Director, Quality Control

Position Summary:

Omeros is seeking a Director of Quality Control (QC) who 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 molecule programs.

Responsibilities include:

• Lead Quality Control (QC) activities for clinical and commercial products, including management of in-process and release testing of GMP Biologics and small molecule products.
• Lead and manage QC staff including hiring, developing, evaluating and goal setting.
• Oversee GMP clinical and commercial stability planning, execution, 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.
• Develop Quality Control strategy and direction in conjunction with the development of analytical methods and manufacturing processes by the Omeros Technical Development teams.
• Author/review relevant sections of regulatory filing reports and submissions.
• Drive continuous improvement projects in collaboration with internal and external stakeholders.

Experience and Education Required:

• MS or PhD in Biochemistry or a related scientific field.
• Experience in Biologics QC required, with 10+ years of experience.
• Strong knowledge of GMPs, ICH guidelines and Quality management systems.
• Experience with technology transfer to third parties.
• Experience with regulatory authority meetings and GMP site inspections.
• Extensive experience with analytical method qualification and validation.
• Expertise with stability testing, data trending and expiry setting strategy.
• 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 overnight.
• 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.

Physical Demands Required:

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting to 40 lbs.
• May encounter prolonged periods of sitting.
• This position requires working with and near hazardous material.

Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases and disorders of the central nervous system. 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. It is also 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

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.