Sr. Research Associate, Formulations

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Senior Research Associate, Formulation Development

This position includes both a hands-on, laboratory-based role and managing outsourced projects to support formulation development activities of monoclonal antibodies and small molecules.

Formulation development activities will include excipient screening and optimization, stability testing and characterization of routes of degradation of proteins in liquid and lyophilized formulations under various stresses. Laboratory activities include buffer and protein solution preparation, pipetting and aseptic operations in a biosafety cabinet.

Activities in support of Drug Product manufacturing may be performed, which include mixing studies, process robustness and tech transfer activities.

This position may also support small molecule formulation development for early stage exploratory work through preclinical, clinical and commercial stages. Small molecule formulation development will include application of traditional and enabling technologies for bioavailability enhancement, solution/suspension development, powder characterization (flow, compactability, particle sizing, compressibility); tablet process development and scale-up, solubility and dissolution testing.

Good things are happening at Omeros!

Come join our Omeros CMC Team!

Who is Omeros?

True innovation requires the right people, and that's what we have at Omeros - smart, hard-working and creative individuals who collaborate and drive to achieve what has not yet been done. We see strength in diversity - diversity in thought, expertise and experience.

We have taken a similar approach in structuring our company. While many bio-techs pursue a single therapeutic area or scientific platform, we are strategically building a deep and diverse pipeline of first-in-class small-molecule and antibody therapeutics. The strength of our scientific discoveries and exclusive intellectual property positions enable our pipeline programs to target highly promising receptors and enzymes that others have not been able to develop.

Although cutting across a wide and diverse range of disorders and therapeutic indications - some orphan, others large-market and many for which there are no approved treatments - all of our drugs on the market and in development target critical unmet needs to improve the lives of patients in meaningful ways.

What are your job responsibilities?

• Design and execute formulation development and stability studies to support various phase-appropriate antibody drug candidates and small molecules

• Run routine analytical tests such as size exclusion chromatography, sub-visible particle analysis, viscosity, pH, protein concentration, and appearance

• Design and execute IV compatibility, in-use stability and microbial challenge studies to recommend clinical and commercial dosing strategy

• Develop fit-for-purpose analytical methods to support biophysical characterization, formulation stability, and compatibility testing

• Author technical transfer documents to internal and external manufacturing sites and support the process development and manufacturing of clinical drug substances and drug products

• Author formulation development and compatibility technical documents for internal use and to support regulatory filings

• Develop solid and liquid oral dosage form products from preclinical to clinical and commercial stage

• Apply a strong understanding of formulation and process development in scaling up formulations for oral administration

• Present work at group, departmental, and cross functional meetings

• BS degree in Life Sciences, Chemistry, Biochemistry, Pharmaceutical Sciences, Chemical Engineering, Bioengineering or a related field with 5+ years of experience is required or an MS degree with 2 + years of experience is required

• Experience with formulation development activities for monoclonal antibodies and novel protein-based molecules, IV admixture compatibility, microbial challenge study, or sterile product development and manufacturing is preferred

• Strong scientific understanding and experience with pharmaceutics, pharmaceutical science, pharmacy, protein chemistry, biophysical/biochemical characterization of proteins, bioanalytical method development or biomolecule product development

• Hands-on experience and trouble-shooting proficiency with column chromatographic (HPLC/UPLC), or biophysical techniques (such as DLS, CD, FTIR, DSC, AUC, fluorescence, HIAC, MicroFlow Imaging) for protein characterization

• Strong technical knowledge in solid oral dosage form development and scale-up

• Experience in developing and performing characterization of drug product formulations in the lab such as flow, particle sizing, surface area and density

• Demonstrable experience with various pharmaceutical unit operations such as high shear granulation, roller compaction, compression, fluid bed granulation, blending, milling, tableting and coating

• Demonstrable technical understanding of various analytical techniques such as powder x-ray diffraction, dissolution, and solubility testing

• Familiarity with drug product manufacturing and tech transfer support.

• Collaboration & Teamwork: Demonstrates the ability to relate to employees and management in a cooperative manner that helps others to achieve their best

• Productivity/Organizing/Planning: Demonstrates ability to meet deadlines, effectively use time, and handle multiple assignments simultaneously

• Communication Skills: Ability to convey both written and verbal information effectively and efficiently

• Willingness to Acknowledge Areas for Growth: Understands need for growth and is receptive to constructive feedback

• Detail-Oriented: Follows precise procedures and demonstrates thoroughness in performing job tasks and assignments

• Intermittent physical activity including bending, reaching, pushing, pulling, or lifting up to 40 lbs.

• May encounter prolonged periods of sitting or standing

• This position requires working around hazardous materials

If you have the experience, skills and knowledge we are seeking, we'd love to hear from you! This is an exciting opportunity for the right person!

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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000