Scientist II (Analytical Method Development)

Scientist II (Analytical Method Development)


Job ID: 9748582

Hollywood, FL, US

Scientific

Bachelors Degree

Full Time, Direct Hire

Experienced (Non-Manager)

On-site

Biotechnology/Pharmaceuticals

First Shift (Day)

Hollywood, FL, US

Experienced (Non-Manager)

Full Time, Direct Hire

Biotechnology/Pharmaceuticals

On-site

Scientific

Bachelors Degree

First Shift (Day)

Job details

Kelly Science is seeking a Scientist II for a growing company located in the Fort Lauderdale/Miami, FL area.
 
Salary: $100,000-125,000/year based on experience & a 10% target bonus
Shift: (Second) Monday-Friday 4pm-12:30am
Employment Type: Full Time; Direct Hire
** Relocation Assistance available for qualified candidates **
 
Job Responsibilities:
 

  • Providing scientific and technical leadership in selection and implementation of analytical techniques that may be suitable for the portfolio of projects.

  • Conducting laboratory activities towards development, verification, optimization, transfer, and validation of stage appropriate analytical methods.

  •  Drafting and reviewing scientific documents that are commensurate with the requirement of global regulatory authorities e.g., US FDA, EMA, MHRA.

  • Designing and conducting physico-chemical characterization studies with a focus on liquid chromatography (LC), spectroscopy, and aerosol performance techniques for orally inhaled and nasal drug products (OINDP) following cGMPs.

  • Leading evaluation and selection of raw materials (APIs, excipients, primary and secondary packaging material, device component material etc.); pre-formulation, formulation and process development studies for OINDPs following cGMPs, company EH&S and other relevant guidelines.

  • Analyzing and summarizes analytical data using advanced tools including statistical packages.

  • Drafting sections of regulatory dossiers.

  • Communicating data summaries, study observations and recommendations to Executive Management.

 
Qualifications:

  • Combination of the following education/experience:

    • PhD in Analytical Chemistry or a related scientific field with at least 3 years of industry experience performing method development utilizing HPLC and empower software.

    • Masters degree in Analytical Chemistry of a scientific related field with 5+ years of industry experience performing method development utilizing HPLC and empower software.

    •  Bachelors degree in Analytical Chemistry of a scientific related field with 8+ years of industry experience performing method development utilizing HPLC and empower software.


  • Extensive knowledge of chromatography and spectroscopy based analytical techniques including HPLC, GC, UV, FTIR.

  • Experience with technical writing of protocols, reports, and SOPs.

9748582

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