Jobs at KBI Biopharma

Supports and leads mammalian cell culture and harvest process development projects across shake flasks and multiple bioreactor scales. Responsibilities include bioreactor operation, sampling, feeding, process calculations, data analysis, documentation, statistical modeling, project planning, client presentations, technical reporting, and process transfer to cGMP manufacturing. The role also supports medium development, coaches junior staff, and requires weekend and holiday flexibility.

Implements and leads environmental, health, safety, and sustainability programs for a biologics manufacturing site. Responsibilities include incident response and investigations, regulatory compliance, environmental permits, inspections, risk mitigation, employee training, PPE assessment, waste management, emergency preparedness, audits, recordkeeping, and coordination with operations and management. The role represents the site during OSHA, EPA, DOL, client, and regulatory inspections and drives corrective and preventive actions.

Review process development and biopharmaceutical project data for accuracy, completeness, compliance, and proper documentation. Verify calculations, transcription of raw data, laboratory records, batch records, and final reports. Identify errors, add comments and edits, communicate corrections to stakeholders, route documents for further review, and confirm corrections are completed accurately. Projects involve monoclonal antibodies, recombinant proteins, peptides, and other biologics.

Conducts cGMP laboratory testing and analytical method development for biotherapeutic samples. Executes experiments using protein analytics techniques, analyzes and documents data, troubleshoots methods, prepares technical reports, presents findings, and supports safety, compliance, and continuous improvement activities.

Manages site QA oversight of deviations and CAPAs, including triage, investigation review, approvals, training, and process improvement. Leads and develops QA staff, coordinates cross-functional quality systems work, tracks metrics, supports manufacturing and batch release timelines, and manages client communications. Collaborates with global QA, supports audits and regulatory inspections, and ensures compliance with GMP and worldwide biotechnology-product regulations.

Leads site Quality Assurance and Quality Control for a biopharmaceutical contract manufacturer. Oversees GMP compliance, raw material and drug substance disposition, analytical and microbiology testing, deviations, CAPA, change control, validation, data integrity, audits, inspections, supplier quality, and quality metrics. Manages and develops Quality personnel, partners with operations and global stakeholders, establishes quality strategy, and maintains inspection readiness. Serves as the site’s final decision-maker for GMP compliance.

Lead MS&T operations for tech transfer, process validation, and support labs at the Durham manufacturing site. Manage multidisciplinary engineering and scientific teams, coordinate with Process Development, Quality, Supply Chain, Facilities and Manufacturing to enable successful clinical and commercial product introductions, ensure cGMP compliance, support PAI, drive standards and process scale-up, recruit and develop talent, and represent the department in audits and cross-functional leadership meetings.

Leads the Boulder site's Operational Excellence strategy and a global portfolio of Lean, Six Sigma, continuous improvement, and transformation initiatives. The role develops OpEx capabilities, coaches leaders, manages cross-functional projects, establishes performance metrics, drives process standardization, supports digital and AI-enabled improvements, and delivers measurable operational and financial results. This director also leads culture transformation, capability-building programs, risk management, reporting, and sustained adoption across a GMP-regulated biopharmaceutical environment.

Lead and execute downstream process development, characterization, and technology transfer for microbial processes. Design and run experiments for chromatography, TFF, and filtration unit operations, produce regulatory-quality documentation, support cGMP manufacturing and deviations, and implement downstream process improvements. Serve as technical SME and support training and safety compliance.

Leads downstream-focused technology transfer, process engineering ownership, and manufacturing facility support for biologics programs. Serves as a subject matter expert in drug substance operations, reviews technical and validation documents, develops solutions, supports 24/7 manufacturing operations, and coordinates cross-functional teams. The role also manages project resources, influences adjacent departments, and acts as a primary technical client contact.

Client-facing Quality Assurance specialist supporting pharmaceutical product release, deviation investigations, CAPA reviews, complaints, audits, inspection readiness, and cGMP compliance. Acts as the liaison between internal Quality teams and clients, leads quality activities for projects, communicates batch status and quality metrics, supports regulatory interactions, and completes Annual Product Quality Reviews. The role requires cross-functional collaboration, quality decision-making, and reporting across global networks.

Leads business development for biopharmaceutical services by identifying prospects, developing client relationships, soliciting and managing RFPs, presenting capabilities, coordinating technical visits, negotiating agreements, and closing contracts. Maintains CRM opportunities, supports strategic partnerships and collaborations, coordinates with scientific, legal, quality, marketing, and management teams, and monitors biopharmaceutical industry opportunities. Requires travel to client sites, company facilities, trade shows, and scientific meetings up to 50% of the time.

The Director of Business Development focuses on acquiring new biopharmaceutical clients and expanding existing relationships, negotiating contracts, attending trade shows, and ensuring strategic alignment to meet business objectives.

Lead QC microbiology programs including environmental, compressed gas, product testing, media release, and lab support. Oversee method verifications, troubleshooting, data analysis, documentation, regulatory compliance, training, and safety for laboratory operations. Provide technical leadership and may perform testing as needed.

This role involves identifying and developing biopharmaceutical business opportunities, managing client relationships, closing contracts, and coordinating business development activities.

Lead design and delivery of cloud-based, data-centric software platforms for biopharma. Develop, maintain, and review data analysis tools, work with SMEs, own projects end-to-end, mentor engineers, and promote best practices and digital transformation.

Perform and analyze bioassays (cell-based assays, ELISAs), run plate-reader and flow cytometry assays, maintain multiple cell lines aseptically, troubleshoot experiments, record data per cGMP/GLP/GCP, and communicate results in notebooks and presentations.

Execute bioanalytical tests (HPLC, SDS-PAGE, SDS-CGE, ELISA, UV-Vis) and basic biophysical characterization, perform elementary data analysis and troubleshooting, maintain lab and electronic notebooks, uphold instrument knowledge and lab safety, and contribute to contracted analytical projects under manager supervision.

Perform GMP testing, method transfer, qualification/validation, and data review for separations-focused analytical assays (HPLC, UPLC, CE-SDS, electrophoresis, immunoassays). Produce regulatory-grade documentation and client reports, troubleshoot experiments, maintain cGMP compliance, and stay current on instrumentation and scientific literature.

Perform and interpret bioassay data (cell-based assays, ELISAs), maintain cell lines, operate plate readers and flow cytometers, ensure cGMP/GLP/GCP-compliant documentation, troubleshoot experiments, and follow safety and regulatory practices.