KBI Biopharma
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The Senior Program Manager will oversee project teams, manage client relationships, ensure project timelines and budgets are met, and provide mentorship. Responsibilities include facilitating meetings, analyzing risks, and maintaining high-quality standards in project execution, while collaborating with cross-functional teams and managing financial aspects of projects.
The Senior Accountant is responsible for ensuring the accuracy and completeness of the company's financial statements. Responsibilities include performing monthly closing procedures, analyzing accrual transactions, collaborating with project managers on accounting issues, supporting tax compliance efforts, participating in process improvements, and working with auditors to provide documentation. Special projects and administrative tasks are also part of the role.
The Principal QA Specialist oversees the coordination and management of Deviations and CAPAs within the AFS department, ensuring compliance with GMP activities. This role involves reviewing and approving testing data, method qualifications, and laboratory investigations, collaborating closely with QA and testing groups.
The Senior QC Analyst position involves conducting analytical testing, ensuring compliance with regulatory standards, organizing and processing samples, performing method validation, and supporting laboratory investigations. The analyst also engages in trend analysis, updates SOPs, and leads or participates in continuous improvement projects, maintaining safety and regulatory readiness at all times.
The MS&T Engineer I will apply engineering principles to problem-solve and drive projects to completion, manage multiple projects, and support customer site visits, process data compilation, troubleshooting efforts, and assist in tech transfer programs. Strong communication and project management skills are essential.
Responsible for compliance review of biopharmaceutical development GMP data, including the review and approval of release, in-process, and stability test data, method qualifications, validations, and laboratory investigations and deviations.
The VP of Strategic Marketing will lead the marketing strategy development and execution to enhance brand visibility and drive growth. Responsibilities include overseeing marketing campaigns, collaborating with cross-functional teams, monitoring performance metrics, and managing the marketing team while ensuring compliance with regulations.
The Scientist II is responsible for supporting biopharmaceutical product characterization by performing mass spectrometry and various biochemical techniques. The role includes managing projects, mentoring junior staff, ensuring compliance with regulatory standards, and producing high-quality documentation while maintaining effective communication with clients and team collaboration.
The Research Associate I executes experimental protocols and performs data analysis in biopharmaceutical laboratories, testing drug substance and formulation samples using various bio-analytical techniques while ensuring proper safety and compliance standards.
Data collection and analysis, documentation, instrumentation maintenance, communication with colleagues, collaboration with teams, safety adherence, attention to detail, organization of space and materials.
The FP&A Analyst supports the FP&A department in financial planning activities, including budgeting, forecasts, and data analysis. This role collaborates with leadership on accuracy and efficiency in financial operations, requiring advanced Excel skills and experience with ERP systems. The analyst will also manage CapEx items and respond to ad-hoc requests for financial data.
Responsible for product characterization studies of biopharmaceutical products using protein mass spectrometry and biochemical techniques. The role involves planning, executing, reviewing, and documenting client work while ensuring good communication and adaptability to changing program priorities.
The Program Manager will oversee cross-functional teams to deliver project outputs on time and within budget, while ensuring quality results. Responsibilities include client relationship management, managing project timelines, facilitating team meetings, analyzing risks, and managing financial aspects of projects. The role demands strong leadership and the ability to motivate teams without direct authority.
The Senior Manager of Quality Assurance oversees the deviations, CAPA and complaints quality systems, managing a team while providing QA support and training. The role includes tracking quality metrics, leading investigations, developing training materials, and facilitating client communications regarding quality-related events.
The Senior Quality Assurance Specialist is responsible for overseeing the review and approval processes for Deviations, CAPAs, and Effectiveness Checks in compliance with cGMP requirements. This role involves collaboration with multiple departments to ensure timely resolution of compliance issues, development of training materials, metrics generation, and mentoring of junior staff.
The Financial Analyst will conduct financial analysis, support month-end close processes, perform account reconciliations, and handle billing issues. Responsibilities include preparing invoices, maintaining customer records, collaborating with accounting teams, and implementing ERP systems. The role requires reviewing billing data, generating reports, and providing customer service.
The MS&T Senior Engineer provides technical support for cGMP production, focusing on tech transfers, process engineering, and validation. This role also includes managing equipment systems and leading cross-functional teams to ensure compliance and successful execution of processes.
The In-Process Support Associate will conduct analytical support for biopharmaceutical processes, particularly focusing on in-process and release testing using bio-analytical techniques like HPLC and UV-Vis. Responsibilities include data analysis, troubleshooting, documentation upkeep, and adherence to safety procedures. The candidate must have a strong protein chemistry background and will be expected to be flexible with work hours as needed.
The Senior Proposal Development Manager writes and edits technical proposals and project plans for biopharmaceutical services, collaborating with various teams to define project scope, schedule, and costs. Responsibilities include reviewing client RFPs, developing proposals, ensuring accuracy, maintaining quality standards, meeting deadlines, and representing KBI's technical capabilities to clients.
The Sr. Manager of MES Operations will lead and manage technical guidance for the IT manufacturing systems team. Responsibilities include executing digital strategy for MES solutions, adhering to GMP regulations, managing resources, ensuring compliance with system lifecycle processes, and addressing issues effectively while communicating across all levels of management.