FLSA Status: Exempt
Shift (include only if applicable)
The primary function of this position is to provide polymeric materials expertise and data to support the development of ICU products and to solve plant or customer originated polymeric materials concerns. Selection and qualification of materials will often determine whether or not a project is feasible. Without the correct material, the project cannot proceed, the product manufacturing process may be plagued with inefficiencies or the product may fail functionality. This can impact a wide range of project types, including cost reductions, raw material replacements, and new product development. This role will provide subject matter expertise and operate the laboratory to generate data in the area of polymer science for site Technical, Quality, Engineering and Operations leadership and technical teams to drive down to root cause of polymer film and plastic component manufacturing issues.
Essential Duties & Responsibilities:
• Maintain an ongoing search for new polymeric materials technologies which can be used in existing products for cost reductions or performance improvements or which may enable the development of new products. Where not satisfactory commercial plastic materials exist for specific applications, work with academic, external contract, industry and own expert knowledge to identify polymer chemistry solutions to challenges posed by internal commercial, operational, quality, or external regulatory requirements.
• Act as a liaison between ICU and a network of contract laboratories and academic contacts to ensure comprehensive exploration of viable scientific solutions to complex technical problems. Collect, analyze and interpret information, whether it be test data, published scientific papers and patents or raw material vendor-supplied information. Demonstrate the ability to absorb and reduce such information to practical actions and recommendations.
• Plan and conduct experiments to challenge physical and chemical performance of polymer films and plastic pharmaceutical containers when they are exposed to potentially stability indicating conditions (time, temperature, mechanical stress, chemical exposure, etc.).
• Provide polymer processing and scientific expertise to site Technical, Quality, Engineering and Operations leadership to aid in the development of a long term pharmaceutically relevant polymer manufacturing strategy.
• Communicate effectively (verbally and in writing) across disciplines and with internal and external stakeholders on technical polymer chemistry questions. Create and maintain an accessible library composed of consolidated organizational polymer knowledge and newly acquired and/or created intellectual content. Prepare polymeric materials-related patent disclosures.
• Plan, conduct and rigorously document experiments to develop novel polymer blends for pharmaceutical applications, refine the manufacturing process for existing products, reduce cost, or improve performance of existing polymeric materials. Maintain and direct Materials Characterization and Processing Laboratory, including accountability for safety, compliance with appropriate FDA and OSHA regulations, setting work priorities, and writing capital requests for instruments and equipment.
• Ensure that all applicable local, state and federal regulatory requirements are met during the course of development. Act as the SME on polymer science with internal and external regulatory representatives
• Screen existing and develop novel polymer bends for extruded pharmaceutical film applications.
• Interface with ICU corporate and site technical resources to leverage the advantages of their perspective and assure project conformance to applicable ICU standards, current best practices and Quality Standards.
• Maintain technical skills in the latest techniques for polymer science as applied to cGMP pharmaceutical container manufacturing.
• Provide feedback and support for site manufacturing, technical and engineering personnel.
• Provide experimental scientific theory support to root cause investigations involving polymer film or molded plastic products performance issues.
• Assist plant engineering and site technical teams to troubleshoot polymer film extrusion equipment in the manufacturing areas
• Maintain materials characterization and processing laboratory, including staff and equipment responsibilities.
• Work on special projects as they arise.
Knowledge, Skills & Qualifications:
• Demonstrated technical leadership and technical abilities, including working knowledge of modern polymer characterization techniques, laboratory equipment and methods.
• Demonstrated ability to communication complex topics in written and verbal formats to a variety of stakeholders, such as: Manufacturing, Operations Management, Engineering, Quality, Regulatory Affairs and Commercial
• Ability to write clearly, concisely, and persuasively in a professional environment.
• Ability to manage multiple projects and priorities simultaneously.
• Demonstrated effective complex problem solving skills.
• Ability to evaluate and select polymer testing equipment and instruments.
Education and Experience:
• PhD preferred. Field or Specialty: Chemical Engineer, Material Science, Polymer Science, Chemistry or equivalent with extensive expertise in polymer chemistry.
• Equivalent experience to a PhD level acceptable for highly experienced MS level candidates.
• Educational background: minimum of Master’s Degree in Chemical Engineering, Polymer Science, Polymer Engineering or Polymer Chemistry, with a strong preference for a PhD Degree in the same fields as above. A strong academic foundation in polymer technology is essential to the efficient execution of the duties and responsibilities of this position. The higher the level of specialized education, the more analytical and perceptive the incumbent can be in effectively addressing and solving assigned tasks.
• Product development engineer or scientist in a polymeric material-related position (minimum 7 years, preferably in a pharmaceutical/FDA-regulated environment). A solid working knowledge of FDA regulations with respect to development required.
• Product development engineer or scientist with project management responsibilities (minimum 2 years).
• Medical product development experience contained in the above (minimum 2 years).
• Must be at least 18 years of age
• Must pass pre-employment drug screen and background check
• Typically requires travel less than 5% of the time
Physical Requirements and Work Environment:
• Generally office and technical laboratory environment. Cleanroom and/or manufacturing environment to support field installations, startups, troubleshooting and training.
• Ability to work night, weekend and holiday hours as required by projects and by support for 24/7 operation.
• Will be exposed to some Radio Frequency radiation, high temperature polymer blends, some incidental chemical fume exposure, typical of a polymer laboratory environment.
We are an Equal Employment Opportunity Employer, Female/Minority/Veterans/Disabled/Sexual Orientation/Gender Identity.