Sr. Process Engineer, Drug Product

Omeros   •  

Seattle, WA

Industry: Pharmaceuticals & Biotech


5 - 7 years

Posted 50 days ago

This position is responsible for developing and supporting drug product manufacturing processes for protein-based therapeutics. The individual will work with internal and external resources for the development of these processes and their transfer to clinical and commercial stage manufacturing plants.

Who is Omeros?

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system.

The company's drug product OMIDRIA® (phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed in the U.S. 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 has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington's disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.

What are your job responsibilities?

  • Manage technical relationships with CMOs responsible for manufacturing GMP drug product for Omeros

  • Develop and scale up drug product manufacturing processes suitable for both clinical use and commercial sale

  • Responsible for supporting CMC aspects of the Company's drug products from development through and including manufacturing

  • Tech transfer of drug product manufacturing processes to CMOs

  • Troubleshoot drug product manufacturing process and equipment challenges

  • Act as Person in Plant (PIP) to oversee process development and manufacturing activities at CMOs (10-20% of time)

  • Author drug product related regulatory reports and submissions

  • Ensure compliance with all applicable regulatory guidelines

What education and experience do you need?

  • BS or MS degree in chemical engineering or a related field or equivalent professional experience

  • A minimum of 5 years of biotechnology and/or pharmaceutical industry experience. More experienced candidates are encouraged to apply

  • Demonstrated knowledge of drug product manufacturing required

  • Demonstrated problem solving capabilities

  • Ability to navigate global regulatory CMC documents required

  • Experience authoring CMC sections of regulatory submissions and participation in discussions with regulatory agencies preferred

  • Participation in PAIs a plus

  • Experience with cGMPs and Validation practices

  • Experience with at least one biotechnology and/or pharmaceutical product launch is highly desirable

  • Experience supporting regulatory inspections is desirable

  • Good communication, managerial, analytical, planning, and organizational skills a must

  • Demonstrated ability to work in a team environment

Behavioral Competencies:

  • Must have the ability to build and maintain positive relationships with management, peers, and subordinates

  • Excellent written and verbal skills required

  • Must have integrity

  • Must display strong analytical and problem-solving skills

  • Attention to detail required

Physical Demands

  • 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

  • Overnight travel, approximately 20% of the time, is required

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.