This position is on-site in Seattle, WA.

Join Lumen Bioscience as a Clinical Operations Manager to play a vital role in overseeing and coordinating the clinical operations activities within our growing biopharmaceutical company. In this role, you’ll collaborate with cross-functional teams, and manage CROs and clinical research sites, while ensuring the successful execution of clinical trials, adherence to regulatory guidelines, and the timely delivery of high-quality clinical data.

This position combines hands-on leadership of clinical operations activities with clinical trial oversight, relationship management, clinical sample management, clinical trial supply management, documentation and data management, and process improvement. You’ll oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, collaborate with CROs and clinical trial sites, and oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting. You’ll assist with forecasting and managing inventory of investigational product, manage relationships with third-party vendors, oversee investigational product shipments domestically and internationally, and oversee the collection, processing, and archival of clinical trial data and documents while identifying opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation. If you have strong leadership skills, in-depth knowledge of clinical research processes, and thrive in a fast-paced environment, we encourage you to apply.

Duties & Responsibilities:

• Clinical Trial Oversight:
  • Oversee the planning, implementation, and execution of clinical trials in collaboration with cross-functional teams, including regulatory affairs, medical writing, production and development, and data management.
  • Ensure compliance with study protocols, Good Clinical Practice (GCP) guidelines, and relevant regulatory requirements.
  • Monitor clinical trial progress, identify potential issues, and proactively develop and implement corrective actions.
• Relationship Management:
  • Collaborate with Contract Research Organizations (CROs) and clinical trial sites to ensure efficient study start-up, enrollment, and conduct.
  • Facilitate effective communication and build strong relationships with external partners, including investigators, site personnel, and vendors.
  • Serve as the main point of contact for clinical trial-related inquiries and issue resolution.
• Clinical Sample Management:
  • Oversee and supervise clinical trial sample management life cycle to maintain chain-of custody in a GxP compliant setting
  • Work closely with CRO, external lab vendors and internal teams to plan and execute sample processing, tracking and shipment of clinical samples
  • Oversee sample receiving procedures and sample testing timelines
• Clinical Trial Supply Management:
  • Assist with forecasting and managing inventory of investigational product needed for upcoming and ongoing clinical trials
  • Establish packaging, labeling and distribution timelines
  • Manage relationships with third-party vendors, e.g., shipping companies and IRT providers.
  • Oversee investigational product shipments domestically and internationally, including coordination of import/export documentation, permits and licenses to ensure timely and compliant delivery of investigational product to drug depots and clinical research sites.
• Documentation and Data Management:
  • Oversee the collection, processing, and archival of clinical trial data and documents, ensuring accuracy, completeness, and traceability.
  • Collaborate with the data management team to implement efficient data capture and reporting processes.
  • Ensure compliance with data protection regulations and maintain data confidentiality.
• Process Improvement:
  • Identify opportunities to streamline clinical operations processes, enhance efficiency, and optimize resource allocation.
  • Contribute to the development and implementation of standardized operating procedures (SOPs) and best practices.
  • Stay up to date with industry trends and regulatory changes to ensure the adoption of current best practices.

Qualifications & Requirements:

• Education and Experience:
  • Bachelor's degree in life sciences or a related field (advanced degree preferred).
  • Minimum of 8 years of experience in clinical operations, with a demonstrated track record of managing clinical trials.
  • Strong knowledge of GCP guidelines, FDA regulations, and other relevant regulatory frameworks.
  • Proven experience in leading and managing teams, with excellent organizational and interpersonal skills.
• Skills and Attributes:
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications.
  • Excellent written and verbal communication skills, with the ability to effectively communicate complex information to diverse stakeholders.
  • Detail-oriented, with strong problem-solving and decision-making abilities.
  • Ability to work effectively in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
  • Demonstrated ability to adapt to changing circumstances and proactively drive process improvements.

Physical Requirements:

• Ability to work on-site in Seattle, WA
• Ability to sit for extended periods of time (2 or more hours)

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.

