Principal Process Engineer, Drug Product
This position is responsible for developing and supporting drug product manufacturing, packaging and serialization processes for pharmaceuticals and biologics. The individual will work with internal and external resources for the development of these processes and their transfer to clinical and commercial stage manufacturing and packaging plants.
Good things are happening at Omeros!
Come join our Omeros CMC Team!
Who is Omeros?
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?
- Managing technical relationships with contract packaging and contract manufacturing organizations (CPOs/CMOs) responsible for manufacturing GMP formulation and drug product unit processes including labeling, packaging and serialization for Omeros
- Developing and validating drug product manufacturing and packaging processes
- Responsible for supporting CMC aspects of the Company’s drug products from development through and including manufacturing and packaging
- Tech transfer of drug product manufacturing and packaging processes to CMOs and/or from CMO to another CMO
- Troubleshooting drug product manufacturing, packaging processes and equipment challenges; performing process related complex investigations
- Act as Person in Plant (PIP) to oversee process development and manufacturing activities at CMOs and CPOs (~20% of the time)
- Leading packaging and serialization aspects of late stage and commercial products
- Author drug product related regulatory reports and submissions
- Performing trending and monitoring of Critical Quality Attributes (CQAs) and In-Process Controls (IPCs)
- Ensuring compliance with all applicable regulatory guidelines
Education, Experience, Skills, and Knowledge Required:
- BS, MS or PhD degree in Chemical Engineering or a related field or equivalent professional experience
- A minimum of 8 years of biotechnology and/or pharmaceutical industry experience is required with a BS degree or 4+ years with a MS degree and 2+ years with a PhD degree
- Experience authoring CMC sections of regulatory submissions and participation in discussions with regulatory agencies is preferred
- Experience and knowledge with cGMPs and validation practices
- Experience with at least one biotechnology and/or pharmaceutical product launch is highly desirable
- Experience supporting regulatory inspections and external parties desired
- Demonstrated knowledge of drug product manufacturing
- Ability to navigate global regulatory CMC documents
- Demonstrated problem solving capabilities including strong analytical skills
- Possesses strong written and verbal communication skills, leadership, planning, and organizational skills
- Demonstrated ability to work in a team environment
- Attention to detail
- Proficient with Microsoft Office
Behavioral Competencies Required:
- Demonstrated ability to build and maintain positive relationships with management, peers, and subordinates
- Ability to influence at all levels
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
- May encounter prolonged periods of sitting or standing
- This position requires working around hazardous materials
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