Director, Quality Control

We are a fast-growing and dynamic organization seeking a Director, Quality Control to join our CMC team. The Director, Quality Control will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations. This individual will be responsible for providing scientific leadership, defining QC strategy and determining a roadmap for QC related activities and operations to meet corporate objectives. The scope of this role covers all phases of product development (clinical and commercial) at Omeros for both large and small pharmaceutical products. What are your job responsibilities? Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP products Lead and manage QC staff including hiring, developing, evaluating and goal setting Oversee GMP clinical and commercial stability planning, execution, statistical data analysis and data trending in support of product expiry/shelf-life determination Oversee Quality Control requirements for compliance with cGMP regulations at external contract manufacturing and testing organizations Oversee product release and stability specification setting and COA generation Oversee and approve release of QC components of GMP manufacturing batch and test records at external contract organizations Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by the Omeros Technical CMC teams Partner with internal and external stakeholders to transfer, qualify and validate analytical methods Establish and maintain quality control standards applicable to the clinical and commercial product phases Author/review relevant sections of regulatory filing reports and submissions Drive continuous improvement projects in collaboration with internal and external stakeholders What education and experience do you need? PhD in Analytical Chemistry, Biochemistry, Biology or a related scientific field 10+ years Quality Control experience is required, preferably with both biologics and small molecules Strong knowledge of GMPs, ICH guidelines and Quality management systems Experience with analytical methods technology transfer to third parties Experience with regulatory authority meetings and GMP site inspections Extensive experience with analytical method development and validation Expertise with stability testing, data trending and expiry setting strategy Experience with testing injectable and oral dosage forms preferred Experience in big pharma/biotech; experience in a startup biopharma company is desirable Proficiency in MS Office, Word and Excel; statistical analysis software is desirable Behavioral Competencies Required: Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates, and externally with third party contract organizations Excellent written and oral communication skills with a proven track record of developing employees Self-motivated and detail-oriented, with the highest integrity Other Responsibilities: Occasionally required to travel Ability to travel 10% of the time Supervisory Responsibilities: Management and supervision of a small team and contractor(s) Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems 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 Director Quality Control position is ($210,000-$245,000). 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 incentive and stock options. To learn more about Omeros, please visit 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. #J-18808-Ljbffr