This position is on-site in Seattle, WA.

Join Lumen Bioscience as a Senior Clinical Operations Manager to plan, execute and continuously improve clinical operations across multiple clinical studies. In this strategic, cross-functional role, you’ll lead operational strategy and execution for one or more clinical development programs, oversee CRO and vendor selection and performance, manage study budgets and timelines, ensure regulatory readiness and inspection response, and support the career development of the operations team while being accountable for delivering high-quality data on time and on budget.

This position combines program ownership and strategy, team leadership, CRO and vendor management, budget and resource ownership, quality and compliance, clinical trial execution, data and documentation, process improvement and SOPs, and cross-functional leadership. You’ll create program timelines, resourcing plans, and run-rate forecasts; manage vendor KPIs and SLAs and drive performance improvements; own program budgets and control spend; ensure inspection readiness and lead remediation after audits; oversee site selection and activation, enrollment performance, monitoring strategy, and vendor deliverables; ensure eTMF completeness and adherence to GCP/ICH and applicable regulations; and drive continuous improvement and implementation of SOPs and automation to increase efficiency and quality while presenting program status to leadership and the executive team.

If you bring deep clinical operations experience, strong leadership, communication, negotiation and problem-solving skills, and a passion for advancing clinical development programs, we encourage you to apply.

Duties & Responsibilities:

• Program Strategy & Execution: 
  • Lead operational strategy and execution for one or more clinical development programs (Phase I–III or platform trials).
  • Create program timelines, resourcing plans, and run-rate forecasts.
  • Oversee site selection/activation strategy, enrollment performance, monitoring strategy (RBM), SIVs, close-out, and vendor deliverables.
  • Escalate and resolve issues that threaten timelines or data quality.
• Team & Vendor Leadership: 
  • Mentor Clinical Ops Managers/CRAs; recruit, mentor, and develop talent; run performance reviews and succession plans.
  • Manage vendor KPIs/SLAs, run vendor governance, and drive performance improvements.
  • Hold CROs accountable for timelines, data quality, monitoring, and TMF completeness.
• Budget & Resource Management: 
  • Own program budgets; provide accurate forecasting and control spend.
  • Approve study-level operational expenses within delegated authority.
• Quality, Compliance & Documentation: 
  • Ensure inspection readiness and lead remediation after internal or external audits.
  • Accountable for issues escalation and coordination of inspection/agency responses.
  • Ensure eTMF completeness, timely monitoring visit documentation, query resolution, and adherence to GCP/ICH and applicable regulations (FDA, EMA, local).
  • Work closely with Data Management and Safety to ensure integrated delivery.
• Process Improvement & Cross-Functional Leadership: 
  • Drive continuous improvement; implement SOPs and automation (CTMS/EDC/eTMF optimizations) to increase efficiency and quality.
  • Present program status to leadership and the executive team.

Qualifications & Requirements:

• Education and Experience:
  • MS/PharmD/PhD preferred; BS with robust experience considered
  • Minimum of 12 years of clinical operations experience, including program/CRO oversight and people management
  • Demonstrated ownership of Phase I–III trials and experience supporting IND/CTA filings
  • Experience in biologics or oral/edible drug delivery modalities
  • Prior inspection response ownership or regulatory submission leadership
• Skills and Attributes:
  • Strong working knowledge of CTMS, eTMF, EDC platforms
  • Proficiency in clinical trial management systems (CTMS), electronic data capture (EDC) systems, and other relevant software applications
  • Deep familiarity with ICH-GCP, FDA/EMA regulations and inspection processes
  • Strong leadership, communication, negotiation and problem-solving skills
  • ACRP or SOCRA certification

Physical Requirements:

• Ability to work on-site in Seattle, WA
• Ability to sit for extended periods of time (2 or more hours)

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.

