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Sr. Chemist Technical Services - Huntsville
Location: AL - Huntsville
Position ID: P0003798
Senior Chemist, Technical Services
This position will be responsible for improving quality control processes, evaluating test methods, addressing supplier related material issues, and evaluating technology enhancements. The incumbent will provide analytical trouble-shooting and technical support to commercial product testing, and liase with Analytical Research and Development regarding method development and transfer activities.
The principle activities are directed at providing services to the commercial QC operation in order to support process excellence and to becoming a key focal point in QA/QC processes by working with plant personnel to ensure the business quality targets are met.
* Recommends improvements to existing analytical test methods, for reasons of consistency, efficiency, robustness, and compliance.
* Interacts with Analytical R&D to ensure method suitability supporting scale-up activities from pilot to full scale production.
* Primary resource for methods development support for the R&D new products development program – method suitability, transfer, troubleshooting.
* Interact with raw material suppliers to investigate material related issue.
* Support new supplier qualification requirements, including specification development.
* Provide technical expertise, as necessary, to support laboratory investigations.
* Evaluate new technologies to improve laboratory efficiency and compliance.
Skills:(Proficiency in manual, verbal or mental manipulation of data or things e.g. specific software skill, data manipulation skills such as modeling
* Demonstrated hands-on analytical testing experience.
* Demonstratedability to write technical documents such as SOPs, protocols and test methods.
* Strong communications skills both verbal and written.Education/experience:(The minimal acceptable level of education, work experience, and certifications necessary for employment, e.g. advanced degree on chemistry, previous work experience on drug development)
* Bachelor’s degree in Chemistry or related field with 7 - 10 years of relevant experience
* Master’s degree or higher with 3 to 5 years of experience preferred.
* Experience in analytical methods development in a plant environment with demonstrated skills to trouble shoot day to day challenges.
Abilities:(Abilities as evidenced through activities or behaviors that are similar to those required on the job, including Endo-wide competencies, mission critical segment competencies, and functional/job specific competencies, e.g. dealing with ambiguity, action oriented, self-development, and decision quality)
* Ability to trouble shoot day to day challenges in the laboratory, such as those encountered with methods.
* Ability to work in cross functional teams, i.e. QA, Regulatory, etc. when needed.
* Ability to effectively perform knowledge transfer on technical matters to QC or other departments as necessary.
* Strong ability to work in a self-directed manner with little supervision.
* Ability to evaluate new technologies for use in existing laboratories.
* Ability to suggest to and implement method improvements and enhancements.
* Capable of evaluating data in order to theorize likely outcomes within a given set of parameters.
Knowledge:(Proficiency in a body of information that can be applied directly to accomplish a task, e.g. knowledge of pain therapy, knowledge of particular drugs)
* Strong knowledge and understanding of regulatory methods. Ability to successfully analyze finished goods, APIs and excipients used in the generics division.
* Strong knowledge of techniques and equipment used in pharmaceutical laboratories.
Some knowledge of statistics including determining minimum data points in order to achieve statistically relevant results.
Qualitest is an equal opportunity employer.