Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor Michigan that offers strategic talent solutions to our clients worldwide. This client is a German multinational Pharmaceutical and biotechnology company and one of the largest pharmaceutical companies in the world headquartered in Leverkusen and areas of business include pharmaceuticals; consumer healthcare products agricultural chemicals seeds and biotechnology products.
Job Title: Analytical Scientist I
Location: Morristown NJ 07962
Duration:12 Months
Job Type: Contract
Work Type: Onsite
POSITION SUMMARY:
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The Analytical Scientist I performs extensive laboratory work to support specialized softwarebased stability studies
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The Analytical Scientist I with minimum supervision ensures all tests are completed on time results are accurate and all activities are documented.
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The Analytical Scientist I effectively present the results in the AD meetings.
REQUIREMENTS/PREFERENCES
Education Requirement(s):
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A bachelors degree in science or international equivalent with 3 years of proven Pharmaceutical Analytical Laboratory experience.
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A Masters degree or higher in Science or international equivalent with 2 years of proven Pharmaceutical Analytical Laboratory experience.
POSITION DUTIES & RESPONSIBILITIES
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Performs extensive laboratory work to support the specialized softwarebased stability studies for the determination of shelflife of the drug product
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Write SOPs/guidelines/OI/reports related to the stability studies specialized stability software and any other as needed.
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Must be able to perform the Assay method Impurities method and dissolution method for the drug products
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Accurately and timely documents the experiments and results into the notebooks ELN and LIMS (if required)
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With minimum supervision manages projects to ensure all tests are completed on time results are accurate and all activities are documented.
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Effectively communicates to all stakeholders the analytical activities and findings.
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Follows SOPs/OIs and analytical laboratory practices to ensure the work quality and compliance
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Interacts with analysts on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline
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Perform other duties as assigned.
SKILL & COMPETENCY REQUIREMENTS:
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Must have a minimum of 2 year experience in the QC or R&D in pharmaceutical industry
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Must have Handson experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2)
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Understands fundamental analytical chemistry and chromatography.
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Able to quickly learn specializedstability studies software
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Able to troubleshoot testing and/or analytical method related issues.
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Understands and follows GMP / SOP requirements
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Familiar with analytical laboratory documentation practices
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Handson experience in using Waters Empower3 software would be a plus but not compulsory.
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Expertise in MS Office such as Word Excel and PowerPoint.
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Good communication and interpersonal skills
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This individual must be highly motivated have a positive cando attitude and the ability to work in a fastpaced environment as a collaborative team player
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Practical knowledge and experience with application of analytical method development and method validation activities.
Preferences:
TekWisen Group is an equal opportunity employer supporting workforce diversity.