Join Lumen as a Lab Technician on our Strain Engineering team. In this role, you will help advance Lumen’s early and mid-stage spirulina pipeline. Your work will center on maintaining and assessing cyanobacterial cultures and on keeping our strain engineering workflows running smoothly.

You will assist across recombinant DNA construction, genome editing, protein expression screening, and analytical characterization. You will maintain and generate cryogenic stocks of spirulina cell lines, perform media prep and aseptic techniques, monitor growth and quality metrics, and document results in Lumen’s ELN. You will follow and help refine SOPs, operate and care for lab instruments, track samples and reagents, and ensure data are complete, reproducible, and audit ready.

You will contribute as a dependable teammate in a fast-paced, cross-functional environment. That includes learning and integrating new technologies, sharing capabilities with partner teams, coordinating to meet milestones and deadlines, and raising quality or troubleshooting issues as they arise. You will communicate status clearly in meetings at the team level and across the company. Success in this role requires strong organization, meticulous record keeping, flexibility, and the independence to learn new techniques while delivering reliable results.

Duties & Responsibilities:

• Strain Engineering and Characterization
  • Grow, maintain, characterize and cryopreserve cyanobacterial cultures; perform sterile handling, media preparation, and passaging.
  • Genotype spirulina strains and maintain accurate records of strain identity.
  • Conduct protein expression experiments and analyze results by SDS-PAGE and Western/Jess; perform ELISA-based titer/functional assays.
  • 20-40% of lab time: assist in cloning tasks such as Golden Gate assembly, plasmid miniprepping, clonal screening, sequencing and cryobanking.
• Laboratory Techniques and Data Management:
  • Follow established SOPs; optimize or develop new protocols to meet experimental goals with appropriate controls and statistical rigor.
  • Prepare reagents, buffers, and media; manage consumables for assigned workflows.
  • Perform sequencing sample preparation; analyze sequence data to confirm constructs/edits.
  • Maintain accurate, well-organized laboratory notebooks and sample/strain inventories; document work in Benchling (or equivalent ELN/LIMS) with timely written reports and data packages.
  • Summarize and present findings to supervisors and cross-functional stakeholders; contribute to SOP authoring, protocol updates, and continuous improvements in quality and efficiency.
• Laboratory Operations and Collaboration:
  • Dedicate ~10% of time to supporting general lab operations (maintenance, clean-up, equipment upkeep, inventory, and safety compliance).
  • Work independently while collaborating effectively with Physiology, Protein Expression, Process Development, and Manufacturing teams to meet project milestones.
  • Proactively learn and master new techniques, instruments (e.g., liquid handlers/automation, photobioreactors), and software to enhance laboratory capabilities.

Qualifications & Requirements:

• Education and Experience:
  • BA/BS degree in molecular biology, biochemistry, biotechnology, or a related field.
  • Minimum of two years of applied molecular biology experience. Research experience outside of the classroom strongly preferred. 
  • Proficiency in molecular biology techniques including cloning, DNA isolation, PCR, SDS-PAGE, and vector construction is required.
• Skills and Attributes:
  • Strong attention to detail and organizational skills.
  • Self-starter with the ability to adapt and contribute effectively in a fast-changing environment, and to work independently and in a team-oriented environment.
  • High level of integrity, ethics, and commitment to quality and timely delivery of results.
  • Effective communication skills to coordinate with team members and provide status updates.

Physical Requirements:

• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 20 kg
• Ability to perform delicate manual procedures in the laboratory

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.

This position is on-site in Seattle, WA.

Join Lumen Bioscience as a Scientist II, Process Development to lead the development, optimization, and qualification of scale-down models for upstream and downstream processes supporting complex biologics in an innovative early-stage manufacturing environment. In this role, you will apply process modeling DoE strategies to maximize product potency and productivity, design and execute complex experimental studies using sound statistical methodologies, and lead technology transfer efforts across Lumen's portfolio.

