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Performs professional, technical laboratory functions.
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
The Mfg Operator BC performs all the general duties and operations to manufacture the product. An operator will operate machines and handle components using prescribed standard operating procedures and cGMP guidelines to manufacture and ensure the product meets the quality requirements. The operator will complete the necessary documentation and records to maintain quality control.
We are seeking an undergraduate or graduate student in life sciences who is interested in applying pharmacokinetics/pharmacodynamics and translational science in drug development. This individual will work in our Clinical Pharmacology Department and will support the group in the decision-making for advancing molecules through critical stages of development. During the internship, she/he will be assigned an interesting and stimulating project and will get hands-on experience in clinical pharmacology. She/he will be included in the group’s strategic meetings as well as in cross-functional team meetings and will have a chance to present her/his work on several occasions during the duration of the internship.
Undergraduate or Graduate student in a Science discipline. This individual will work in our Regulatory Affairs Department, supporting the Regulatory Strategy group. He/she will be assigned interesting and challenging projects related to competitive data research, precedent analysis, regulatory environment monitoring and ad hoc projects. Additionally, the intern will have an opportunity to learn from and work with other functions within Product Development, such as Pharmacovigilance, Clinical Development and Medical Affairs to work on ad hoc projects and understand the roles of these functions within pharmaceutical industry. For this internship opportunity, we are looking for a bright, curious individual, with excellent work ethic, strong attention to detail and a passion to learn about the industry. Ideally, the candidate will have a strong interest in learning about Regulatory Affairs or is, perhaps contemplating a career in Regulatory Affairs within the pharmaceutical industry. Effective written and oral communication skills are important, along with the ability to interact successfully with your supervisor and associates in varied areas of expertise. This will be a rewarding internship experience and great learning opportunity.
Along with your curriculum vitae, please also provide your responses to the Intern Program (IP) application questions. You must be available for the entire internship period (summer and no more than 90 days) and not have conflicting commitments (i.e. rotations, other employment) during that time.
Relocation and housing costs will not be reimbursed.
Directs and coordinates the packaging and or cartooning operation in accordance with Noven Pharmaceuticals Inc. SOPs and cGMP standards. The Lead Manufacturing Operator will set up, operate and change over packaging and or cartooning production equipment on the shift to which they are assigned. An LMO will assure that quality and documentation standards are maintained to ensure product compliance.
Provide technical support to manufacturing, engineering and other departments / teams by ensuring maximum equipment uptime, and addressing technical challenges. When not supporting manufacturing, technician shall perform scheduled PMs in timely manner as required by the CMMS system for work orders. Lastly, under limited supervision, performs and documents moderately complex technical functions relating to test, layout, quality control, fabrication, modification and assembly of mechanical equipment and/or components.
Responsible for the support of manufacturing processes, instrumentation and equipment from manufacturing values steam. Integral part of the value stream team accountable for delivery of improvements in the areas of safety, quality, service and cost per the team goals and metrics. Provides expertise in engineering, design, process and/or scale-up. Assists manufacturing operation in problem solving with regards to materials, components, equipment and systems. Develops and recommends new process solutions and technologies to achieve cost effectiveness and improved product quality. Recommends process improvements for the production of therapeutic products using tankage, piping, coating /oven systems, laminating dies, pouching machines, printing, bar code, vision and packaging systems.
Establishes operating equipment specifications and improves manufacturing techniques. Involved in new product scale-up, process optimization, technology transfer, design of experiments, as well as process validation activities. Interfaces with appropriate departments to ensure processes and designs are compatible for new product technology transfer and to establish future process and equipment automation technology. May lead process improvement team (s) consisting of production personnel and technicians.
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
The Strategic Engagement Liaison will be responsible for developing medical and scientific engagement strategies and implementation of plans for engagement with prioritized professional organizations, medical societies, and KOLs. The role will be responsible for overseeing the rollout of old and new KOL engagement activities
As a member of the Product Development team, the Strategic Engagement Liaison will develop an overarching strategy and ways of working for external engagements. This role will partner with medical affairs, product development and parent company to ensure agile and compliant execution of activities
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
This role’s primary responsibility is to become the Serialization Site Lead. Will serve as a hands-on SME to multiple Operations and IT processes and work with Engineering, Manufacturing, Quality, and IT in the optimization of processes and cost reduction initiatives. This position will also play an important role in helping to foster a culture of sustainable change through the creation and embedding of LEAN methodology and its supporting framework to deliver business transformation. The role must comply with Security, Environmental Health and Safety, and cGMP policies and regulations required by the job function.
Performs and documents the packaging operations for pharmaceutical products in accordance with Noven Pharmaceuticals Inc. SOPs and cGMPs. Works closely with cell team to identify and reduce waste in processes to optimize efficiencies and drive down operating expenses.
Performs and documents the packaging operations for pharmaceutical products in accordance with Noven Pharmaceuticals Inc. SOPs and cGMPs. Works closely with cell team to identify and reduce waste in processes to optimize efficiencies and drive down operating expenses.
Responsible for overall activities related to manufacturing and packaging of potential and existing products. Operate and maintain small production equipment. Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities. Maintain records and cleanliness in compliance with cGMP, SOP, and Safety protocols.
The Senior Clinical Research Manager will be responsible for independently providing operational oversight of the planning, implementation, and close-out ofanalgesic drug clinical trials.
As our leader in Senior Clinical Research Manager, this position will be responsible for the scientific and clinical strategy of assigned clinical trials. The Senior Clinical Research Manager will understand the details of the clinical trial protocols and is able to provide appropriate instructions to CROs and study personnel (i.e. CRAs)
Senior Clinical Research Manager will report to Chief Clinical and Regulatory Affairs Officer.