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Associate Director, Nonclinical PK and Biological Analysis

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Sep 3, 2022

View more

Discipline
Science/R&D, Bioanalytical Services, Pharmacokinetics
Required Education
Bachelors Degree
Position Type
Contract
Hotbed
BioForest
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Job Details

Associate Director, Nonclinical Pharmacokinetics & Bioanalytical Analysis

 

In this position you will be responsible for developing and validating bioanalytical methods to support GXP pharmacokinetic and pharmacodynamic assessments for large molecule drug development candidates. You will be proficient with pharmacokinetic and pharmacodynamic modeling for nonclinical animal studies and biomarker research.  This position also includes responsibilities as a BA-DMPK scientific project team representative, potential management of associate scientific staff, and will give you an opportunity to collaborate extensively with Clinical and Research department projects.

 

 

Good things are happening at Omeros!

 

Come and be a part of our Nonclinical Team!

 

 

Who is Omeros?

Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit   www.omeros.com.

 

Essential Duties & Responsibilities: 

  • Serves as a BA-DMPK representative on project teams supporting the discovery and development of novel antibody and protein therapeutics areas across various therapeutic indications
  • Serves as the nonclinical pharmacokinetics and pharmacodynamics subject matter expert in project teams
  • Contributes to characterization and selection of protein therapeutic drug candidates
  • Develops and implements bioanalytical assays (e.g., ELISA and MSD) for the quantitation of drug candidates and biomarkers in biological matrices in-house
  • Manages the transfer and validation of ligand binding assays at contract laboratories to support GXP-compliant studies
  • Leads the design, analysis and interpretation of in vitro and in vivo DMPK assays and studies with biologic drug candidates
  • Contributes to the preparation of study protocols and reports for regulatory submissions
  • Serves as primary author of nonclinical pharmacokinetics sections of US and international regulatory dossiers (e.g., IND, IB, BLA)
  • Serves as a liaison with the small and large molecule bioanalytical group to ensure reagent generation, method development and sample analysis timelines are met
  • Trains, supervises, and mentors associate bioanalytical DMPK scientists

 

Education, Experience, Skills, and Knowledge Required:

  • Ph.D. in Pharmaceutical, Life Sciences or related field with 5-10 years of relevant experience in the pharmaceutical, biotechnology industry or contract research organization
  • Expertise with PK/PD analysis of biologics is required
  • Experience with biologics PK/PD modeling and developing ligand binding assays for measuring biologic molecules and/or biomarkers in preclinical study samples is essential; protein biochemistry experience is a plus
  • Experience in representing BA-DMPK on project teams is advantageous
  • Familiarity with the selection, characterization, and qualification of antibodies, fusion proteins, and biospecific therapeutics
  • Strong bioanalytical method development skills on multiple technology platforms such as ELISA, MSD, and LC-MS/MS)
  • High level of scientific integrity and understanding of current best practices for assay validation using current regulatory guidance documents
  • Proficiency with Phoenix/WinNonlin, NONMEM or similar modeling software
  • Aptitude with Microsoft Office applications is essential

 

Behavioral Competencies Required: 

  • Ability to influence, negotiate and communicate with both internal and external stake holders
  • Ability to work well in a collaborative, fast-paced, project team environment

 

If you have the experience, skills and knowledge we are seeking, we’d love to hear from you! This is an exciting opportunity for the right person!

 

Omeros is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status such as race, religion, color, national origin, sex, age, marital status, or any other factor determined to be unlawful by federal, state, or local statutes.

 

It is our policy to provide reasonable accommodation to anyone with a disability who needs assistance completing the job application process. If you need assistance, you can either send an e-mail to  hr@omeros.com  or contact Omeros, asking for Human Resources, at (206) 676-5000.

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Find Us
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
98119
US
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