Location: Seattle,WA, USA
Position Summary:
This position leads the global supply chain function, including procurement, inventory forecasts, planning & management, and logistics to ensure a reliable supply of safe, high-quality drug products for Omeros and relevant placebos and active comparators. The position leads the development, implementation and maintenance of supply chain policies, procedures, and control systems to reduce costs, streamline procedures, and ensure regulatory compliance of the global supply chain. In collaboration with the relevant team members, this position is responsible for identifying, selecting, negotiating agreements with, and managing various CMC vendors including, but not limited to, those providing raw materials (APIs, excipients, packaging), packaging, labeling, shipment services, GMP storage of API, Drug Product, and final finished goods. Working with clinical and commercial teams to understand anticipated needs, ensures the availability of drug product in the supply chain, as scheduled, and the maintenance of inventory at acceptable levels.
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 immunologic disorders including complement-mediated diseases, as well as cancers and addictive and compulsive disorders. 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. Omeros' long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1 multi-ascending-dose clinical trial. OMS906, Omeros' inhibitor of MASP-3, the key activator of the alternative pathway of complement, is advancing toward Phase 3 clinical trials for paroxysmal nocturnal hemoglobinuria and complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros' lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder and, in addition, is being developed as a therapeutic for other addictions as well as for a major complication of treatment for movement disorders. Omeros also is advancing a broad portfolio of novel immuno-oncology programs comprised of two cellular and three molecular platforms. For more information about Omeros and its programs, visit www.omeros.com.
Essential Duties & Responsibilities:
* This role participates in and leads employees, contractors, and vendors in the procurement, planning, manufacturing, inventory management & logistics of the global supply chain
* Directs sourcing and supplying of raw materials, utilities, and outside services, as well as coordinating global commercial and clinical procurement efforts
* Leads drug and clinical supply and inventory planning and forecasting for the company - working across functions (CMC, Clinical Operations, Quality Assurance, Regulatory, Sales, and Finance); Works with finance/accounting on matters involving inventory-carrying costs; Reviews and plans requirements for acceptable inventory
* Establishes, implements, and manages procurement processes and procedures; Determines KPI's for vendors and leads business reviews for key vendors
* Leads the selection and management of vendors to meet supply chain objectives and comply with inventory policies
* Works with colleagues in CMC, QA, commercial, clinical, and regulatory affairs to ensure appropriate selection and oversight of vendors
* Selects, develops, and evaluates employees, contractors, and vendors to ensure the efficient operation of the function
* Proactively identifies, monitors, and addresses supply chain risks
* Develops short- and long-term goals for the supply chain efforts in support of regulatory submissions, clinical and commercial efforts, and program-driven milestones
* Collaborates across the CMC function and with Quality Assurance to plan and implement the execution of cGMP activities in support of both clinical and commercial supply chain
* Promotes adaptation and flexibility in a rapidly changing environment. Acts as a change leader through team building and influence
* Develops and leads a culture of learning, respect, and employee growth; Establishes the department's strategic vision and mentor the CMC operations team towards goal achievement
Education, Experience, Skills, and Knowledge Required:
* Bachelor's degree in Business, Logistics Management, Chemistry, or equivalent is required; M.S. in Biology, Chemistry or related field is preferred
* Twelve (12) to Fifteen (15) years of relevant experience in supply chain management, including 7 - 10 years in biotech or pharmaceutical supply chain management and a minimum of 5 years in a supply chain leadership capacity (dependent on the level)
* Strong organizational and leadership skills to coordinate evolving supply chain timelines and the ability to develop risk-based approaches for the rapid sourcing of materials and release of products
* Strong communication and partnership with CMC, supply chain, and regulatory teams
* The successful candidate will have a demonstrated track record of technical and strategic leadership
Behavioral Competencies Required:
* Leads by creating a positive environment of open communication and staff development
* Delegates work assignments to staff as appropriate, considering employee strengths and expertise to address associated tasks
* Mentors individuals, based on individual needs, to meet current job expectations and career goals
Travel Requirements:
* This position requires domestic and international travel to meet with and monitor global suppliers if in-person meetings and monitoring activities are needed to conduct business most efficiently
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 may require working around hazardous materials located within the building
Compensation and Benefits
Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for the Director/Sr. Director, Supply Chain and Procurement is $190,000 - $240,000. Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match. Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year. This position is eligible for bonus and stock options. To learn more about Omeros, please visit?www.omeros.com.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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 ...@omeros.com or contact Omeros, asking for Human Resources, at (206) ###-####.