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Director/Sr. Director, Analytical Development

Employer
Omeros Corporation
Location
Seattle
Start date
Sep 15, 2020

View more

Discipline
Information Technology, Business/Data Analytics
Required Education
Associate Degree
Position Type
Full time
Hotbed
BioForest

Job Details

Good things are happening at Omeros!

Come join our CMC Omeros Team!

As our Director/Sr. 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 and orphan indications targeting inflammation, complement-mediated diseases, disorders of the central nervous system and immune-related diseases, including cancers. In addition to its commercial product OMIDRIA (phenylephrine and ketorolac intraocular solution) 1%/0.3%, Omeros has multiple phase 3 and phase 2 clinical-stage development programs focused on complement-mediated disorders and substance abuse. Omeros also has a diverse group of preclinical programs including GPR174, a novel target in immuno-oncology that modulates a new cancer immunity axis recently discovered by Omeros. Small-molecule inhibitors of GPR174 are part of Omeros' proprietary G protein-coupled receptor (GPCR) platform through which it controls 54 new GPCR drug targets and their corresponding compounds. 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
  • 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
  • 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
  • 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 hr@omeros.com or contact Omeros, asking for Human Resources, at (206) 676-5000.

Company

At Omeros, we are proud of our innovative and cutting-edge science. Our world-class team has achieved scientific advances that no other group has been able to accomplish, delivering wholly new classes of therapeutics to benefit patients. We let science lead the way.

From our foundation of groundbreaking science, we continue to build and advance a deep and diverse pipeline of small-molecule and protein therapeutics. We are not interested in developing “me-too” products; instead, we are focused on tackling challenging diseases and disorders with significant unmet medical needs. The result is an exciting pipeline of first-in-class drugs with new mechanisms of action that target previously untapped receptors and enzymes.

The Omeros team is exceptionally talented, passionate, collaborative and diverse. We hire smart, creative and hard-working people who want to play a meaningful part in building a preeminent biopharmaceutical company. We come from all corners of the globe, bringing unique abilities and experiences together to provide hope to patients and their families.

Company info
Website
Phone
206.676.5000
Location
201 Elliott Avenue West
Seattle
Washington
98119
US

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