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Sr Process Engineer, Upstream (Biologics)

Employer
Omeros Corporation
Location
Seattle, WA
Start date
Jan 24, 2023

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Job Details

Sr. Process Engineer - Upstream (Biologics)

 

 

This position is responsible for developing and supporting processes for the manufacture of protein-based therapeutics. As a Sr. Process Engineer, you will work with internal and external resources for the development of these processes and their transfer to clinical and commercial stage manufacturing plants.

 

Good things are happening at Omeros!

 

Come join our Omeros CMC Team!

 

About Omeros Corporation

 

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?

 

  • Managing technical relationships with CMOs
  • responsible for manufacturing GMP drug substance for Omeros
  • Developing and scaling up cell culture manufacturing processes suitable for both clinical use and commercial sale
  • Supporting CMC aspects of the Company’s drug substances from development through and including manufacturing
  • Tech transfer of manufacturing processes to CMOs
  • Troubleshooting cell culture, fermentation, and/or purification process and equipment challenges
  • Acts as Person in Plant (PIP) overseeing process development and manufacturing activities at CMOs (10-20% of time)
  • Author drug substance related regulatory reports and submissions
  • Ensuring compliance with all applicable regulatory guidelines

 

Education, Experience, Skills, and Knowledge Required:

 

  • BS or MS degree in Chemical Engineering or a related field or equivalent professional experience
  • A minimum of 8+ years of biotechnology and/or pharmaceutical industry experience
  • Experience authoring CMC sections of regulatory submissions and participation in discussions with regulatory agencies
  • Experience with cGMPs and Validation practices
  • Experience with at least one biotechnology and/or pharmaceutical product launch
  • Experience supporting regulatory inspections
  • Demonstrated knowledge of cell culture protein processing
  • Participation in PAIs
  • Ability to navigate global regulatory CMC documents
  • Good communication, managerial, analytical, planning, and organizational skills
  • Strong analytical and problem-solving skills; demonstrated problem solving capabilities
  • Attention to detail

 

Behavioral Competencies Required: 

 

  • The ability to build and maintain positive relationships with management, peers, and subordinates
  • Demonstrated ability to work in a team environment
  • Integrity

 

Travel Requirements:

 

  • Ability to travel 10% of the time with occasional overnight travel required

 

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 $120,000 to $150,000 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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