Position Description

Sr Process Engineer, Upstream (Biologics)
Location Corporate Office
# of openings 1
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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!

 

Who is Omeros? 

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros’ proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.

 

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

 

 

 

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.

 

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