What are the responsibilities and job description for the Analytical Scientist I position at TekWissen LLC?
Job Description
Job Description
Overview :
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. 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 :
The Analytical Scientist I performs extensive laboratory work to support specialized software-based stability studies
The Analytical Scientist I, with minimum supervision, ensures all tests are completed on time, results are accurate, and all activities are documented.
The Analytical Scientist I effectively present the results in the AD meetings.
REQUIREMENTS / PREFERENCES
Education Requirement(s) :
A bachelor's degree in science, or international equivalent, with 3 years of proven Pharmaceutical Analytical Laboratory experience.
A Master's degree or higher in Science, or international equivalent, with 2 years of proven Pharmaceutical Analytical Laboratory experience.
POSITION DUTIES & RESPONSIBILITIES
Performs extensive laboratory work to support the specialized software-based stability studies for the determination of shelf-life of the drug product
Write SOPs / guidelines / OI / reports related to the stability studies, specialized stability software and any other as needed.
Must be able to perform the Assay method, Impurities method and dissolution method for the drug products
Accurately and timely documents the experiments and results into the notebooks, ELN and LIMS (if required)
With minimum supervision, manages projects to ensure all tests are completed on time, results are accurate, and all activities are documented.
Effectively communicates to all stakeholders the analytical activities and findings.
Follows SOPs / OIs and analytical laboratory practices to ensure the work quality and compliance
Interacts with analysts on the data review to recommend appropriate corrections / modifications / improvements needed to build consistency with respect to documentation practice guideline
Perform other duties as assigned.
SKILL & COMPETENCY REQUIREMENTS :
Must have a minimum of 2 year experience in the QC or R&D in pharmaceutical industry
Must have Hands-on experience with Waters & Agilent HPLC / UPLC and dissolution apparatus (USP Type 1 and 2)
Understands fundamental analytical chemistry and chromatography.
Able to quickly learn specialized-stability studies software
Able to troubleshoot testing and / or analytical method related issues.
Understands and follows GMP / SOP requirements
Familiar with analytical laboratory documentation practices
Hands-on experience in using Waters Empower3 software would be a plus but not compulsory.
Expertise in MS Office, such as Word, Excel, and PowerPoint.
Good communication and interpersonal skills
This individual must be highly motivated, have a positive "can-do" attitude and the ability to work in a fast-paced environment as a collaborative team player
Practical knowledge and experience with application of analytical method development and method validation activities.
Preferences :
Go the extra mile to get things done at high quality
Ownership of the work
TekWisen Group is an equal opportunity employer supporting workforce diversity.
