process Engineering in-house SME’s and external CMO’s to author validation master plan, and process characterization protocols and reports.
  • Participates in the Risk Management process utilizing and understanding the FMEA risk assessment tools.
  • Provides input and guidance for root cause investigations of process related deviations in a timely, comprehensive and conclusive manner. 

 

REQUIRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited BA/BS Degree and 10+ years in Biotechnology or Pharmaceutical Development,  an Accredited Master's degree and 8+ years in Biotechnology or Pharmaceutical Development, a PhD and 5+ years in Biotechnology or Pharmaceutical Development  or the equivalent combination of education and experience totally a minimum of 14 years. 
  • Minimum 3 years of direct experience with Validation.
  • A good understanding of statistical analysis and continuous process verification
  • The ability to work effectively in small matrix teams in a fast-paced environment with changing priorities and a high level of urgency.
  • Highly motivated with the ability to work independently as well as on cross-functional and cross-site teams.
  • Able to effectively establish and maintain productive relationships with internal colleagues and external stakeholders.
  • Excellent working knowledge of cGMP requirements, FDA /EMA regulations and ICH guidelines.
  • Excellent written and oral communication skills and the ability to proactively handle multiple tasks simultaneously.
  • Strong analytical and problem-solving skills.

 

PREFERRED EDUCATION, EXPERIENCE and SKILLS

  • Accredited BA/BS in Life Sciences
  • Ph.D. or Masters
  • Experience working with Contract Manufacturing Organizations

 

 TRAVEL

  • Willingness/Ability to travel up to 10% domestically and internationally 

 

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employement 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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