Vice President, Chemistry, Manufacturing & Controls (CMC)
We are a growing and dynamic organization seeking a Vice President, CMC to join our executive team and lead our CMC organization. Reporting to the CEO, you will be responsible for all CMC aspects of the Company’s drug substances and drug products including discovery support, development and commercial manufacturing. You will be responsible for the initial commercial launch and continued supply of marketed products. Additionally, you will lead and direct formulation, process, analytical development, manufacturing, and quality control for both biological and chemical drug substances and products as well as oversee procurement and logistics and will ensure compliance with all applicable regulatory guidelines. You will be responsible for all activities required for the supply of clinical trial drug products and oversee and direct all CMC-related regulatory reports and submissions.
Good things are happening at Omeros!
Come join our Omeros 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:
- Overseeing and directing the formulation development, analytical method development, process development, and manufacture of both biological and chemical drug products and substances
- Overseeing and directing quality control
- Ensuring compliance with the relevant quality and safety guidelines, and the Company’s quality assurance program
- Having responsibility for the Company’s logistics strategy and oversight of supply chain management activities to deliver products for non-clinical and clinical trials, as well for commercial distribution, with appropriate quality and cost standards
- Negotiating third party contracts, including commercial supply agreements
What education and experience do you need?
- You’ll need to have a PhD in a core scientific discipline in this domain or equivalent and a minimum of 12 years of relevant CMC experience
- Industry experience with expertise in drug development, operations and strategic planning; experience with successful regulatory submissions from investigational new drug through new drug/biologic license application filings and experience managing a product from pre-clinical through all clinical phases and product launch
- Significant experience in successfully managing complex development projects
- Strong written and verbal communication skills with the demonstrated ability to communicate effectively and professionally
What knowledge and skills does our ideal candidate have?
- A demonstrated, in-depth knowledge of drug development and the relevant regulatory guidelines
- Expert knowledge of scientific principles and concepts in CMC, with a preference for candidates skilled in bioprocess development of antibodies
- Demonstrated ability to coordinate across multiple organizations to achieve challenging timetables
- Reputation as a leader in the field with sustained performance and accomplishment
- Excellent interpersonal and management skills with the ability to maintain positive relationships with management, peers, subordinates, and external contract organizations
- Effective and clear communicator, verbally and in writing, and have demonstrated proficiency preparing regulatory documents
- Display strong analytical and problem-solving skills
- Demonstrated leadership skills
- Ability to adapt to change
- Ability to maintain confidentiality of sensitive information
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 firstname.lastname@example.org or contact Omeros, asking for Human Resources, at (206) 676-5000.