Reagent NPI Manager

SUMMARY:

The role is within the Reagent Development department releasing Dye-Antibody Conjugates to an offsite Reagent Operations facility. The main purpose of this role is the successful introduction of a portfolio of new products into manufacturing assets, ensuring that both customer and company expectations are met. The NPI Manager provides project management leadership and is responsible for project progress against specific milestones and timelines. The job also requires the provision of forecasts of medium-term resource requirements against anticipated project needs and production of plans for deployment of staff or changes to plant configuration and equipment as appropriate to meet objectives. A good knowledge of GMP, Health Safety & Environment and associated operational issues are required; The jobholder will take a lead role in calculating product introduction resources and costs in consideration of these technical factors together with commercial needs. They will be accountable as part of the manufacturing team for delivery of custom reagents. Projects contain technical development, analytical services, GMP manufacturing and new process introduction of a range of antibody dye conjugates.

The successful candidate will ideally have a degree in biology, chemistry, or chemical engineering together with a minimum of 3 years' experience in the reagent industry. Key skills and competencies include communication, influencing and organizational skills together with the ability and enthusiasm to drive projects to conclusion. Ideally the candidates will have some prior experience in project management, manufacturing management or technical support. The jobholder will need to think creatively and apply new and innovative techniques to bring business benefits.

It is essential to have the ability to work within a cross-functional project team to deliver against sales commitments and timelines. This role requires managing and aligning resources to deliver the manufacture of dye-conjugated antibody material within the agreed project timelines, directing project activities, tracking project status, and serving as the manufacturing point of contact relating to project status and progression. The position requires the ability to co-ordinate and influence multi-disciplinary project teams meeting standards in both a development and a GMP environment, with demonstrated skills and abilities in critical thinking, problem solving, detail and results orientation, managing multiple and sometimes competing priorities and excellent verbal and written communication.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Co-ordinates a project team of technical and scientific team members from R&D, Manufacture, marketing and QA to deliver against reagent project commitments and timelines.
• Assesses the scope of delivering new processes and creates a detailed timeline outlining actions, deliverables and risks.
• Identifies and requests resources, including technical and scientific resources required to execute the project from functional areas (i.e. operations, R&D, quality, marketing, etc.).
• With the manufacturing coordinator reviews the new process proposal scope and project schedule with the project team to identify gaps, risks and additional proposed services that may be required to successfully execute the project.
• Co-ordinates with reagent R&D and manufacture to develop new reagent manufacture and QC work instructions
• Works with the Manufacturing coordinator ensure smooth transfer of reagent product manufacturing and QC process.
• Create BOMs for new reagent products in the database
• Work with marketing on new product pricing
• Maintain accurate reagent product information in the database
• Work with R&D, manufacture and QC to periodically review the reagent product development process to ensure adherence to ISO13485
• Maintains accurate timelines and open actions using tools such as MS Project, MS Excel, tracks and manages ISO13485 and GMP compliance via approved systems.
• Ensures timely completion and compliance with GMP and all other relevant company training requirements.
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EXPERIENCE AND QUALIFICATIONS:

• 3 plus years of related pharmaceutical or biotech experience required.
• Previous experience of working in ISO13485, GMP reagent manufacture.
• Experience in IVD reagent product development and manufacture transfer is a plus.
• BS required, MS, or PhD degree educated in science or engineering preferred- or equivalent experience from pharmaceutical / life sciences background.
• Knowledge and experience in the new reagent product process transfer are required.
• Strong knowledge of ISO13485 and GMP reagent manufacturing ideally within fluorescent labeled antibody reagents.
• Highly organized person with demonstrated capability in planning and project management, planning execution of teams, resources, procurement, materials, equipment qualifications etc.
• Project management training and or experience in lean manufacturing applications an advantage
• We also require candidates to be competent with IT systems, and in particular Microsoft Office including Outlook, PowerPoint, Word and Excel.

PHYSICAL DEMANDS AND WORK ENVIRONMENT:

• Candidates will be required to be able to lift 25lbs without harm, be able to work in a standing position for an hour at a time and be able to position their body without additional support to work on laboratory benches and obtain access to chemicals and other items on shelves.

Cytek is an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, gender identity, sexual orientation, national origin, genetic information, disability status, veteran status, or any other characteristic protected by law.