Job Profile Summary
Branchburg is the molecular diagnostics manufacturing engine within Global Operations and a Polymerase Chain Reaction (PCR) center of excellence. As the largest DIA manufacturing site in North America, our teams deliver a broad portfolio of PCR-based in-vitro diagnostic tests. Our operations include reagent and active diagnostic ingredient (ADI) production, filling and packaging. Our 63-acre site with ~1400 people is currently under expansion, fueled by our culture of agility, innovation and transformation. Each day we focus on delivering the value of Roche Diagnostics to patients around the world
Perform and oversee production and production support duties for Operations and ensure quality of production by the department.
Performs a variety of duties relating to production operations. Follows departmental work instructions, SOP's, OSHA safety regulations and cGMPs to perform assigned tasks.
Monitor and oversee lab supply inventory, input production data and other work-output data into appropriate network (e.g. SAP / LIMS) and maintain documentation in accordance with established procedures.
Duties may include handling of hazardous materials in activities described above.
Perform direct manufacturing activities such as formulation of Oligo Reagents, enzyme Reagents, Oligo Pools, Liat's oligo solutions, Buffer solutions, and HPLC eluent solutions by following detailed instructions outlined in production batch records and SOPs.
Interface with internal groups to assure laboratory equipment maintenance, calibration and documents conform with established practices.
Attends required training classes and participates in on-the-job training.
Manages schedules, workload and establishes priorities using inputs from business requirements, SAP, and/or internal customer needs.
Participates in the design and organization of experiments in conjunction with supervisor. Providing input in writing experimental protocols, investigations and reports may be required. Serves as a resource to operations or scientific staff.
Provides input for improving existing laboratory procedures. Assist supervisor in development and implementation of new procedures and evaluating new products and equipment. Assist with generation of written standard operating procedures.
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