Founded in 1999, Dexcom, Inc. (NASDAQ: DXCM), develops and markets Continuous Glucose Monitoring (CGM) systems for ambulatory use by people with diabetes and by healthcare providers for the treatment of people with diabetes. The company is the leader in transforming diabetes care and management by providing CGM technology to help patients and healthcare professionals better manage diabetes. Since the company's inception, Dexcom has focused on better outcomes for patients, caregivers, and clinicians by delivering solutions that are best in class - while empowering the community to take control of diabetes. Dexcom reported expected full-year 2021 revenues of $2.48B, a growth of 27% over 2020. Headquartered in San Diego, California, with additional offices in the Americas, Europe, and Asia Pacific, the company employs over 6,000 people worldwide.
Highly skilled Analytical Scientist with expert level experience in analytical method develop, method validation, specification development, analytical instrumentation maintenance, repair and troubleshooting and timely problem solving. In particular: Extractables and Leachables (E&L)
experience and polymer experience are sought after.
Someone who is proactive in driving innovation, works well independently and understands the importance and strength of the team. Knowledge and awareness to medical product life cycle and applicable rules and regulations is a plus.
Essential Duties and Responsibilities:
- Design, develop and validate analytical test methods: the buildout of Analytical Services at Dexcom.
- This position will require the writing of protocols and validation implementation using Dexcom QMS systems.
- The position is hands-on with a high level of chromatography expertise: HPLC, GC (Agilent) and GPC (Malvern) needed
- Ideally someone with mass spectrometry experience, in particular HPLC-QToF
- Understands polymer characterization and can run MDSC, TGA, TMA, Rheometers, Viscometers and Instron
- LIMs experience and comfort in looking at databases and trending data
- Lead the ideation, experiment design, execution, interpretation, and drive for scientific conclusion and decision to meet the targeted project goals and business objectives
- Work with cross-functional teams to solicit input and feedback as well as providing advice on raw material supply, biocompatibility, safety, scalability and other operation related design inputs and consultation.
- Estimates work schedule, communicates progress and issues to management
- Follows team standards and mentoring of junior staff
- Related experience in R&D or manufacturing with an emphasis on the biotech or medical device industry
- Must be knowledgeable of analytical techniques, polymer structure-properties relationship, synthesis and analytical instrumentation
- Must be familiar with instrument troubleshooting and repair,
- Mass spectrometry understanding needed: MSn and fragmentation
- Ideally expertise in Chromatography: HPLC and GPC's: Agilent systems and Malvern Omisolv. Able to run sequences and process data.
Experience and Education
- Bachelor's Degree is required, degree in Analytical Chemistry is preferred with a Material Science or Polymer Chemistry degree a plus
- Typically requires a Bachelors degree in a technical discipline, and a minimum of 5-8 years related experience or Masters degree and 2-5 years equivalent industry experience or a PhD and 0-2 years experience.
Provides technical expertise to the design and development of new invasive and noninvasive medical device product(s). Investigates/evaluates existing technology and advises research and development, regulatory affairs, and reliability engineering to ensure appropriate process development under the best possible conditions. Designs and implements new methodologies, materials, machines, processes, or products. Develops new concepts from initial design to market release. Conducts feasibility studies of the design to determine ability to function as intended. Maintains detailed documentation throughout all phases of research and development. Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services needed to meet scheduled timelines.Functional/Business Knowledge
- Possesses broad understanding of technical principles and theories. Ability to synthesize external data and research findings for application that may impact technical objectives.
- Demonstrates successes in technical proficiency and independent thought. Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
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- Exercises good judgment in selecting methods and techniques for obtaining solutions.
- Normally receives little instruction on day-to-day work, general instructions on new assignments.