Sr. Scientist/Group Leader II, Analytical Development
Omeros has a new opportunity for a technical leader to join the Analytical Development & QC team who will be responsible for supporting early and late stage clinical development and commercialization of biological therapeutics. In this role, you’ll lead and manage the development and optimization of chromatographic (HPLC, UPLC) and/or electrophoretic (CE-SDS, cIEF, icIEF) methods, product characterization, and formulation development. Further, this position will manage method transfers, qualifications / validations, and release and stability testing in partnership with CROs/CMOs in support of global regulatory filings. You’ll also lead evaluations of orthogonal and complimentary technologies to add and improve technical capabilities, efficiency, and throughput within the group. Further, this role may have opportunities to manage direct report(s).
Good things are happening at Omeros!
Come join our CMC Group!
Who is Omeros?
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.
The company’s drug product OMIDRIA® (phenylephrine and ketorolac injection) 1% / 0.3% is marketed in the U.S. for use during cataract surgery or intraocular lens (IOL) replacement to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain. In the European Union, the European Commission has approved OMIDRIA for use in cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), prevent miosis (pupil constriction), and to reduce postoperative eye pain.
Omeros has multiple Phase 3 and Phase 2 clinical-stage development programs focused on: complement-associated thrombotic microangiopathies; complement-mediated glomerulonephropathies; Huntington’s disease and cognitive impairment; and addictive and compulsive disorders. In addition, Omeros has a diverse group of preclinical programs and a proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and corresponding compounds, a number of which are in preclinical development. The company also exclusively possesses a novel antibody-generating platform.
What are your job responsibilities?
- Leading and managing the development and optimization of chromatographic (HPLC, UPLC) and/or electrophoretic (CE-SDS, cIEF, icIEF) methods in support of early and late stage clinical development and commercialization both internally and in partnership with CROs and CMOs
- Managing tech transfer and qualification and/or validation of analytical methods to clinical and commercial stage CROs and CMOs
- Managing analytical development and extended characterization activities at CROs
- Leading and managing efforts and activities to support global regulatory filings
- Leading evaluations of orthogonal and complimentary technologies to improve technical capabilities, efficiency, and throughput within the group
- May be responsible for leading and managing others
What education, experience, skills, and knowledge do you need?
You’ll need to have a PhD in Chemistry, Biochemistry, Analytical Development or a related field with 6+ years of biotechnology and/or pharmaceutical industry experience; a BS/MS degree with 10+ years of experience will also be considered. In addition, candidates should have the following experience:
- Strong understanding of technical principles of chromatographic and/or electrophoretic methods
- Experience developing robust HPLC (SEC, RP, peptide map, CEX, etc.) and/or CE-based (CE-SDS, cIEF, icIEF) methods
- Experience with troubleshooting, optimizing, transferring, and qualifying/validating analytical methods
- Experience working with collaborative cross-functional teams including functional area representatives from Research, Nonclinical, QC, QA, Regulatory, project management, and Process Development
- Familiarity with ICH, FDA, and USP guidance
- Demonstrated capability of interpreting data and communicating and presenting results to peers and management
- Demonstrated written and verbal communication skills with peers and management
- Demonstrated problem-solving and multi-tasking abilities
- Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management
- A track record of successfully managing activities and relationships and meeting timelines within an organization and in collaboration with external partners
- The ability to work well in a collaborative, fast-paced project team environment
- Detail oriented, proactive, and self-motivated
Additional experience, skills, and knowledge our ideal candidate has:
As our ideal candidate, you’ll need the following skills and knowledge:
- Experience developing stable formulations and executing stability studies for biologic and/or pharmaceutical products
- Experience managing, leading, and coaching direct reports
- Experience and proficiency with Waters Empower software
- Experience developing, optimizing, troubleshooting, and interpreting results from LC-MS assays
If you have the skills, knowledge and experience we are looking for, we’d love to hear from you!