Senior Scientist/Associate Director, DMPK (Biologics)
Who is Omeros? Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies, and disorders of the central nervous system.
Derived from its proprietary PharmacoSurgery® platform, the company’s first drug product, Omidria® (phenylephrine and ketorolac injection) 1%/0.3%, has been approved by the FDA for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission (EC) has approved Omidria® for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has five clinical-stage development programs focused on: complement-related thrombotic microangiopathies; Huntington’s disease, schizophrenia, and cognitive impairment; addictive and compulsive disorders; and preventing problems associated with urologic surgical procedures. In addition, Omeros has a proprietary GPCR platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development.
BE A PART OF OMEROS - COME LEAD DMPK EFFORTS TO CHRACTERIZE BIOLOGIC DRUG CANDIDATES!
What will your responsibilities be? You will serve as the subject matter expert for pharmacokinetics and bioanalytical assays for monoclonal antibodies and other protein therapeutics from late stage research through clinical development, and will also be assisting in the characterization of small molecule therapeutics. As our ideal candidate, you will have demonstrated experience in pharmacokinetic modeling and simulation supporting preclinical and clinical dose selection. You will have responsibilities for designing and assessing in vitro biotransformation and in vivo metabolism studies and you’ll serve on cross-functional project teams as the DMPK-BA representative.
This will include:
- Serving as a subject matter expert and DMPK-BA representative on project teams supporting the development of novel biologic and small molecule therapeutics in multiple therapeutic areas.
- Showing a thorough understanding of ADME characterization of antibodies, fusion proteins, biospecifics, and/or antibody drug conjugates, and understanding applicability of these attributes to candidate selection for clinical development while having a deep understanding of international regulatory guidance pertaining to those activities.
- Leading efforts to develop quantitative assays by ELISA/MSD/Ligand Binding Assays or HPLC-MS/MS for quantitation and pharmacodynamics activity of various molecules in biological matrices.
- Designing, analyzing and interpreting in vitro and in vivo DMPK studies and assays, including use of PBPK modelling techniques to guide investigational approaches.
- Contributing to the preparation of study protocols and reports for worldwide regulatory submissions.
- Serving as a liaison with the small and large molecule bioanalytical groups to ensure reagent generation, method development and sample analysis timelines are met.
- Training and coaching associate DMPK Scientists.
What does our ideal candidate look like?
As our ideal candidate, you’ll have a PhD in Pharmacokinetics, Pharmaceutics, Life Sciences or a related field with 3-8 years of relevant experience in the pharmaceutical industry or contract research organizations.
You’ll possess a strong knowledge of pharmacokinetic/pharmacodynamic analysis, demonstrated experience in modeling and simulation in a structured environment within the pharmaceutical industry and a thorough understanding of the regulatory guidelines and current knowledge of trends in pharmacokinetics.
Along with proficiency in Phoenix/WinNonlin, NONMEM or similar modeling software, you’ll need to have strong bioanalytical method development skills on multiple technology platforms such as MSD, ELISA, and LC/MS/MS.
Additionally, you’ll have previous experience in representing DMPK-BA on project teams, using your ability to influence, negotiate and communicate with both internal and external stakeholders and your ability to successfully work with a collaborative, fast-paced project team. Excellent organizational skills, quality and time-line focused, and the ability to rapidly adapt to changing priorities rounds out the skills we are seeking in our ideal candidate.
In this role, you’ll have the opportunity to not only lead efforts to characterize biologic drug candidates but to act as a subject matter expert and representative on project teams playing a pivotal role in the Company’s development projects. If you have the skills and experience we are looking for, want to join a growing and exciting organization where you will have the opportunity to play an integral role, we’d like to hear from you. Reference position OMS-2016-007 and send your cover letter and resume to email@example.com.
Reference Job Code: OMS-2016-007
Omeros Corporation is an Equal Opportunity Employer