Director, Quality Control

About the role

Omeros is seeking a Director, Quality Control to join our CMC team. This individual will provide strategic leadership in managing a growing team of scientists responsible for QC-related activities and operations, 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) for both large and small pharmaceutical products.

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

Qualifications

• 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

Skills

• 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

Pay

• Wage scale: $210,000-$245,000 (determined based on knowledge, skills, education, and experience relevant to the role)

Benefits

• Medical, dental, vision, and life insurance
• 401(k) plan with company match
• Three weeks of vacation accrued annually
• 80 hours of sick time accrued annually
• Twelve paid holidays per calendar year
• Eligibility for incentive and stock options

Schedule

• Occasional travel required (10% of the time)

Supervisory Responsibilities: Management and supervision of a small team and contractor(s), including interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.