This position is a strong fit for someone who brings deep scientific expertise, thrives on independently driving complex technical initiatives, and excels in a highly cross-functional environment. You will collaborate closely with Manufacturing and R&D teams to ensure alignment and successful program execution, clearly communicate scientific strategy, risks, data interpretations, and recommendations to project teams, leadership, and internal and external partners. You will also author technical reports, protocols, and presentations, execute assigned milestones on time while upholding high scientific standards. You will also have the opportunity to supervise and mentor junior team members.

Lumen’s breakthrough biologics manufacturing and administration platform addresses critical challenges from patient accessibility to global climate change. The Process Development Scientist II will lead development, optimization, and qualification of scale-down models (SDM) for upstream and downstream processes supporting complex biologics. This role is central to advancing robust process understanding, enabling efficient technology transfer, and will have the opportunity to contribute to Lumen’s innovative platform manufacturing process.

If you are a resourceful, detail-oriented scientist with sound judgement, strong organizational skills, and the ability to manage multiple priorities while delivering high-quality results in a fast-paced and evolving environment, we encourage you to apply.

Duties & Responsibilities:

This position requires working under the 21 CFR part 210/211 standard pharmaceutical cGXP quality system processes.

• Lead the development, optimization, troubleshooting, and qualification of scale-down models for upstream and downstream processes for complex biologics
• Design, execute, and analyze complex experimental studies using sound statistical and DoE methodologies
• Lead technology transfer efforts
• Timely execution of assigned milestones while maintaining high scientific standards
• Collaborate cross-functionally with Manufacturing and Research and Development teams to ensure alignment and successful program execution
• Clearly communicate scientific strategy, risks, data interpretations, and recommendations to project teams, leadership, and internal/external partners
• Maintain thorough and timely documentation in electronic laboratory notebooks and company systems
• Author technical reports, protocols, and presentations for internal and external audiences

Qualifications & Requirements:

• Education and Experience:
  • PhD or equivalent experience in phycology, plant biology, molecular biology, biochemistry, molecular biology, microbiology, chemistry, or related field
  • Minimum of five years’ experience with biochemistry, microbiology, or molecular biology
  • Demonstrated expertise with upstream or downstream process modeling for biologics
  • Experience with multi-factor Design-of-Experiments (DOE), data analysis, and troubleshooting skills
  • Experience culturing microorganisms at research, pilot, and commercial scale preferred
  • Hands-on experience or the desire to learn biochemical and immunoassays (ELISA, MSD, SDS-PAGE, western blot, etc.), spectroscopic or fluorescence-based techniques, or quantitative PCR protocols
• Skills and Attributes:
  • Excellent organizational skills with meticulous attention to detail
  • Ability to manage multiple priorities and deliver high-quality results on time
  • Resourceful with proven ability to lead, manage, and leverage internal and external resources to plan and resolve issues
  • Strong interpersonal and collaborative skills to promote team success
  • Effective written and verbal communication skills, including the ability to explain complex technical concepts clearly
  • Demonstrated integrity, sound scientific judgement, and professional ethics
  • Ability to work both independently and in a highly collaborative team environment

Physical Requirements:

• Ability to work on-site in Seattle, WA
• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 23 kg
• Perform delicate manual procedures in the laboratory.

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.

This position is on-site in Seattle, WA.

Join Lumen Bioscience as a QC Specialist, Microbiology to help establish and perform microbiological quality control testing that supports process development, manufacturing, and product release in an early-stage GMP environment. In this role, you will execute routine and non-routine microbiological assays, including bioburden testing, microbial limits per USP, and environmental monitoring, while helping maintain a compliant QC microbiology lab.

This position is a strong fit for someone who enjoys hands-on lab work and brings solid quality and compliance fundamentals. You will prepare media, reagents, and cultures, document results accurately using Good Documentation Practices, interpret results and trends, and escalate OOS, OOT, or atypical findings. You will also support method qualification and validation, equipment qualification, calibration, and maintenance, and contribute to quality systems by authoring and revising SOPs, test methods, and controlled documents. You will assist with deviation investigations, CAPAs, and change controls as needed, and partner closely with Process Development, Manufacturing, Quality Assurance, and external partners to support lot release and program timelines. If you are detail-oriented, organized, proactive, and comfortable building structure in an evolving environment, with a strong commitment to quality and compliance, we encourage you to apply.

