CMC Project Manager
CMC Project Manager
This position is primarily responsible for providing project management support to CMC teams, tracking action items and core deliverables, creating project plans, managing meetings, and coordination of efforts cross-functionally to meet all program needs.
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?
- Manages 2 – 4 CMC project teams and/or working groups
- Develops project plans with minimal support from others and works closely with project leads and/or department head
- Tracks action items, core CMC deliverables and decisions using PM tools. Interactions include internal and external CMC work teams
- Supports CMC project lead/department head with the optimization of CMC project deliverables (schedules, resources, budgets)
- Develops an awareness of project management strategies and aligns projects with emerging strategies, methods, and processes
Education, Experience, Skills, and Knowledge Required:
- Bachelor’s degree or higher in Biology or Chemistry (Sciences preferred)
- 3-9 years of directly relevant professional experience, dependent upon the level, or education equivalent (Project Management, CMC and/or CMO/CRO management)
- Project Management Professional (PMP) Certification preferred
- Understanding of GMPs, GLPs and Biopharmaceutical Product Development
- Understanding of standard CMC contract management
- Highly detail-oriented, well-organized, and able to prioritize multiple tasks to meet deadlines
- Must display strong analytical and problem‑solving skills
- Clear written and verbal communication skills, comfortable discussing risks and constraints that could impact project success
- Proficient in Microsoft Office, MS Project, general project management tools
Behavioral Competencies Required:
- Effectively manages team meetings and facilitates discussion and decisions
- Ability to moderate complex and/or contentious discussions
- Must have the ability to build and maintain positive relationships with management, peers, and external clients
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 around hazardous materials located within the building
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.