Analytical Chemist - Job # 3016

Additional Information
  • Our Client offers an exceptional compensation package which will be commensurate on experience and great benefits and a growth opportunity.
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position located in Raleigh-Durham, NC. Our Client is a rapidly growing Biotechnology company located in Durham, NC.

Essential Duties and Responsibilities:

We are seeking a highly motivated and eager incumbent to fill the role of Analytical Chemist for our rapidly growing Client. This ideal incumbent will provide support to the corporate drug development and manufacturing programs. Candidate will work with highly motivated research and development scientists in a goal-oriented multi-project environment. The selected candidate will be responsible for providing analytical support to the R&D and Manufacturing functions.

Responsibilities include, but are not limited to:

  • Perform analytical chemistry research and development independently and in collaboration with others to develop analytical methodology, mainly release and stability-indicating HPLC methods, for testing small molecule drug candidates.
  • Generate analytical data for new and existing drug substance, drug product and prototype formulations under development.
  • Summarize investigative studies in reports and in oral presentations.
  • Review and assess stability data; designing studies to assess formulation stability and product packaging.
  • Develop analytical methods for intermediates as well as final drug substance and drug products. Lead validation of these methods according to applicable regulatory requirements such as cGMPs and ICH guidelines.
  • Review and provide analyses of data and documentation related to developing and validating testing methodology.
  • Support the transfer of analytical methods to external vendors and provide on-going support for analytical work conducted at external vendors.
  • Author relevant CMC analytical regulatory documentation.
  • Perform and schedule routine maintenance and troubleshoot problems with analytical laboratory equipment, in particular HPLC.
  • Research and order new laboratory equipment and related software.
  • Conduct work in compliance with cGMP, safety and regulatory requirements.
  • Provide analyses and evaluations of materials, products, and procedures at all stages of the development process (pre-clinical through commercial).

Key Skills/Desired Experience:

  • BA or BS in Chemistry or related discipline with 5+ years of relevant experience or MS in Chemistry or related discipline with 3+ years of relevant experience.
  • The successful candidate will have a BA, BS or MS in Chemistry, vision research, or related discipline and have a minimum of three years related work experience in a research institution or pharmaceutical industry.
  • Possess the ability to work in a fast-paced environment.
  • Interact with internal and external teams and be flexible in supporting either R&D or Manufacturing analytical needs.
  • Experience with ophthalmic and/or sterile drug products desired.
  • Experience with analytical methodology for both large and small molecules desired.
  • Standard physical demands; performing tasks in a laboratory, handling animals, sitting at desk, working at computer.
  • Standard laboratory and office environment.

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