Kelly Services Sr. Analytical R&D Scientist - St. Petersburg, FL in St Petersburg, Florida
Analytical R & D Scientist
Analytical Research & Development Scientist - St. Petersburg FL
Kelly Services is currently seeking a Research & Development Scientist for one of our top clients in St. Petersburg FL.
The Analytical Research and Development (AR&D) laboratory supports evaluation and testing of raw materials, excipients, APIs, in-process and finished product samples. AR&D also performs development and validation of methods used to support release and stability testing of non-commercial products and materials. The department provides analytical services to manufacturing, process development, validation and new material qualifications. AR&D interacts with clients to provide not only research and testing of products, but also support CMC development activities in support of client regulatory filings. Activities are performed in accordance with specifications, standard operating procedures, approved test methods and/or protocols, regulatory requirements, and Quality departmental policies.
Candidates MUST Have:
PhD in scientific field with 1 yr, or MS in scientific field with 3+ yrs, or BS in scientific filed with 5 yrs in an analytical GMP environment
Minimum of 5 yrs experience with identification or separation techniques such as HPLC, UPLC, GC, MS, NMR and experience with method development/validation.
Requires cleaning validation experience.
Familiar with drug development and regulatory requirements for submissions.
Experience with common pharmaceutical laboratory equipment including, but not limited to UV/Vis, IR, AA, HPLC, UPLC, GC, ICP-OES, LCMS, ICP-MS, Dissolution
Expertise in wet chemistry techniques such as titrations, extractions and digestions
Critical thinking ability with experience in laboratory investigations.
5 years relevant pharmaceutical laboratory/analytical experience.
Sound foundation of ICH and USP/EP guidance.
Job Duties :
Develop and validation methods with some supervision.
Run routine test methods in support of drug substance and drug product sample testing as required.
Analyze data, document results, maintain laboratory notebook according to cGMP and Internal guidelines.
Communicate results in written and oral presentations.
Perform critical data review for method transfers and generation of stability reports to support regulatory filings.
Assist with data generation or compilation for regulatory inquiries, customer request and investigations.
Assist in writing Procedures, Specifications and Test Methods. Keep abreast of literature in field; help train colleagues; contribute to continuous improvement within the group.
Comply with FDA, EPA and OSHA regulations, performing all work in a safe manner. Maintain proper records in accordance with all SOP's and policies
Ability to develop and validate instrumental methods in support of Drug Substances and Drug Products Programs
Analysis of finished products, in-process materials, fill moisture, raw materials, cleaning verification and validation samples according to specifications, methods and protocols.
Preparation of reagents, standards and media needed for analysis according to procedures.
Safe handling of potent and teratogenic compounds.
Disposal of hazardous waste according to environmental regulations and company procedures.
Tabulation/ interpretation of results of analysis as recorded in notebooks, reports and logbooks.
Assures right-first-time execution of departmental methods and SOPs.
Audits and verifies results, including but not limited to, calculations in notebooks/logbooks and results in reports to check for accuracy and integrity of data.
Writes/ reviews analytical methods, deviations, protocols, SOPs and other technical documents.
Lead all analytical method transfer activities as required by their area.
Supports Material Evaluation Process for new materials
Provides project support for new product development programs under the direction of the lead scientist or group leader
Conducts and writes laboratory investigations using the appropriate Root Cause Analysis tools.
Identifies/implements improvements that will reduce cycle time for testing/release products.
Works flexible hours including weekends and evenings to accommodate the production / validation schedule.
If you are interested in advancing your career with this opportunity, apply now for immediate consideration.
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world
a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect
with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.
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