Manager, Bioprocess Engineering - Seattle, WA | Biospace
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Manager, Bioprocess Engineering

Omeros Corporation

Location:
Seattle, WA
Posted Date:
7/24/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Chemical Engineering, Chemistry, Engineering, Manager, Pharmaceutical, Process Engineer,

Job Description

Omeros is seeking a Bioprocess Engineering Manager who will be responsible for developing and supporting processes for the manufacture of protein-based therapeutics. Reporting to the Director, you’ll have the opportunity to 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 CMC Group!

Who is Omeros?

Omeros is a Seattle-based biopharmaceutical company committed to discovering, developing, and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system.

Part of its proprietary PharmacoSurgery® platform, the company's first drug product, OMIDRIA® (phenylephrine and ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in April 2015. OMIDRIA is the first and only FDA-approved drug (1) 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 and (2) that contains an NSAID for intraocular use. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and lens replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.

Omeros has 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 proprietary G protein-coupled receptor, or GPCR, platform, which is making available an unprecedented number of new GPCR drug targets and corresponding compounds to the pharmaceutical industry for drug development, and a platform used to generate antibodies.

What are your job responsibilities?

•   Supporting CMC aspects of the Company’s drug substances from development through, and including, manufacturing

•   Troubleshooting cell culture, fermentation, and/or purification process and equipment challenges

•   Acting as the Person in the Plan (PIP) to oversee process development and manufacturing activities at US and International CMO’s (10-20% of the time)

•   Assessing processing at lab scale

•   Authoring drug substance related reports and CMC sections of regulatory submissions

•   Ensuring compliance with all applicable regulatory guidelines

Requirements

What experience and education do you need?

You’ll need a BS or MS degree in Chemical Engineering or a related scientific field and a minimum of 5 years of biotechnology and/or pharmaceutical industry experience.

Additionally, we are seeking candidates with the following experience:

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

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

•   Experience participating in PAIs

What knowledge and skills does our ideal candidate have?

To be successful in this role, our ideal candidate will have the following knowledge and skills:
•   Demonstrated knowledge of cell culture and upstream and/or downstream protein processing

•   The ability to navigate global regulatory CMC documents   

•   Familiarity with cGMPs and Validation practices

•   Demonstrated ability to work in a matrixed team environment as well as the ability to build and maintain positive relationships with management, peers, and subordinates

•   Effective managerial/leadership, strong problem-solving and analytical skills, and demonstrated planning, and organizational skills

•   Excellent written and verbal skills

What else do you need to know?

You’ll be required to travel overnight, both nationally and internationally, up to 20% of the time.

If you have the skills, knowledge and experience we are looking for, are looking for growth as well as a position where you can make an impact, we’d love to hear from you!

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.