Director/Sr. Director, Analytical Sciences

Omeros • Seattle, WA

3d • $215,000 - $280,000

About The Position

We are a fast-growing and dynamic organization seeking a Director/ Sr Director Analytical Sciences to join our CMC team. The Director / Sr Director Analytical Sciences will be responsible for developing and managing drug substance (DS) and drug product (DP) specifications, reference standard, in-process testing, DS and DP release and stability 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. Good things are happening at Omeros! Come join our Marketing Team! Who is Omeros? Omeros is an innovative biotechnology company that discovers, develops, and commercializes first-in-class small-molecule and protein therapeutics for large-market and orphan indications, with particular emphasis on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead lectin pathway inhibitor YARTEMLEA ® , which inhibits the pathway’s effector enzyme MASP-2, is FDA-approved for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients ages two years and older, with a planned U.S. launch in January 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by the European Medicines Agency, with a decision expected in mid-2026. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), a MASP-3 inhibitor in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder and fully funded by the National Institute on Drug Abuse, as well as a growing portfolio of novel molecular and cellular oncology programs. For more information about Omeros and its programs, visit www.omeros.com .

Requirements

• Ph.D. in Analytical Chemistry, Biochemistry, Biology or equivalent relevant industry experience with a MS or BS degree
• 15+ years of experience in Analytical Sciences
• Expertise with analytical method development, qualification and validation
• Large molecule experience is required; hands on 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
• 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 and subordinates and lead cross-functional technical teams
• 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 team (10+ Associates/Scientists)
• Responsibilities may include interviewing, hiring and training employees; timelines, cost, and resource planning, assigning and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Nice To Haves

• Experience with startup biopharma company and/or at least one product launch desirable

Responsibilities

• 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 for early-stage development programs as well as commercial products.
• Lead product characterization, and product attribute criticality assessments from candidate nomination through IND- and BLA/NDA-enabling activities and ultimately commercial registration
• Author Module 3 IND/IMPD and BLA/MAA sections and address health authorities CMC inquiries as appropriate.
• 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 sciences group
• Collaborate with external CMO 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.
• Lead investigations and resolve deviations as necessary.
• 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

Benefits

• Employees are offered medical, dental, vision, life insurance, and a 401(k) plan with a company match.
• Employees accrue three weeks of vacation and 80 hours of sick time on an annual basis and receive twelve paid holidays throughout the calendar year.
• This position is eligible for incentive and stock options.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree