Sr Manager, Upstream Bioprocess Engineering (Cell Culture)
Sr. Manager, Upstream Bioprocess Engineering
We are seeking a Sr. Manager, Upstream Bioprocess Engineering to join our CMC group. In this role, you will be responsible for developing and supporting processes for the manufacture of protein-based therapeutics. You will lead tech transfer and scale-up activities, working 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 and be a part of our 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 .
Essential Duties & Responsibilities:
- Manage technical relationships with CMOs responsible for manufacturing GMP drug substance for Omeros
- Support CMC aspects of the Company’s drug substances from development through and including manufacturing
- Troubleshoot cell culture, fermentation, and harvest processes and equipment challenges
- Lead tech transfer and scale-up activities
- Work with CMOs to define and drive process development, process characterization, and process validation activities
- 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
Education, Experience, Skills, and Knowledge Required:
- BS or MS degree in Chemical Engineering or a related scientific field
- A minimum of 10 years of biotechnology and/or pharmaceutical industry experience
- Experience authoring CMC sections of regulatory submissions and participation in discussions with regulatory agencies preferred
- Experience with at least one biotechnology and/or pharmaceutical product launch is highly desirable
- Demonstrated knowledge of cell culture and harvest processing, tech transfer, and scale-up is required
- Ability to navigate global regulatory CMC documents required
- Participation in PAIs a plus
- Familiar with cGMPs and Validation practices
- Demonstrated problem solving capabilities and strong analytical skills
- Good organizational skills
- Demonstrated ability to work in a team environment
- Excellent written and verbal communication skills
Behavioral Competencies Required:
- The ability to build and maintain positive relationships with management, peers, subordinates, and external partners
- The ability to work well in a dynamic organization
- Capable of leading and coaching
- Overnight travel is required, up to 20% of the time; international travel may be required
- Aid in the supervision of activities at multiple CMOs
- Responsibilities may include planning, assigning, and directing work at CMOs and internally, and resolving problems that arise at CMOs
- May supervise and mentor other employees
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting, up to 20 lbs
- May encounter prolonged periods of sitting or standing
- 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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.