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Biotech Operations Manager Jobs in Bothell, WA (NOW HIRING)

The Experience With operations spanning the globe and featuring a multi-cultural team, PSC Biotech ... Direct industry, client-facing experience in an engineering or project management role within ...

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Biotech Operations Manager information

See Bothell, WA salary details

$34.7K

$70.9K

$132.5K

How much do biotech operations manager jobs pay per year?

As of May 30, 2026, the average yearly pay for biotech operations manager in Bothell, WA is $70,937.00, according to ZipRecruiter salary data. Most workers in this role earn between $45,800.00 and $86,600.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Biotech Operations Manager, and why are they important?

To thrive as a Biotech Operations Manager, you need a solid background in life sciences, business management, and regulatory compliance, often supported by a relevant degree and industry experience. Familiarity with laboratory information management systems (LIMS), Good Manufacturing Practices (GMP), and project management tools is typically required, along with certifications like Six Sigma or PMP being advantageous. Strong leadership, problem-solving abilities, and effective communication are crucial soft skills for managing teams and cross-functional projects. These skills ensure efficient operations, regulatory adherence, and successful product delivery in the highly regulated biotech industry.

What are some common challenges faced by Biotech Operations Managers, and how can they be addressed?

Biotech Operations Managers often face challenges such as maintaining regulatory compliance, managing cross-functional teams, and ensuring smooth production processes. These challenges can be addressed by staying updated on industry regulations, fostering clear communication between departments, and implementing robust quality control systems. Additionally, leveraging project management tools and continuous process improvement strategies can help streamline operations and minimize risks.

What does a Biotech Operations Manager do?

A Biotech Operations Manager is responsible for overseeing the daily operations of biotechnology facilities, ensuring that production processes run efficiently and comply with industry regulations. They manage teams, coordinate schedules, oversee supply chains, and implement quality control measures. Additionally, they work closely with research and development, regulatory, and quality assurance teams to ensure products meet all safety and efficacy standards. Their role is crucial in maintaining productivity, safety, and compliance in a biotech organization.

What is the difference between Biotech Operations Manager vs Biotech Laboratory Supervisor?

AspectBiotech Operations ManagerBiotech Laboratory Supervisor
CredentialsBachelor's or Master's in Life Sciences, Business, or related fields; experience in biotech operationsBachelor's or Master's in Life Sciences; laboratory management experience; relevant certifications often preferred
Work EnvironmentOversees multiple departments, manages projects, and ensures compliance across operationsManages daily lab activities, supervises lab staff, and maintains lab safety and procedures
Employer & Industry UsageUsed in biotech companies for operational oversightCommon in research labs, biotech firms, and pharmaceutical companies for lab management

The Biotech Operations Manager focuses on overseeing overall biotech operations, including project management and compliance, while the Biotech Laboratory Supervisor concentrates on managing daily lab activities and staff. Both roles require relevant scientific credentials, but their scope and responsibilities differ significantly.

What are popular job titles related to Biotech Operations Manager jobs in Bothell, WA? For Biotech Operations Manager jobs in Bothell, WA, the most frequently searched job titles are:
What job categories do people searching Biotech Operations Manager jobs in Bothell, WA look for? The top searched job categories for Biotech Operations Manager jobs in Bothell, WA are:
What cities near Bothell, WA are hiring for Biotech Operations Manager jobs? Cities near Bothell, WA with the most Biotech Operations Manager job openings:
Pharmacovigilance Operations Manager

Pharmacovigilance Operations Manager

Immunome, Inc.

