Sr Process Engineer, Upstream (Biologics)

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?

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

Education, Experience, Skills, And Knowledge Required

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

Behavioral Competencies Required

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

Travel Requirements

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

Physical Demands Required

• May encounter prolonged periods of sitting
• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
• 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 ten 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 [email protected] or contact Omeros, asking for Human Resources, at (206) 676-5000.