Duties & Responsibilities:

This position requires working under the 21 CFR part 210/211 standard pharmaceutical cGXP quality system processes.

• Microbiology Testing & Analysis
  • Perform routine microbiological assays, including bioburden testing, microbial limits per USP, and environmental monitoring.
  • Conduct adventitious agent screening or support external testing as needed.
  • Prepare media, reagents, and microbiological cultures following SOPs and GMP requirements.
  • Document results accurately in compliance with Good Documentation Practices (GDP).
  • Interpret results, identify trends, and escalate out-of-specification (OOS), out-of-trend (OOT), or atypical findings.
• Quality Systems & Compliance
  • Author and revise SOPs, test methods, and other controlled documents.
  • Support qualification, calibration, and maintenance of microbiology laboratory equipment.
  • Participate in method qualification/validation and QC readiness for GMP manufacturing.
  • Assist with deviation investigations, CAPAs, and change controls as needed.
  • Ensure work is performed in compliance with cGMP, GLP, and company quality policies.
• Environmental Monitoring & Facility Support
  • Perform routine environmental monitoring.
  • Trend EM data and support investigation of excursions.
  • Coordinate sample submission to external contract testing labs when required.
• Cross-Functional Collaboration
  • Work closely with Process Development, Manufacturing, Quality Assurance, and external partners to support lot release and overall program timelines.
  • Provide microbiology subject matter insights to support risk assessments, contamination control strategy, and process improvements.

Qualifications & Requirements:

• Education and Experience:
  • Minimum 6 years of work experience in Quality Control in a regulated (cGXP) organization.
  • -OR- a PhD in biochemistry, microbiology, or related scientific field plus 2 years of hands-on microbiology experience in a pharmaceutical, biotech, or regulated laboratory environment.
  • -OR- a bachelor’s or master’s degree in biochemistry, microbiology or related scientific field plus 5 years of hands-on microbiology experience in a pharmaceutical, biotech, or regulated laboratory environment.
  • Knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records.
  • Operational experience with PCR-based methods (dPCR preferred; qPCR and RT-PCR helpful).
  • Operational experience with direct ELISA-based methods.
  • Strong leadership and mentoring experience.
• Skills and Attributes:
  • Hands-on, detail-oriented, and organized.
  • Strong communication skills across technical and non-technical teams.
  • Comfortable building structure in ambiguous or evolving environments.
  • Proactive problem-solver who enjoys continuous improvement.
  • High level of integrity and commitment to quality.
  • Experience supporting clinical-stage or commercial GMP operations.
  • Familiarity with method validation, equipment qualification, and QC lab setup.
  • Familiarity with the MSD platform.
  • Experience with regulatory inspections or QA/QC audits.
  • Ability to support weekend or off shift testing as needed in a startup environment.

Physical Requirements:

• Ability to work on-site in Seattle, WA
• Ability to sit/stand for extended periods of time (2 or more hours)
• Occasionally lift or carry up to 23 kg

Benefits at Lumen Bioscience:

• Stock bonus
• Health, Dental, and Vision premiums fully covered by Lumen
• 401k match up to 4%
• Industry-leading PTO policy, paid refresh days, and paid year-end holiday office closure
• Monthly wellness program to support your health and well-being
• Free onsite parking or public transportation subsidies
• Comprehensive parental leave policies
• Life insurance, short & long-term disability, and access to employee assistance programs

At Lumen Bioscience, we foster a workplace built on collaboration, innovation, and professional growth. This role offers a significant opportunity to contribute directly to cutting-edge biotechnology and the advancement of global health solutions.

Join us to shape innovative solutions and drive operational excellence.