Assoc Director/Director, Quality Control
- Employer
- Omeros Corporation
- Location
- Seattle, WA, United States
- Start date
- Feb 28, 2021
View more
- Discipline
- Quality, Quality Control
- Required Education
- Masters Degree/MBA
- Position Type
- Full time
- Hotbed
- BioForest
Job Details
Come join Omeros!
Come join our CMC Team!
Who is Omeros?
Omeros is a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G proteincoupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. The company also exclusively possesses a novel antibody-generating platform.
Primary 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, 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 Development 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
- MS or PhD in Analytical Chemistry or a related scientific field
- 10+ years Quality Control experience is required, preferably with both small molecules and biologics
- 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 inspection
- 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
- 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
- Occasionally required to travel overnight
- Ability to travel 10% of the time
- 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
- Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.
- May encounter prolonged periods of sitting
- This position requires working with and near hazardous material
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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.
Company
At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.
From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.
The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.
- Website
- https://www.omeros.com/
- Phone
- 206.676.5000
- Location
-
201 Elliott Avenue West
Seattle
Washington
98119
US
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