$100K — $150K *
The primary functions of this position are to provide chemistry expertise to support the research and development (R&D) of new ICU products and to solve plant or customer related concerns for products manufactured by ICU Medical. This will include designing and supervising studies related to analytical method development and validation for drug substances, drug products, and packaging systems; analytical investigations to solve technical issues encountered by R&D or commercial manufacturing; and stability studies for drug substances and drug products. This role will provide subject matter expertise in chemistry related topics for site Technical, Quality, Engineering and Operations leadership and technical teams.
Essential Duties & Responsibilities:
• Maintain an ongoing search for new chemistry technologies which can be used in existing products for cost reductions, performance improvements, or enable the development of new products. Work with academic, external contract, and industry to identify 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 stability studies to challenge chemical performance of aqueous formulated chemical solutions in plastic pharmaceutical containers when they are exposed to various storage conditions (time, temperature, mechanical stress, oxidation, etc.).
• Provide chemistry expertise to site Technical, Quality, Engineering and Operations leadership to aid in the development of a long-term pharmaceutical manufacturing strategy.
• Communicate effectively (verbally and in writing) across disciplines and with internal and external stakeholders on technical chemistry questions. Create and maintain an accessible library composed of consolidated organizational chemistry knowledge and newly acquired and/or created intellectual content. Prepare patent disclosures in the areas of product formulation and/or analytic chemistry testing.
• Plan, conduct and rigorously document experiments to develop novel product formulations or packaging for pharmaceutical applications of terminally sterilized solutions, refine the manufacturing process for existing products, reduce cost, or improve performance of existing products. Will lead a team of development scientists.
• Ensure that all applicable local, state and federal regulatory requirements are met during development. Act as the SME on fundamental chemistry questions with internal and external regulatory representatives.
• Characterize/evaluate existing APIs and analytical testing methods and evaluate potential new API candidates and develop novel testing methods.
• 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.
• Assess supplier changes to components used in ICU Medical products.
• Write and/or review regulatory submissions documenting drug substance and drug product studies or proposed protocols for developing/transferring products at ICU Medical.
Knowledge, Skills & Qualifications:
• Demonstrated technical leadership and technical abilities, including working knowledge of modern analytical chemistry 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.
• Ability to select, evaluate, and lead technical professionals in a development and technical support environment.
• Demonstrated effective complex problem-solving skills.
• Ability to evaluate and select contract chemistry testing laboratories.
• Understanding of regulatory requirements for drug substances and drug products as well as pharmaceutical development guidelines established in the USP, ICH guidelines, etc.
Education and Experience:
• Educational background: minimum of Master's Degree in Chemistry (Analytical, Inorganic, Organic), 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 scientist in an analytical chemistry 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 scientist with project management responsibilities (minimum 2 years).
• Pharmaceutical 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 incidental chemical fume exposure, typical of a chemistry laboratory environment.
Valid through: 7/17/2020
$80K — $100K
4 days ago