Bothell, WA โ€ข On-site

Full-time

Posted 7 days ago


Job description

Company Overview
Immunome is a clinical-stage targeted oncology company committed to developing first-in-class and best-in-class targeted cancer therapies. We are advancing an innovative portfolio of therapeutics, supported by a leadership team with deep experience in the design, development, and commercialization of cutting-edge therapies, including antibody-drug conjugates. Our pipeline includes varegacestat, an investigational gamma secretase inhibitor for which an NDA has been submitted to the U.S. FDA; IM-1021, a clinical-stage ROR1 ADC; IM-3050, an IND-cleared FAP-targeted radiotherapy; and IM-1617, an IND-cleared solid tumor ADC. We are also advancing a broad portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.
Position Overview
The Pharmacovigilance (PV) Operations Manager at Immunome is responsible for managing day-to-day global safety operations across Immunome's clinical stage oncology programs as well as commercial product(s). This role oversees case management activities conducted by external safety vendors, supports clinical study teams on safety matters, and ensures timely and compliant safety reporting in alignment with global regulatory requirements and Immunome's internal standards.
As a growing biotechnology organization, Immunome requires an adaptable and highly organized PV Operations Manager who can support cross functional communication, maintain inspection ready safety systems, and drive operational excellence across all PV workflows.
Responsibilities
Safety Case Management Oversight
  • Oversee safety case processing activities performed by Immunome's PV vendors, including AE/SAE intake, assessment, follow up, MedDRA coding, and regulatory submissions.
  • Ensure cases are processed within required timelines and maintain compliance with FDA, EMA, ICH, CIOMS, and other applicable regulations.
  • Validate case narratives, source documentation, and sponsor queries submitted by external partners.

Vendor & CRO Management
  • Serve as Immunome's point of contact for PV operations with contracted partners.
  • Monitor vendor performance through periodic metrics review, and compliance dashboards.
  • Coordinate operational clarifications and ensure prompt resolution of sponsor queries.

Compliance, Quality, & Inspection Readiness
  • Maintain continuous inspection readiness across all safety operations, ensuring complete, accurate, and audit ready documentation.
  • Support Health Authority inspections and internal/external audits, including document preparation, responses, and CAPA tracking.
  • Contribute to development, revision, and training of Immunome SOPs, work instructions, and PV governance documents.

Safety Systems & Data Management
  • Support data quality checks, reconciliation activities, and system updates.
  • Ensure robust data governance practices, including consistency, accuracy, and timely reconciliation with clinical databases.

Cross Functional Collaboration
  • Partner closely with Clinical Operations, Medical Monitoring, Regulatory Affairs, Quality Assurance, and Biometrics to support safety oversight across Immunome clinical programs.
  • Provide operational input into Safety Management Plans (SMPs), Safety Data Exchange Agreements (SDEA), and clinical study documents.
  • Support preparation of aggregate safety deliverables (e.g., DSURs, SUSAR listings, annual reports) through data coordination and operational QC.

Project & Documentation Management
  • Track PV milestones for multiple clinical programs and ensure timely sponsor review of safety documents (e.g., narratives, CIOMS/MedWatch forms).
  • Oversee documentation of operational decision making, vendor communications, and safety process deviations.
  • Facilitate safety-related communication with investigators/sites as needed.

Qualifications
  • Bachelor's or Master's degree in Life Sciences, Pharmacy, Nursing, or related scientific field.
  • Advanced scientific or clinical degree preferred.
  • A minimum of 5+ years of experience in pharmacovigilance or drug safety, including 2+ years in safety operations leadership or vendor oversight.
  • Experience in clinical stage biotechnology or oncology programs preferred.
  • Strong background in safety databases (Argus, ArisGlobal, or equivalent) and global safety regulations.

Knowledge and Skills
  • Deep understanding of PV operations, PV workflows, case processing, MedDRA coding, and regulatory timelines.
  • Strong organizational, analytical, and vendor management skills.
  • Ability to thrive in a fastmoving biotech environment with evolving pipelines and processes.
  • Excellent communication skills with the ability to collaborate cross functionally and represent PV during internal and external meetings.
  • Commitment to patient safety and scientific integrity.
  • Strong problem solving and critical thinking.
  • Adaptability within a growing, innovative biotech environment.
  • High attention to detail and operational rigor.
  • Team-oriented and proactive communicator.

Washington State Pay Range
$138,310-$169,890 USD
E/E/O
Immunome, Inc. is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
E-Verify
Immunome, Inc. is a participant in E-Verify. Please review the following notices: E-Verify Participation Poster | Right to Work Poster (English) | Right to Work Poster (Spanish).