Jobs at KBI Biopharma

Manages cGMP-controlled electronic and paper documentation throughout its lifecycle, including issuance, review, approval, archival, retrieval, and destruction. Processes records in EDMS, issues manufacturing documents, maintains controlled forms and logbooks, coordinates review workflows, manages off-site storage, fulfills documentation requests, and supports audits, inspections, and client inquiries. Ensures document accuracy, integrity, accessibility, and compliance with GMP and company requirements.

The Senior Project Manager oversees the project portfolio for a biopharmaceutical commercial manufacturing facility. Responsibilities include tracking major GxP, capital, process improvement, technology transfer, new product introduction, and operational readiness projects; leading strategic initiatives; supporting portfolio governance; and improving project management practices through coaching, training, and standardization. The role also requires collaboration with site leadership and management of project budgets, processes, and cross-functional stakeholders.

Performs GMP testing, product release and stability testing, analytical method transfers, and method qualification and validation for biopharmaceutical products. Reviews experimental data, troubleshoots analytical procedures, prepares regulatory-quality documentation and client reports, and maintains expertise in cGMP requirements, scientific literature, instrumentation, and analytical techniques including chromatography, electrophoresis, immunoassays, and biophysical methods.

Designs, manages, and supports LAN/WAN, wireless, SD-WAN, and IT/OT segmented network infrastructure across laboratory, manufacturing, and corporate environments. Configures switches, routers, and firewalls; troubleshoots connectivity issues; supports network security measures; monitors network performance; and documents technical procedures, configurations, and project plans. Requires strong routing, switching, VPN, IPv6, cloud, virtualization, and network security knowledge, plus a bachelor’s degree and at least three years of experience.

Supports SAP S/4HANA implementation, enhancement, integration, and stability across Finance and Supply Chain processes, including Record-to-Report, Order-to-Cash, and Procure-to-Pay. Coordinates SAP Ariba, Concur, and third-party integrations; contributes to Agile delivery, testing, configuration, validation, cutover, and backlog management. Partners with business, IT, and QA stakeholders while maintaining compliance with FDA, GxP, SOX, CSV, 21 CFR Part 11, and GAMP 5 requirements.

Manages MRO inventory, cycle counting, spare parts, asset bills of materials, and CMMS data. Plans maintenance and calibration work orders, documents materials and lot traceability, supports SAP integration, and assists with equipment installations. Coordinates vendors, quotes, purchase requisitions, pest control, pipette calibration, utility walks, and work-order closure. The role requires accurate documentation, cGMP knowledge, inventory management, and collaboration with engineering and maintenance teams in an onsite biopharmaceutical facility.

Supports SAP S/4HANA supply chain processes across manufacturing, planning, warehousing, inventory, quality, and procurement. Responsibilities include functional configuration, implementation enhancements, testing, UAT, cutover, issue resolution, system integrations, and Agile delivery. The role supports SAP integrations with Ariba, MES, LIMS, and 3PL systems while maintaining CSV documentation, audit readiness, and FDA, GxP, and SOX compliance in a regulated pharmaceutical environment.

Designs, develops, configures, and supports GxP-regulated enterprise Quality applications in a biopharmaceutical environment. Leads architecture, compliance, data integrity, security, troubleshooting, disaster recovery, lifecycle planning, and continuous improvement. Translates quality and business requirements into scalable solutions, ensures audit readiness, and provides technical mentoring without direct people management responsibilities.

Leads analysis, design, validation, implementation, and continuous improvement of regulated Quality Systems in a biopharmaceutical environment. Translates Quality and regulatory requirements into system solutions, supports audits and inspections, manages system lifecycles, and drives automation, integration, data governance, and reporting. Serves as a senior advisor to Quality leadership, leads complex global initiatives, facilitates cross-functional workshops, and mentors junior analysts.

Leads the global Environmental, Health, Safety, and Sustainability program across multiple biologic manufacturing sites. Directs compliance, incident response and investigations, environmental permits, risk management, sustainability initiatives, metrics, audits, hazardous waste and wastewater programs. Develops governance, procedures, engineering controls, training, budgets, and EHS&S resources while partnering with operations, regulators, clients, auditors, and contracted service providers.

Conduct and oversee protein analytics by LC-MS and related techniques for biotherapeutic development, regulatory submissions, and commercialization. Design analytical experiments and strategies, review method development and validation data, prepare regulatory-quality documentation, advise clients and leadership, manage project milestones, and mentor junior scientists. Serve as a mass spectrometry subject matter expert while collaborating with process development, characterization, and regulatory teams.

Supports downstream bioprocess development through experiment execution, data analysis, technical documentation, technology evaluation, scheduling, equipment troubleshooting, maintenance, and laboratory organization. The role contributes to process improvements, efficiency, and performance guarantees while meeting client deadlines and supporting flexible downstream operations.

Performs analytical testing for biopharmaceutical manufacturing, including in-process, product release, stability, and cGMP testing. Supports stability trending, troubleshooting, laboratory investigations, method and protocol review, technical reporting, and accurate documentation. Interprets experimental data, contributes to project goals, ensures compliance with safety procedures, and supports quality activities in a contract development and manufacturing environment.

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.

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.

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.

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.

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.