EDUCATION, QUALIFICATIONS & EXPERIENCE:

• Minimum 10 years’ experience in a laboratory beyond college graduation required
• Bachelor of Science Degree in Chemistry, Chemical Engineering, or Material Science required
• Experience working in cross-functional team in a Regulated Medical Device Environment strongly preferred
• Familiar with Quality and Regulatory Systems for Medical Devices including Combination Drug Products (ISO 13485, 10993, and 21CFR Part 820 regulations) strongly preferred
• Strong analytical/problem-solving skills with demonstrated ability to collect, summarize and report technical information
• Strong computer skills with competency in MS Office (R, MiniTab, Word, PowerPoint, Excel, Outlook)
• Knowledge and experience with ISO 13485, GLP/GMP/GDP is highly desired
• Detail-oriented, highly organized team player
• Excellent verbal, written and interpersonal communication skills
• Self-starter and motivated individual who works independently

POSITION PURPOSE:

The primary responsibility of the Senior Scientist is primarily new combination product projects through proof of concept, experimental design for reliability, and concise documentation within the Business Units. Additionally, this position will apply their analytical expertise to support Production, R&D, validation and/or troubleshooting activities. The Senior Scientist should have a firm understanding of surface chemistry, organic and polymer chemistry, as well as contemporary chemical and polymer characterization and other analytical techniques, in order to help expand our understanding of combination devices and the reactions of coating with surfaces. To accomplish this, this position must be willing to use outside resources when necessary. The Senior Scientist will be required to apply sound scientific fundamentals and good documentation techniques to successfully achieve the needs of the Business Unit.
The Senior Scientist will be expected to work independently and as part of a team, perform assigned responsibilities with expediency, and commensurate with in-depth analysis, resulting in good understanding of the developed chemistry. This position will maintain clear and frequent communication with the direct supervisor. This position may also be expected to provide support to peripheral Business Units, as business needs require and permit. This may include technical support, experimentation, testing, validation support, report reviews and general troubleshooting. This job may involve supervising employees or not and reporting to the Business Unit Leader.

RESPONSIBILITIES:

• This position shall be committed to impartiality and confidentiality, including not allowing commercial, financial, or other pressures to compromise impartiality
• Lead highly technical teams primarily involving combination products
• Lead technical conversations with customers on highly technical projects
• Write Plans and Reports for projects as needed for technical projects
• Write budgets, plans, and schedules for each technical project
• Determine and report KPI and metrics for each project as determined by the BU Leader and the COO
• Lead/support/consult validation activities for equipment and/or processes
• Source equipment and materials as needed for projects
• Attend seminars, webinars, conferences to stay up to date on current technology and processes
• Meet with customers as required to support technical combination device project proposals
• Perform other duties as assigned