Kelly Services Senior Analytical Scientist- West Caldwell NJ 07006 in West Caldwell, New Jersey
Analytical Senior Scientist- West Caldwell, NJ 07006
Required: Must have 10 years of experience in the following:
HPLC, GC, UPLC, dissolution, Empower, TotalChrom
Troubleshooting analytical instrumentation: HPLC, GC, UPLC, Dissolution
ICH guidelines, cGMP and GDP
Method development and method validation
FDA audit, investigations and write protocols as well as reports
Technical transfer experience
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
Independently develops, evaluates and validates analytical methods for assay of bulk drugs, raw materials, intermediates, and finished dosage forms using analytical instrumentation such as HPLC, UPLC, GC, GC/Headspace, dissolution, disintegration, spectroscopic and titrimetric techniques. Troubleshoots method challenges that arise under minimal supervision.
Strong demonstrated experience with Empower, TotalChrom and other chromatographic software packages.
Writes protocols and reports for method validation/ transfer GMP studies. Strong knowledge of ICH Guidelines.
Records, evaluates, interprets and summarizes technical data independently. Presents the result of his/her work internally and externally, and writes reports that will be submitted to the FDA and other regulatory agencies world-wide.
Conducts all activities in compliance with established regulatory requirements.
Has a strong knowledge and understanding of Good Documentation Practices. Contemporaneously documents activities in technical notebooks or validated approved electronic media.
Prepares reports, memos or regulatory documents.
Provides technical expertise in support of project timelines to ensure expectations are clear and customer requirements (internal and external) are achieved, in full an on time.
Assesses appropriateness of technology and their introduction to the laboratories.
Minimum requirements: B.A. or B.S. in analytical chemistry with at least 10 years of educational or on-the-job relevant experience in method development and validation in the pharmaceutical industry.
A good knowledge of cGMP regulations, ICH guidelines, and compendial methods is required. Incumbent must possess detailed knowledge of separation sciences and modern analytical instruments, and must be able to work with others to accomplish project goals.
Proven hands-on and autonomous while also able to work collaboratively.
Demonstrated strong analytical thinking ability and scientific curiosity.
Shown as quality focused, well-organized, detail oriented and timeline driven.
Demonstrated excellent written and verbal communication skills.
Proven team oriented and cooperative with others.
Strong adherence to safety, compliance, quality and timelines.
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 11,000 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 2016 was $5.3 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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm