Danaher Corporation Project Leader, Custom Consumables in Westborough, Massachusetts
Help us improve access to life-changing therapies that can transform human health
We are Cytiva, a global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics. Formerly part of GE Healthcare, we have a rich heritage tracing back hundreds of years, and a fresh beginning since 2020.
Our customers undertake life-saving activities. These range from fundamental biological research to developing innovative vaccines, biologic drugs, and novel cell and gene therapies. Our job is to supply the tools and services - the pots, pans, soups and sauces - they need to work better, faster and safer, leading to better patient outcomes.
We are looking for a R&D Project Leader to lead our Custom Consumable Engineering Team located at the our Westborough, MA site. You will be accountable for directing activities of an engineering team which is responsible for an extensive portfolio of custom consumable products. You will interface with Product Managers and the Commercial Team to add to the product portfolio. You will delegate each project, establish and track project milestones, hold team accountable for deliverables, provide status reports to key stake holders, provide technical guidance to the team, and participate in definition of technical requirements and risk management. You will generate performance metrics, identify opportunity for improvement, and implement updates to process and methodology to improve performance. Provide inputs on resource requirements, business risks, and equipment required to achieve project goals. Ensure clarity on scope and deliverables for the products you will be responsible for. Does this sound like your passion? Then we would love to hear from you.
What you’ll do
Works collaboratively with Product Management and Commercial Team to develop Custom Consumable products for Cytiva Customers.
Maintains project backlog tracker of 40+ consumable products to track workflow priority, task status, ownership, milestone progress, project delivery dates, and performance metrics.
Uses project tracker to generate performance metrics, identify performance trends, identify process gaps/challenges, and implement process/methodology improvements.
Provides technical guidance to and directs high level activity of engineering team. Identifies challenges for product verification and guides engineers to potential solutions. Obtains status reports from engineers, tracks progress and holds them accountable for deliverables.
Has strong knowledge and understanding of document control, design transfer, verification, validation, acceptance activity, DMR, DHR and electronic signature requirements to ensure that product, equipment, tools, processes, software, training and documentation meet requirements
Participates in workflow scoping, aids in design of verification phase activities, reviews and approves technical documentation including drawings and reports, and electronic change control.
Manages R&D resources to maintain the Business expectations while coordinating with site and business functions for needed support and ensure early engagement with the cross-functional team on planning and scoping.
Maintains clear communication to the customer through commercial team. Provides commercial team with updates to project status and deliverable dates.
Works with commercial team and product management to identify multiple solutions for customer needs. Discriminates solutions to provide the most expedient variant that meets the needs of the customer.
Works in partnership with the Global Supply Chain Team as well as other functions including Sales and Operational Planning, Material Leadership, Business Team Leaders, Facilities Leader, Planners, Buyers, Production Team Leaders, and Logistics and Distribution Specialists. Develops a communication plan that will ensure seamless communication with the Project Team, Project Steering Committee, and the indirect stake holders. Works with SMEs and Project Management Leaders on all Project Change Orders, deviations, Scope, specification and timeline changes. Works with Finance, Leadership, and Op Ex Team to manage budget changes.
Works with Quality Assurance and Regulatory to ensure all requirements and regulations are met.Complies with Company Quality Management System, Policies, Goals, and applicable laws and regulations as they apply to this job type/position. Identifies and reports any quality or compliance concerns and take immediate corrective action as required.
Who you are
Bachelor of Science degree in either; Mechanical Engineering, Systems Engineering, BioEngineering, Biomedical Engineering, Chemical Engineering or Plastics Engineering.
Minimum of 5 years relevant experience in Bioprocessing, Medical Device, or related Biotechnology field or regulated manufacturing industry with demonstrated leadership of cross-functional project teams and an ability execute high visibility projects with high expectations.
Has strong knowledge of product development for consumable products in the pharmaceutical or medical device industries.
Fluent in CAD systems; SolidWorks, Pro/ENGINEER or CREO using PDM/PLM systems.
Working knowledge of plastic material characteristics, particularly as used in disposable medical devices, or life science or biomedical products.
Knowledge of biocompatible material selection for sterile single-use applications in bioprocessing and/or medical device applications.
Awareness of GMP and governmental regulations related to drug manufacturing sufficient to appreciate the need for documentation accuracy.
Ability to read and interpret professional journals and technical procedures, write test protocols and reports; communicate test analysis and results.
Proficient with Microsoft tools; Word, Excel, Power Point, Project and Visio.
Hands-on experience designing, prototyping and testing of components and assemblies.
Excellent communication and influencing skills and ability to gain buy-in for initiatives.
Master’s degree in either; Mechanical Engineering, Systems Engineering, BioEngineering, Biomedical Engineering, Chemical Engineering or Plastics Engineering.
Proficient with MS Project to create Project Plans, Work Breakdown Structures (WBS) and Gantt chart schedules.
Proficient with relevant regulatory and Q/A guidelines governing single-use plastic components such as Biocompatibility requirements per USP Class VI and ISO-10993.
Six Sigma Certification (Green Belt, Black Belt) or knowledge of DFSS.
Experience working in an Agile work environment.
Application of Risk Management methodologies to aid in meeting commitments
Who we are
Whatever your role, we bring purpose and challenge into our everyday work. If you are driven to make the world a better place thanks to science and medicine, you’ll feel right at home here. If you’re flexible, curious and relentless, you’ll belong. If you are excited about a global culture, this can be the place to further your career.
Want to know more? Experience life at Cytiva on our Careers website, Instagram channel and LinkedIn page!
Cytiva is a 3.3 billion USD global life sciences leader with nearly 7000 associates across 40 countries who are dedicated to our mission to advance and accelerate therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings efficiencies to research and manufacturing workflows, ensuring the development, manufacture and delivery of transformative medicines to patients.
Cytiva is part of the Danaher family of companies, a global science and technology innovator committed to helping customers solve complex challenges and improving quality of life around the world.
Danaher Corporation and all Danaher Companies are equal opportunity employers that evaluate qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. The “EEO is the Law” poster is available here.
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