Director/Sr. Director, Analytical Sciences
Omeros Corporation, Seattle, Washington, us, 98127
Director/Sr. Director, Analytical Sciences
Seattle, WA, United States
Job Description 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!
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 plannedU.S.launch inJanuary 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by theEuropean 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 Nordiskacquired 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 theNational 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, visitwww.omeros.com .
What are your job 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
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
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
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 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
Other Responsibilities:
Occasionally required to travel overnight
Ability to travel 10% of the time
Supervisory Responsibilities:
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.
Compensation and Benefits:
Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for Director / Sr Director Analytical Sciences position is(Dir = $215,000-$235,000; Sr Dir = $250,000-$280,000). Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. 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. To learn more about Omeros, please visitwww.omeros.com.
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.
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Job Description 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!
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 plannedU.S.launch inJanuary 2026. A marketing authorization application for YARTEMLEA in TA-TMA is currently under review by theEuropean 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 Nordiskacquired 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 theNational 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, visitwww.omeros.com .
What are your job 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
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
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
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 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
Other Responsibilities:
Occasionally required to travel overnight
Ability to travel 10% of the time
Supervisory Responsibilities:
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.
Compensation and Benefits:
Omeros is proud to offer a competitive total compensation package designed to support the lives of our employees and their families. The wage scale for Director / Sr Director Analytical Sciences position is(Dir = $215,000-$235,000; Sr Dir = $250,000-$280,000). Salaries will be determined based on knowledge, skills, education, and experience relevant to the role. 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. To learn more about Omeros, please visitwww.omeros.com.
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.
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