Scientist I, Analytical Development
Scientist I, Analytical Development
This position will primarily be responsible for the development, transfer, qualification, and validation of potency bioassays in support of clinical development and commercialization of antibody therapeutics. The Scientist may also contribute to the development, transfer, and qualification / validation of impurity ELISAs and analytical HPLC and/or CE methods to monitor physicochemical quality attributes for both protein and small-molecule therapeutics. The individual will develop and implement methods for characterization, contribute to tech transfer to clinical and commercial stage CROs / CMOs, and provide input to and manage external CROs who may develop and implement methods for characterization, release, and stability testing.
Come join our highly talented CMC Team and help shape the future of Omeros!
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 protein-coupled 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. www.omeros.com
Your specific job responsibilities will include:
- Analytical method development, testing, transfer, qualification, and validation in a GLP and/or GMP environment
- Troubleshoot typical method and equipment challenges
- Write standard test methods, technical reports summarizing analytical data, and qualification / validation reports
- Participate in cross-functional teams as a representative of the Analytical Development group
- Assists in trouble-shooting CMC-related problems from CROs / CMOs
- Assists in investigations involving data generated internally and by CROs / CMOs
- Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
- Contribute to drafting regulatory submissions
- Ensures compliance with all applicable regulatory guidelines
- Demonstrated knowledge and experience developing potency ELISAs for protein therapeutics and interpreting data is required
- Knowledge and experience transferring, troubleshooting, and validating assays is required
- Knowledge and experience developing HPLC and/or CE based methods is a plus
- Small and large molecule experience is desired
- Demonstrated problem-solving capabilities
- Knowledgeable in global regulatory CMC documents
- Familiar with GMPs and qualification / validation practices
- ≥1 (for Ph.D.) or ≥8 (for B.S.) years of biotechnology and/or pharmaceutical industry experience required
- BS, MS or Ph.D. in biology, biochemistry, analytical chemistry, or a related field
- Experience with "start-up" biopharma company desirable
- Excellent communication, analytical, and organizational skills required
- Must have the ability to build and maintain positive and collaborative relationships with management and peers
- Excellent written and verbal communication skills required
- Must display strong analytical and problem-solving skills
- Attention to detail required
- 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
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 email@example.com or contact Omeros, asking for Human Resources, at (206) 676-5000.