Formulation Development Manager
We are a growing and dynamic organization seeking a Formulation Development Manager to join our CMC team. Reporting to the VP, CMC, you will be responsible for developing formulations and formulation processes for both large and small molecule therapeutics, given by various routes of administration including parenteral and oral administration. You’ll work with internal and external resources for the development of these formulations and their transfer to cGMP manufacturing.
Good things are happening at 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 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 intraocular solution) 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?
Your responsibilities in this position will include:
- Responsibility for CMC aspects of the Company’s formulation development through and including manufacturing
- Providing non-clinical formulation support for research, drug safety and PK studies
- Developing formulations to meet our clinical and commercial needs
- Leading formulation related regulatory reports and submissions
- Ensuring compliance with all applicable regulatory guidelines
- Assisting in negotiation of third party contracts including clinical and commercial supply agreements
What education and experience do you need?
- You’ll need to have PhD in Pharmaceutics, Chemical Engineering, or a related field or equivalent relevant industrial experience with a MS or BS degree
- 4+ years of biotechnology and/or pharmaceutical industry experience is required
- Experience with contract manufacturing and/or at least one product launch is desired
- Experience with injectable and oral dosage forms is preferred
- Strong written and verbal communication skills with the demonstrated ability to communicate effectively and professionally
What knowledge and skills does our ideal candidate have?
- Demonstrated knowledge of solid oral dosage formulations is required
- Demonstrated problem-solving capabilities
- Ability to navigate global regulatory CMC documents is required
- Familiarity with GMPs, manufacturing unit operations, and process validation practices
- Demonstrated successful team leadership skills
- Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external organizations
- Display strong analytical and problem-solving skills
- Ability to adapt to change
Other things you need to know:
- Occasionally, you’ll be required to travel overnight
If you have the experience, skills and knowledge that 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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.