Scientific and Clinical Careers

Job Title

Scientific & Clinical Job Details

Analytical Development Chemist

Job Code: #543
Job Type: Direct Hire
Salary: $80,000.00 - $85,000.00/hour
Job Location: Oak Brook, IL
Posted 2 days ago

Job Description

JOB SUMMARY

The Analytical Development Chemist is responsible for developing analytical methods and improvement of existing methods, along with performing routine assay using modern instrumentation.  

 

ESSENTIAL JOB FUNCTIONS
  • Independently develops analytical methods for new products and new ingredients used in personal care products
  • Independently develops analytical methods to support applicable regulatory requirement for current products and ingredients 
  • Proficient with GC/MS Masshunter software and mass spectral interpretation along with structure elucidation of small organic molecules.
  • Method development and identification of trace level small molecules that may result from process impurities, degradation products, or metabolites using but not limited to mass spectrometry.
  • Maintain accurate and complete notebook records for all method developmental, validation, and investigational studies in accordance with SOPs and protocols.
  • Writes and/or reviews procedures, protocols, summary reports and specification documents needed to support product development efforts.
  • Provides wide scope of expertise to business team regarding analytical matters.
  • Plans, monitors and performs chemical and physical testing on formulas and packaging components of stability samples.
  • Plans, monitors and performs assay validation for new/modified methods and new products.
  • Participates on and/or leads cross functional teams within Quality and R & D for special projects.
  • Maintains all analytical instruments in proper condition, including the calibration of instruments on a pre-determined time interval.
  • Conducts technical literature searches.
  • Provides laboratory and instrument training to technicians and coordinates technicians work schedule, where appropriate.
  • Coordinates required departmental activities with other groups as needed.
  • Leads and performs troubleshooting on analytical matters.
  • Leads and is responsible for transferring technical documentation including assay methods, stability data summary reports and product analytical specifications of new products from pilot scale to full-up production.
  • Explores and recommends new technologies, instruments and materials, which may have application for the product line.
  • Develops and presents to the Manager, Analytical Development and Product Support matters requiring his/her decision.
  • Conducts the transition of new products from pilot scale to full-up production, including the development of specifications, procedures, and methodologies.
  • Keeps abreast of current trends, practices, developments and regulatory changes, which would impact products, procedures or packaging.
  • Ensures the maintenance and/or adherence to good laboratory practices and all safety regulations.
  • Creates, contributes and/or reviews Corporate SOPs and Departmental Guideline documents either independently or in conjunction with other departments.
  • Maintains the confidentiality of all data and easy accessibility of such records.
  • Provides technical knowledge in guiding other chemists in the Quality Laboratory.
  • In conjunction with Manager, Analytical Development and Product Support, coordinates contract labs for required outside studies including writing/reviewing protocols, data and reports.

ADDITIONAL RESPONSIBILITIES

  • Performs and assumes other duties and responsibilities, as may be required by the Manager, Analytical Development and Product Support and/or Quality Director.
  • Supports the Winner’s Circle and ISO processes.
EDUCATION AND EXPERIENCE
  • A B.S. in Chemistry or related discipline; or equivalent in training and experience.
  • The knowledge and skills required for this position are typically acquired in 5 to 7 years of experience in a pharmaceutical or related healthcare industry.

SKILLS AND ABILITIES

  • Strong background in theory and fundamentals of mass spectrometry and ionization methodologies for small organic molecules.
  • Extensive experience in characterization of small organic molecules, natural products, synthetic polymers by mass spectrometry along with a background in theoretical and experimental organic chemistry to propose the origin of unknown components.
  • Excellent oral and written communication skills; highly organized and efficient record keeping.
  • Ability to provide clear reports and scientific direction to management, colleagues and collaborators.
  • Must possess strong analytical skill and complex problem solving skills.
  • Experience with chromatographic (HPLC/GC) method development, validation, and transfer.
  • Experience with Mass Spectrometry structural characterization.
  • Ability to effectively coach and mentor other analytical chemists.
  • Good math aptitude.
  • Considerable interpersonal skills are required to interact with internal and external customers.
  • Strong verbal and written communication skills.
  • A broad understanding of physical and chemical properties of chemicals, OSHA regulations, FDA regulations, USP, and cGMP with ability of adhering/complying to very disciplined scientific procedures.
  • Willingness to accept other duties, as assigned.
  • Must be discreet with confidential information of which he/she has access.
  • Demonstrated proficiency in office and laboratory instrument software.
  • Must possess the ability to develop and maintain an effective working relationship with internal and external customers, function as a team player, accept constructive criticism from management and comply with Company policies

MENTAL AND PHYSICAL DEMANDS

  • Physical demands include standing up 75% of the time and a combination of sitting down, writing, analyzing and calculating 25% of the time.
  • Travel and overtime requirements are dependent upon departmental demands.

WORK ENVIRONMENT

  • Good working conditions, however, occasionally exposed to elements such as fumes and odors.
  • The daily schedule of a Development Chemist is comprised of working with chemicals 100% of the time.