Manager, Process Engineering - Downstream (Biologics)
Good things are happening at Omeros!
Come join our CMC Omeros Team!
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.
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?
- Manage technical relationships with CMOs responsible for manufacturing GMP drug substance for Omeros
- Responsible for supporting CMC aspects of the Company’s drug substances from development through and including manufacturing
- 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 reports and CMC sections of regulatory 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 scientific field
- A minimum of 10 years of biotechnology and/or pharmaceutical industry experience
- Demonstrated knowledge of cell culture and downstream 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
- Familiar with cGMPs and Validation practices
- Experience with at least one biotechnology and/or pharmaceutical product launch is highly desirable
- Good organizational skills
- Demonstrated ability to work in a team environment
- Excellent written and verbal skills
Behavioral Competencies Required:
- The ability to build and maintain positive relationships with management, peers, and subordinates
- Displays strong analytical and problem-solving skills
- The employee is required to travel overnight, up to 20% of the time
- 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
- May supervise lower level employees
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting, up to 20 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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.