Search the 33 jobs at KBI Biopharma

The Manufacturing Support Associate I/II is responsible for maintaining GMP manufacturing facilities, managing process waste, and supporting manufacturing operations. Key tasks include routine cleanings, preparing assembly for production, and ensuring cleanliness in the process waste area. Aseptic and Gowning Qualifications are mandatory, and the role operates under cGMP regulations.

The Research Associate II/Sr. Research Associate will support in-process testing and lab experiments for biopharmaceutical development. Responsibilities include conducting assays, maintaining laboratory equipment, performing data analysis, ensuring proper handling of chemicals, and maintaining a safe work environment. This role requires staying updated on scientific literature and following safety protocols.

The Scientist I will conduct analytical testing, develop and troubleshoot bio-analytical techniques, perform QC testing in a GMP environment, author and review documentation, and provide technical support for clinical manufacturing. The candidate should foster continuous improvement and mentor junior staff in GMP testing and method development.

The Sr QA Specialist is responsible for reviewing and approving biopharmaceutical development GMP data, including release and stability test data. They oversee method qualifications and validations, and handle laboratory investigations and deviations. This role requires extensive experience in QA within a cGMP regulated environment, along with solid analytical and communication skills.

The QA Specialist II is responsible for compliance review of Biopharmaceutical Development GMP data, including review and approval of release, in-process, and stability test data, method qualifications and validations, as well as laboratory investigations and deviations.

The Downstream MS&T Engineer II/III will lead technical transfer projects, support business decisions, perform facility fit activities, provide cGMP production support, and communicate process data to clients. The role also entails leading troubleshooting efforts and collaborating with external partners on strategic projects.

The Program Manager is responsible for client relationship management and business delivery for KBI Biopharma. They oversee project timelines, ensure compliance with quality standards, manage financial aspects, and foster cross-functional collaboration. The Associate Program Manager handles assigned clients/projects and aids in client communication.

The Process Engineer II will maintain, optimize, and troubleshoot manufacturing equipment at a biopharmaceutical facility, ensuring compliance with cGMP standards. Responsibilities include equipment management, deviation investigations, change management, and cross-functional collaboration to enhance equipment performance.

The Sr. Manager MES Operations will lead the implementation and management of manufacturing execution systems (MES) and other IT solutions in a regulated industry. Responsibilities include technical guidance, team management, Agile collaboration, and ensuring compliance with regulatory standards.

As a MS&T Senior Engineer, you will support cGMP production operations by ensuring efficient downstream processes, oversee technology transfers and validations, and act as the primary client liaison to meet regulatory standards. This role emphasizes collaboration with various teams to drive process improvements and maintain equipment systems.

The In-Process Support Associate conducts cGMP in-process analytical support through bio-analytical testing including HPLC and UV-Vis techniques. Responsibilities involve detailed observations, data analysis, documentation upkeep, and adherence to safety regulations. The role requires flexibility for testing needs during non-standard hours.

The Product Marketing Manager at KBI Biopharma is responsible for driving revenue growth through strategic and tactical initiatives. This role involves developing go-to-market content, managing sales tools, collaborating with teams to ensure accurate information, and monitoring market trends. The manager will also liaise with stakeholders globally to maintain consistent branding and messaging.

The Financial Analyst will perform financial analysis, assist with month-end close, manage billing and accounts receivable processes, conduct account reconciliations, and generate reports on billing activities. This role involves collaboration with project managers and maintaining accurate customer billing records, along with supporting audits and ERP system implementations.

The Scientist I in Downstream Process Development focuses on process development, characterization, and technology transfer for microbial processes to cGMP facilities. They design and execute laboratory experiments, maintain compliance with regulatory standards, produce high-quality documentation, and support manufacturing and safety protocols while leading teams in meeting project deliverables.

The Senior Program Manager oversees project management within the Program Management Office, ensuring timely project delivery, client relationship management, and business operations. They lead cross-functional teams, manage project risks, and uphold communication with clients while also guiding financial aspects of projects and contributing to PMO initiatives.

The Engineer I will support customer visits and tours, oversee technical transfer and process validation activities, compile process data, and assist in troubleshooting efforts. This role involves collaboration with external partners on strategic projects and requires excellent communication skills.

The Program Manager at KBI Biopharma is responsible for managing cross-functional teams to deliver project outputs on time and within budget. Key responsibilities include client relationship management, overseeing project timelines, financial management, and supporting process improvements while leading teams to achieve project objectives.

The QA Specialist I/II will ensure compliance of products and processes with quality standards and regulations, perform compliance reviews, author and approve Standard Operating Procedures, and support manufacturing changeover processes. They will work closely with other departments to resolve compliance issues and facilitate quality assurance activities.

Responsible for following experimental protocols in biopharmaceutical labs, performing data analysis, and maintaining adherence to safety procedures. The role requires technical discretion in experiments and updates on scientific literature.

The EHS&S Specialist III is responsible for implementing and managing the environmental, health, safety, and sustainability program, ensuring compliance and improvements. Key responsibilities include incident investigations, environmental permit management, risk assessments, and regulatory compliance support, as well as drafting relevant policies and procedures.