Danaher Corporation Senior Material Scientist in Marlborough, Massachusetts
Be part of something altogether life-changing!
Working at Cytiva in the Life Sciences industry means being at the forefront of providing new solutions to transform human health. Our incredible customers undertake life-saving activities ranging from fundamental biological research to developing innovative vaccines, new medicines, and cell and gene therapies.
At Cytiva you will be able to continuously improve yourself and us – working on challenges that truly matter with people that care for each other, our customers, and their patients. With associates across 40 countries, Cytiva is a place where every day is a learning opportunity – so you can grow your career and expand your skills in the long term.
Cytiva is proud to work alongside a community of nine fellow Danaher Life Sciences companies. Together, we’re pioneering the future of science and medicine, developing products that enable researchers in the fight to save lives.
We are looking for a Senior Material Scientist to work with our expert Cell and Gene Therapy Disposable R&D team of 30 employees across the world. Do you have a passion for Cell and Gene Therapy? Then we would love to hear from you.
What you’ll do
Manage various projects in the context of both Legacy Products and New Product Introduction (NPI) for Verification & Validation (V&V) and Validation Guide (VG) activities: - Materials' regulatory compliance assessments, including: REACH Regulation, BSE/TSE (Animal Origin), Latex-free and other material-related requirements (e.g. melamine, nitrosamine, PFOA, microplastic, etc.) - Biological Evaluation of all devices, including Biocompatibility and Extractable & Leachable (E&L) assessments (ISO 10993). - Sterilization and Shelf-Life assessments.
Lead cross-functional and multi-sites (e.g. USA, Europe, India sites) projects involving R&D functions (Applications, Biology), Regulatory Affairs (RA), Quality Assurance (QA), Manufacturing and Supply Chain.
Collaborate with Contract Manufacturing Organization - (CMOs) / Suppliers securing supporting documentation for materials and manufacturing processes to comply with standards, regulations and requirements.
Communicate and report on progresses, challenges and solutions.
Report assessments and supporting documentation in our data management system.
Support R&D team in selection of materials and assessment for fitness of use in intended applications.
Lead research activities related to identification, evaluation, and implementation of state of the art or novel material solutions for CGT disposable products.
Support Design Transfer Engineers with materials expertise in the development of ordinary and/or novel manufacturing processes.
Who you are
Master degree in Material/Polymer Science, Material/Polymer Engineering, Biomedical Engineering, Biology Engineering or equivalent professional experience.
Minimum 8-10 year-experience in regulated industry (e.g. medical device and/or pharma), including ISO 13485 and ISO 14971.
Knowledge of polymer materials, chemistry and manufacturing processes associated with medical devices and/or biological applications.
Strong organizational and communication skills
Highly motivated, independent, perseverant, detail-oriented and well-organized personality, with the ability to collaborate and operate in a multinational environment.
Considered as an asset: Doctorate degree with relevant experience with Medical Device submission to authorities (FDA, CE marking), Drug/Device combination products, REACH, BSE/TSE (Animal Origin), ISO 10993; Latex/Melamine/Nitrosamine-free requirements. Prior experience with Sterilization and aging/stability/shelf-life validation.
Potential previous position, relevant for this role and responsibilities: Sr. Polymer Scientist, Sr. Material Engineer, Sr. Verification & Validation Engineer, Sr. RA Specialist.
When you join us, you’ll also be joining Danaher’s global organization, where 69,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.
Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law. We value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.The EEO posters are available here (https://www.dol.gov/agencies/ofccp/posters) .We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at firstname.lastname@example.org to request accommodation. If you’ve ever wondered what’s within you, there’s no better time to find out.