We are a growing and dynamic organization seeking a Process Engineer, Upstream to join our CMC organization. This position is responsible for developing and supporting processes for the manufacture of 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.
Good things are happening at Omeros!
Come join our Omeros 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 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?
Your responsibilities in this position will include:
Manage technical relationships with CMOs responsible for manufacturing GMP drug substance for Omeros
Develop and scale up cell culture manufacturing processes suitable for both clinical use and commercial sale
Responsible for supporting CMC aspects of the Company's drug substances from development through and including manufacturing
Tech transfer of manufacturing processes to CMOs
Troubleshoot cell culture, fermentation, and/or purification 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 substance related regulatory reports and submissions
Ensure compliance with all applicable regulatory guidelines
What knowledge and skills does our ideal candidate have?
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
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 cell culture protein processing 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
Supervisory Responsibilities will include:
Will aid in the supervision of activities at multiple CMOs. Responsibilities may include planning, assigning, and directing work at CMOs; and resolving problems that arise at CMOs
Overnight travel, approximately 20% of the time, is 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
If you have the experience, skills and knowledge we are seeking, we'd love to hear from you! This is an exciting opportunity for the right person!
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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.
Posting ID: 556238094Posted: 2020-08-09