Senior Analytical Development Chemist

Company: Kelly Scientific Resources ( Learn More )

General Information
US-DE-Wilmington
N/A
Graduate Degree
Full-Time
Not Specified
Not Specified
False
False
Job Description

Senior Analytical Development Chemist            The Senior Analytical Development Chemist works with a team of chemists and other scientists involved in analytical research and related activities to support developmental studies for new and generic drug products and will generate data/reports for regulatory submissions. This person also performs, coordinates and/or leads analytical method development/validation and release/stability testing of drug products to generate documents for regulatory submissions.  Job duties include developing/preparing protocols and detailed project working plans, conducting chemical tests as defined in protocols or test methods, processing and analysis of data, troubleshooting and problem solving, and drafting study reports.  The Senior Analytical Development Chemist should work with minimal direction from Management, independently manages technical projects, and provides coordination / direction to the work of other employees as assigned. 



Education/Experience Requirements

 M.S in Chemistry with a minimum of five years relevant experience in pharmaceutical or related industry; or B.S. in Chemistry with a minimum of seven year relevant experience in pharmaceutical or related industry.  Other requirements include:

  • Industrial experience in developing and validating chemical test methods for pharmaceutical and/or biotechnology products
  • HPLC (including reversed phase, ion exchange and size exclusion chromatography), GC, FTIR, UV/Vis, Electrophoresis, and other USP instrumental and Wet chemistry methods used in pharmaceutical and biotechnology  quality control
  • Demonstrated performance in leading technical projects and personnel
  • Demonstrated technical writing skills (protocols, reports)
  •                          Specific Job Requirements  

    1. Take part in the planning, implementation and successful completion of all assigned projects in a timely fashion ensuring consistent high quality and using innovative / novel approaches.  These projects may include but are not limited to: bulk drug characterization, developing quantitative specifications and test methods for bulk drugs, dosage forms, impurities/degradation products and related substances; technology transfers; stability indicating assays; planning & implementing stability programs on both bulk drugs and/or dosage forms as per FDA/ICH guidelines.  

    1. Perform analytical research to support developmental studies for the successful development of new and generic drugs/products and generate data/reports for use by the client pharmaceutical companies as a part of their regulatory submission, such as IND, NDA, ANDA. 

    1. Demonstrate the ability to successfully handle several projects simultaneously.

    1. Reviews lab notebooks and data generated by other team members. 

    1. Provide guidance to assigned technicians.

    1. Provides timely communication of experimental results to the Director on specific projects and if required interact with the clients/customers in a very professional, ethical and responsive manner.  

    1. Assist the Director with evaluating and implementing new technologies.

    1. Comply with all relevant CGMP regulations and guidelines during carrying out of assigned studies, data analysis, interpretation and proper documentation.

    1. Other projects or activities as assigned by Management.





    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.



    About Kelly 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.

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