As our Director of Analytical Development, you’ll be responsible for developing and managing analytical methods for both large and small molecule therapeutics. You’ll work with internal and external resources for the development of these methods and their technology transfer and validation to CMOs.
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:
Manages and mentors department of Associates and Scientists responsible for analytical method development, execution, qualification and validation for both small molecule and biologic modalities
Determine analytical priorities and strategies to achieve CMC-related objectives.
Lead product characterization, and product attribute criticality assessments from candidate nomination through IND- and BLA-/NDA-enabling activities and ultimately commercial registration
Lead product characterization activities, including comparability assessments in support of product life cycle management
Manage day-to-day group activities including timeline, budget management and objective setting in a growing analytical development group
Collaborate with external CTO partners and assess opportunities for bringing work in-house
Lead analytical-related regulatory reports and submissions, ensuring compliance with all applicable regulatory guidelines
Review and approve analytical results, protocols and reports
Assist in negotiation of third-party contracts including clinical and commercial supply agreements
Contributes to building a culture that encourages continuous learning, improvement and innovation, and encourages team members to expand their technical skill base
What education and experience do you need?
Ph.D. in Analytical Chemistry, Biochemistry, Biology or equivalent relevant industry experience with a MS or BS degree
10+ years’ experience in Analytical Development
Expertise with analytical method development, qualification and validation
Large molecule experience is required; experience with analytical techniques for small drug molecules including HPLC, LCMS, GS, UV/VIS, IR, PSA is desired
Excellent interpersonal and strong leadership skills with the ability to influence and liaise in a cross-functional team environment
Solid knowledge in applying analytical techniques to solve challenging problems
Experience with navigating global regulatory CMC documents
Familiar with GMPs, comparability protocols and qualification/validation practices
Experience leading CMC Teams or analytical sub teams required
Experience with startup biopharma company and/or at least one product launch desirable
Proficiency in MS Office, Word and Excel; statistical analysis software is desirable
Behavioral Competencies Required:
Demonstrated ability to build and maintain positive and collaborative relationships with management, peers, subordinates and externally with third party contract organizations
Excellent written and oral communication skills with a proven track record of developing employees
Self-motivated and detail-oriented, with the highest integrity.
Occasionally required to travel overnight
Ability to travel 10% of the time.
Management and Supervision of a small team and contractor(s)
Responsibilities may include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
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.