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Principal Research Associate, Analytical Development

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Dec 4, 2022

View more

Discipline
Information Technology, Business/Data Analytics, Regulatory
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioForest

Job Details

 

Principal Research Associate, Analytical Development

 

 

This position will support clinical development and commercialization of antibody therapeutics. The Principal Associate will bring a strong technical background including development, transfer, and qualification of analytical methods, characterizing physicochemical attributes of therapeutic candidates, developing new and orthogonal methods for extended characterization, and evaluating orthogonal and complimentary technologies to improve throughput. This position will also contribute to tech transfer to clinical and commercial stage CRO’s/CMO’s.  

 

Good things are happening at Omeros!

 

Come join our Omeros CMC 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.

 

What are your job responsibilities?

 

  • Focus on method development and characterization in support of early and late-stage clinical development and commercilization of protein therapeutics (drug substance and drug product)
  • Analytical method development, testing, transfer, qualification, and validation
  • Troubleshoot typical method and equipment challenges
  • Write standard test methods, technical reports summarizing analytical data, and qualification / validation reports
  • Participate in cross-functional teams as a representative of the Analytical Development group
  • Assists in trouble-shooting CMC-related problems from CROs / CMOs
  • Assists in investigations involving data generated internally and by CROs / CMOs
  • Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with relevant regulations.
  • Contribute to drafting regulatory submissions
  • Ensures compliance with all applicable regulatory guidelines

 

Education, Skills and Knowledge:

 

  • BS or MS degree in Chemistry, Biochemistry, Biology, Analytical Chemistry, or a related field with 7+ years of biotechnology and/or pharmaceutical industry experience.
  • Experience developing robust HPLC (SEC, RP, peptide map, CEX, etc.) and/or CE-based (CE-SDS, cIEF, icIEF) methods
  • Experience with troubleshooting and optimizing methods
  • Experience with routine lab equipment and methods, including preparing buffers, measuring pH, UV absorbance, quantifying particulates, etc.
  • Experience and proficiency with Waters Empower and/or Sciex 32 Karat software is highly desired
  • Experience with technology transfer to third parties is desired
  • Strong understanding of technical principles of chromatographic and/or electrophoretic methods
  • Demonstrated analytical, problem solving and multi-tasking capabilities
  • Capable of interpreting data and communicating and presenting results to peers and management
  • Demonstrated written and verbal communication skills with peers and management
  • Detail oriented, proactive, and self-motivated

 

Behavioral Competencies Required: 

 

  • Demonstrated ability to build and maintain positive and collaborative relationships with management and peers 

 

Physical Demands Required:

 

  • Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
  • May encounter prolonged periods of sitting
  • This position requires working with and near hazardous material

 

Compensation and Benefits

 

Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for this position is $90,000 to $105,000 per year.  Salaries will be determined based on knowledge, skills, education and experience relevant to the role.  Employees are offered medical, dental, vision and life insurance and a 401k plan with a company match.  Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year.  This position is eligible for bonus and stock options. To learn more about Omeros, please visit www.omeros.com. 

 

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.

Company info
Website
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
Washington
98119
US

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