Sr Chemist

• Advanced degree in chemistry or chemical engineering or related technical field;
• 5+ years of experience in R&D within medical device or pharmaceutical industries;
• Experience with new product development and sustaining project support;
• Expertise in combination device analytical test method development and validation: HPLC, GC, dissolution, bioassay ;
• Formulation and testing experience with adhesives, cyanoacrylates preferred;
• Expertise with analytical instrumentation, including troubleshooting: dissolution USP Apparatuses, HPLC-DAD, GPC, GC-FID/MS, Karl Fischer, FT-IR and UV-Vis;
• Strong problem-solving capabilities;
• Solid oral and written communication skills;
• Ability to manage and prioritize multiple tasks and lead projects ;
• Experience in moderate and complex data analyses using statistical techniques;
• Experience of using chromatography software: Empower and MassHunter;
• Experience using common electronic documentation software (e.g. MAP, Agile or equivalent).

Design, develop and provide technical expertise in the research and development (R&D) of medical devices from conception to market release.

This role is an individual contributor within the Peripheral Vascular Health operating unit, which employs the full breadth of our talent, technologies, products, services, and solutions to address the needs of customers and patients across the globe. We focus on transforming global vascular disease management.

The Sr. Chemist will apply fundamental chemistry principles to develop and validate new, safe and effective products treating the unmet needs of patients suffering from venous disease. Responsibilities include providing support to new product development and sustaining engineering teams, as well as performing testing and analysis on medical devices for improvement and cost reduction. This position requires collaborative interaction within the Research and Development team and with Manufacturing and Quality functions to achieve business deliverables.

A Day in A Life
As a R&D Sr. Chemist you will focus on supporting R&D initiatives to new therapies and changes to the commercial product while adhering to policies using specialized knowledge and skills. The role requires effective collaboration, management and prioritization of multiple concurrent tasks in an ambiguous environment. Responsibilities may include the following and other duties may be assigned:

• Work independently under limited supervision on larger, moderately complex projects / assignments or lead small projects / processes;
• Perform sample preparations and testing using various analytical equipment;
• Operate and troubleshoot analytical equipment;
• Lead and/or participate in the development and qualification of new analytical instrumentation and automation technologies;
• Lead and/or perform analytical test method development and validation;
• Lead and/or perform studies on process characterization, optimization and validation;
• Perform statistical data analyses of acquired data;
• Author protocols, reports and presentations of analytical and interpretative nature.
• Communicate results to a broader audience;
• Act as a mentor to colleagues or direct the work of other lower level professional. Provide guidance, coaching and training to other employees within job area;
• If needed, perform day-to-day activities in the R&D analytical laboratory, including inventory, supply ordering, instrument maintenance, and lab safety practice implementation;
• Make improvements of processes, systems or products to enhance performance of the job area.
• Develop strong partnerships and work effectively with cross-functional team members;
• Perform job functions in accordance with applicable GMP, GLP and ISO standards;
• Comply with applicable FDA and international regulatory laws and standards;
• Maintain required documentation per GDP procedures.

Must Have – Minimum Qualifications
Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience.

Nice to Have

• Advanced degree in chemistry or chemical engineering or related technical field;
• 5+ years of experience in R&D within medical device or pharmaceutical industries;
• Experience with new product development and sustaining project support;
• Expertise in combination device analytical test method development and validation: HPLC, GC, dissolution, bioassay ;
• Formulation and testing experience with adhesives, cyanoacrylates preferred;
• Expertise with analytical instrumentation, including troubleshooting: dissolution USP Apparatuses, HPLC-DAD, GPC, GC-FID/MS, Karl Fischer, FT-IR and UV-Vis;
• Strong problem-solving capabilities;
• Solid oral and written communication skills;
• Ability to manage and prioritize multiple tasks and lead projects ;
• Experience in moderate and complex data analyses using statistical techniques;
• Experience of using chromatography software: Empower and MassHunter;
• Experience using common electronic documentation software (e.g. MAP, Agile or equivalent).