Applicants must be based in Boston, MA. Position Summary. Identifies, evaluates, develops and closes new customers and expands business at existing customers. Identifies and assists in progressing biopharmaceutical business opportunities including new scientific and strategic partnerships, collaborations, licensing opportunities, joint ventures and alliances. Establishes and implements appropriate development strategies to support business object...
Job Summary. The Sr. Manufacturing Associate I/II is responsible for the execution of Upstream or Downstream production activities for early and late-phase Cell Culture programs within a GMP environment. The Sr. Manufacturing Associate I/II must follow the instructions depicted in SR’s, EPR’s, BR’s, SOP’s and forms. Additionally, must ensure all work is conducted following Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and...
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary. This position will provide technical support activities for GMP Manufacturing Operations in a multi-product, large scale, biopharmace...
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This is a Data Reviewer position in Analytical and Formulation Sciences department reporting to Project Leader. Responsibilities: Per...
Position Summary. The MQA Supervisor/Senior Supervisor is responsible for leading the MQA batch record review team. Responsible for the review, approval and posting of manufacturing batch records, internal support records, and related client records. Supervisor level loads work across the group and coordinates the support for external client reviews and timely resolution of comments. They will collaborate directly with the MQA Floor Support and M...
Job Summary. Manage the QA Analytical function at the KBI Biopharma, Hamlin location, supporting analytical laboratory operations in a contract biopharmaceutical manufacturing organization. Responsible for review of certificates of analysis for both clinical and commercial programs. Works directly with AFS, QC and Microbiology laboratories to resolve lab investigations and other compliance issues in a timely manner. Communicates directly with cli...
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This individual will lead and direct all QA activities supporting Facility Engineering, Validation and IT in a contract manufacturing...
At KBI Biopharma, we are advancing science and accelerating breakthroughs. As a global leader in biopharmaceutical development and manufacturing, we empower life science companies to bring new medicines and vaccines to the world faster. Explore your potential at KBI, where innovation meets impact. Position Summary: This individual will direct microbiology activities at Patriot Park. Responsible for the development, maintenance and harmonization o...
Job Summary: The MQA Supervisor/Senior Supervisor is responsible for leading the MQA batch record review team. Responsible for the review, approval and posting of manufacturing batch records, internal support records, and related client records. Supervisor level loads work across the group and coordinates the support for external client reviews and timely resolution of comments. They will collaborate directly with the MQA Floor Support and Manufa...
Job Summary: Responsible for providing Quality Assurance support to Manufacturing Process Operations. Performs document review and approval of Master Batch Records, SOP’s and Technical Documents. Collaborate directly with MS&T and Manufacturing to support BOM review and approvals to meet timelines. Job Responsibilities: Supports BOM review, approval, and release within ERP system Reviews and approves Technical Documents associated with process va...
Job Description The Manufacturing Associate I will perform Upstream or Downstream production activities for early and late-phase Cell Culture programs in a GMP environment. Responsibilities include executing tasks per SOPs, batch records, and GMP/GDP/GLP standards, ensuring compliance and accuracy. The role involves various unit operations such as media/buffer preparation, bioreactor operations, aseptic techniques, chromatography, ultrafiltration...
