Senior Clinical Supply Specialist
The Sr. Clinical Supply Specialist is responsible for many of the activities as they relate to the leadership and support of the Company’s Supply Chain for clinical trial materials (CTM). The individual will primarily work with Clinical Operations, QA/RA, and Clinical Data Management to address global CTM needs and will work independently and collaboratively with the cross functional team to execute the various duties associated with Clinical Supply ensuring on-time delivery of CTM to studies. This position will also ensure that all the data related to those efforts are managed appropriately.
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?
- Support tactical and day to day clinical supply chain activities with the larger objective of company goals in mind to optimize inventory, minimize costs, and help support Clinical Operation’s goals
- Work with and lead the interactions with external third-party vendors relating to clinical supply and drug product, as needed
- Establish long range/term strategic supply planning
- Coordinate activities related to packaging, labeling, distribution (global import/export, cold chain, etc.), and storage of CTMs on an as-needed basis and work with QA on ensuring batches are released
- Lead the return and/or destruction of expired drug from global clinical sites and depots
- Manage the IP accountability and inventory at external third-party vendors such as Packaging and Labeling sites
- Maintain all aspects of record keeping and data management, per assigned activities – offline and online
- Support the Supply Chain team on department strategy, budget reviews, and general activities
- Perform other duties and responsibilities, as required
Education, Experience, Skills, and Knowledge Required:
- Preference for science-based bachelor’s degree (or equivalent) with a minimum of 5 - 8 years related experience within clinical supply/clinical operations or equivalent combination of education and experience
- Proven interpersonal skills with the ability to work collaboratively as a member of a cross-functional team. Ability to establish and maintain effective working relationships
- Knowledge of applicable cGMP, cGCP and ICH Quality guidelines and global regulatory requirements preferred
- Knowledge of basic import and export distribution principles
- Experience with Interactive Response Technologies (IRT) and/or supply management systems preferred
- Expert knowledge of MS Office, and Excel,
- Excellent communication skills (written and verbal)
- Strong attention to detail and analytical, organizational, problem-solving skills
- Excellent customer-service orientation, a high degree of professionalism, and the ability to work with limited direction
- Self-motivated, with initiative and the ability to take ownership of, and follow through with specific tasks
Behavioral Competencies Required:
- The ability to build and maintain positive relationships with management, peers, and external contract organizations are essential
- Proven experience handling confidential and sensitive information with the ability to exercise discretion and show good judgment; honesty, integrity, and trust-building behaviors in all dealings is essential and required
Physical Demands Required:
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
- May encounter prolonged periods of sitting
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