Research Associate II / Sr. Research Associate, Analytical Development
This position will support preclinical and clinical development and commercialization of small molecules. The Research Associate will bring a strong technical background including development, transfer, and qualification of analytical methods, characterizing physicochemical attributes of therapeutic candidates, developing new and orthogonal methods for extended characterization, and evaluating orthogonal and complimentary technologies to improve throughput. This position will also contribute to tech transfer to clinical and commercial stage CRO’s/CMO’s and may contribute to managing external CRO’s who may develop and implement methods for routine testing and extended characterization.
Good things are happening at Omeros!
Come join our Omeros CMC Team!
Who is Omeros?
Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market and orphan indications targeting inflammation, immunologic diseases (e.g., complement-mediated diseases) and cancers. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Narsoplimab is also in multiple late-stage clinical development programs focused on other complement-mediated disorders, including IgA nephropathy, atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in a Phase 1 clinical trial. For more information about Omeros and its programs, visit www.omeros.com.
What are your job responsibilities?
- Experience developing robust HPLC method for assay and related substances of small molecule
- Experience with using chromatographic software, such as Empowers, is a must
- Experience with troubleshooting and optimizing methods
- Experience with routine lab equipment and methods, including preparing buffers, measuring pH, UV absorbance, quantifying particulates, etc.
- Experience and proficiency with Waters Empower and/or Sciex 32 Karat software is highly desired
- Experience with technology transfer to third parties is desired
- Strong understanding of technical principles of chromatographic and/or electrophoretic methods
- Capable of interpreting data and communicating and presenting results to peers and management
- Demonstrated written and verbal communication skills with peers and management
- Supports preparation and maintenance of program annual reports, and may support CMC, nonclinical, pharmacovigilance and other routine regulatory programs and other routine regulatory filings
- Conducts internet searches on regulatory topics to support development programs and department and company compliance
- Provides technical review of data or reports to be incorporated into regulatory submissions to ensure scientific rigor, accuracy, and clarity of presentation
- Coordinates, prepares, or reviews regulatory submissions for domestic and/or international projects
- If supporting a marketed product, reviews product promotional materials and labeling for compliance with applicable regulations and policies
- Communicates with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, as well as clarification and follow-up of submissions under review
- Ensures compliance with applicable regulations and guidelines (e.g., FDA, EMA, ICH)
- Interacts with and may have some oversight of vendor/contract research organization activities
- Escorts government inspectors during inspections and provides post-inspection follow-up information as requested
- Interprets regulatory rules or rule changes and ensures they are incorporated into corporate policies and procedures as appropriate Assists in writing or updating standard operating procedures, work instructions, or policies
- Advises project teams on subjects such as premarket regulatory requirements, labeling requirements, or clinical study regulatory compliance issues
- Identifies relevant guidance documents, international standards, or consensus standard and provides interpretive assistance
- Participates in internal or external audits
- Reviews clinical protocols to ensure collection of data needed for regulatory submissions.
- Coordinates recall or market withdrawal activities as necessary
- Manages regulatory tasks within time and budget of approved project plans
Education, Skills and Knowledge:
- BS or MS degree in Biochemistry, Biology, or a related field with 2 - 5 years of biotechnology and/or pharmaceutical industry experience for a RA II or 5 – 8 years for a Sr. Research Associate
Behavioral Competencies Required:
- Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management
- Detail oriented, proactive, and self-motivated
- Must display strong analytical, problem-solving, and multi-tasking capabilities
Physical Demands 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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000