Scientist I Bioassay (AS/QC)

Omeros Corporation; Seattle (WA); On-site; USD 105,000 - 130,000; Full time

Benefits offered by this job

Stock options

Medical/dental/vision coverage

Vacation and paid holidays

401(k) with company match

Job summary

Omeros Corporation in Seattle, WA is seeking a Scientist I, Bioassay (AS/QC) to support potency and cell-based bioassay activities across Analytical Sciences and Quality Control. You will develop, transfer, and qualify plate-based cell-based bioassays (ELISAs) and contribute to GMP oversight for clinical and commercial products.

The role requires hands-on experience with MOA biology, cell culture, and generation of large cell banks, with opportunities to manage external CROs/CDMOs and contribute

Qualifications

• PhD in Biochemistry, Bioengineering, Biology, or a related field; 0-3 years pharma/biotech experience.

Responsibilities

• Bioassay method development, testing, transfer, qualification and validation in both development and GMP (QC) environments
• Troubleshoot method and equipment challenges, including cell culture of challenging cell lines and QC integration
• Author standard test methods, technical reports, and qualification/validation reports
• Perform testing for in-process, release, characterization, comparability and stability
• Collaborate with cross-functional teams as Bioassay (AS/QC) representative
• Coordinate with CROs/CDMOs for method transfer and testing
• Investigations into deviations, OOS/OOT/OOC, method failures, root cause analyses
• Ensure lab equipment calibration and maintenance for GLP/GMP compliance
• Contribute to drafting regulatory submissions (IND/IMPD, BLA/MAA)
• Ensure methods development/execution meet regulatory requirements and project timelines
• Demonstrate collaborative relationships across functions and management
• Detail oriented, proactive, and self-motivated
• Must handle hazardous materials and travel up to 10%

Skills

Cell-based bioassay development

MOA understanding

ELISA/AlphaLISA/Lumit

Data analysis (JMP/Softmax Pro)

GMP/QA knowledge

Cross-functional collaboration

Education

PhD in Biochemistry/Bioengineering/Biology or related

BS with 10+ years cell-based bioassay experience

MS with 8+ years cell-based bioassay experience

Tools

Softmax Pro

JMP

ELNs/LIMS

Incucyte

Flow cytometry

Biosafety cabinets/plate readers

Job description

We are a fast-growing and dynamic organization seeking aScientist I, Bioassay (AS/QC)to provide strategic and technical background for potency and cell-based bioassay-related activities across Analytical Sciences and Quality Control. This position will be a part of a growing team of scientists responsible for the development and GMP oversight of bioassays supporting clinical and commercial products.

This role will be responsible for development, transfer, and qualification of plate-based cell-based bioassay and potency methods (including ELISAs), characterizing mechanism of action (MOA) attributes of therapeutic drug candidates, and developing new and orthogonal methods for extended characterization (such as IncuCyte, flow cytometry, or high-throughput liquid handlers). The ideal candidate has an excellent understanding of cell-based MOAs and therapeutic drug biology and should excel in cell culturing and generation of large cell banks for use in cell-based assays in development and GMP environments. This position will also contribute to tech transfer to clinical and commercial stage CRO’s/CMO’s and may contribute to managing external CRO’s who may develop and implement methods for routine testing and extended characterization.This position will be on-site at Omeros’ Seattle headquarters.

Good things are happening at Omeros!

Who is Omeros?

Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA®(narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials.

Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is 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, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com.

What are your job responsibilities?

• Bioassay method development, testing, transfer, qualification and validation in both development and GMP (QC) environments
• Troubleshoot method and equipment challenges, including troubleshooting and optimizing cell culture of challenging cell lines and introduction into QC environments
• Author standard test methods, technical reports summarizing analytical data, and qualification / validation reports
• Perform testing activities for in-process, release, characterization, comparability, and stability testing of clinical and commercial products
• Participate in cross-functional teams as a representative of the Bioassay (AS/QC) group
• Troubleshoot bioassay-related problems from third-party vendors, including CROs / CDMOs
• As applicable, perform investigations, including deviations, OOS/OOT/OOC results, test methods failures, and method-related root cause analyses
• Ensures laboratory equipment is calibrated and maintained in proper working order to enable compliance with GLP and/or GMP environments
• Contribute to drafting regulatory submissions (IND/IMPD, BLA/MAA, health authority responses)
• Ensure test methods development and execution activities are conducted in accordance with applicable regulatory requirements, internal policies, scientific standards, and project timelines

What education and experience do you need?

• PhD in Biochemistry, Bioengineering, Biology, or a related field with 0-3 years of experience in the pharmaceutical or biotechnology industry
• BS with 10+ years or MS with 8+ years of extensive cell-based bioassay experience in the pharmaceutical or biotechnology industry
• Strong hands-on experience developing cell-based bioassays, plate-based potency assays (e.g. ELISA, AlphaLISA, Lumit), and large mammalian cell banks
• Experience with potency assay statistical software (e.g. Softmax Pro, PLA, JMP)
• Experience in maintaining and qualifying equipment required for performing potency and cell-based methods, including incubators, biosafety cabinets, plate readers, and controlled-rate freezers
• Experience with orthogonal cell-based bioassay techniques, including IncuCyte, flow cytometry, and liquid handler implementation is a plus
• Strong understanding of cell-based mechanisms of action and relationship between potency and other critical quality attributes (CQAs)
• Capable of interpreting data and communicating and presenting results to peers and management
• Experience supporting GMP release and stability testing for clinical and/or commercial biologic products is preferred
• Proficiency in MS Office, Word, and Excel software is required; experience with electronic laboratory notebooks (ELNs), LIMS, and data analysis platforms is preferred
• Some knowledge of cGMPs, ICH guidelines, regulatory expectations, data integrity requirements, and Quality Management Systems is preferred
• Experience in qualification, transfer, and validation of bioassays, internal and in management of third-party CROs / CDMOs, is preferred

Behavioral Competencies Required:

• Demonstrated ability to build and maintain positive and collaborative relationships across functional areas and with management

Detail oriented, proactive, and self-motivated

Must display strong analytical, problem-solving, and multi-tasking capabilities

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
• This position may require travel up to 10% of the time

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 this position is$105,000 - $130,000. 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 visit www.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 send an e-mail to [e-mail].