LanceSoft Inc
POSITION SUMMARY
The Scientist will perform qualitative and quantitative chemical analyses/experiments for the Analytical Development laboratory for developmental products. Participate in method validation/transfer/verification and review method validation protocols, reports, and SOPs. Perform basic pre-formulation study for various dosage forms.
ESSENTIAL FUNCTIONS
Track and review the project progress.
Identify and quantify all ingredients in a reference formulation to ensure cost effective formulation is achieved
Perform and evaluate study for pre- formulation of solids, solutions, suspensions, gels, ointments, creams, suppositories and sterile injectable dosage forms.
Transfer new analytical techniques from various clients.
Lead all routine analytical testing for In-process, release, stability and method validation/transfer/verification activity
Take a lead role for method development utilizing established scientific technique and automated instrumentation (UPLC, HPLC, GC, Dissolution, Auto titrate, Particle sizer etc.).
Lead out of specification investigation testing.
Write and review method development and investigation/deviation reports.
Ensure communications with all members of the team; respond professionally and in a timely fashion to internal and external customers
Thorough knowledge for various laboratory software usages
Other duties as assigned
POSITION QUALIFICATIONS
Analytical skills and knowledge of scientific protocols and complex scientific principles necessary to perform complex experiments and research on chemicals and medicines
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions
Research Skills - In-depth knowledge and expertise in developing new analytical method.
Ability to design and conduct a systematic, objective, and critical investigation.
Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.
Experience in method development, validation and transfer using chromatography (UPLC, HPLC, GC), Spectroscopy (IR & UV-Vis), Microscopy, and Wet Chemistry for sterile and non-sterile products.
Knowledge of ICH, FDA, and DEA regulations.
Advanced computer skills; ability to develop conclusions based on information from multiple sources.
Ability to lift up to 25 lbs.
Ability to handle hazardous waste, and lead safety programs for the laboratory.
May be required to wear personal protective equipment
EDUCATION
A minimum of a BS in analytical or pharmaceutical related field
A Master’s Degree in Chemistry, Pharmaceutical Science or a related Science field preferred but no required
EXPERIENCE
5 Years working in Analytical Development in sterile pharmaceutical environment.
Experienced in the critical analysis of complex molecules and method development/method validation etc.
Solid understanding of cGMP, GLP and GDP.
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ESSENTIAL FUNCTIONS
Track and review the project progress.
Identify and quantify all ingredients in a reference formulation to ensure cost effective formulation is achieved
Perform and evaluate study for pre- formulation of solids, solutions, suspensions, gels, ointments, creams, suppositories and sterile injectable dosage forms.
Transfer new analytical techniques from various clients.
Lead all routine analytical testing for In-process, release, stability and method validation/transfer/verification activity
Take a lead role for method development utilizing established scientific technique and automated instrumentation (UPLC, HPLC, GC, Dissolution, Auto titrate, Particle sizer etc.).
Lead out of specification investigation testing.
Write and review method development and investigation/deviation reports.
Ensure communications with all members of the team; respond professionally and in a timely fashion to internal and external customers
Thorough knowledge for various laboratory software usages
Other duties as assigned
POSITION QUALIFICATIONS
Analytical skills and knowledge of scientific protocols and complex scientific principles necessary to perform complex experiments and research on chemicals and medicines
Problem Solving - Ability to find a solution for or to deal proactively with work-related problems; ability to look beyond the standard solutions
Research Skills - In-depth knowledge and expertise in developing new analytical method.
Ability to design and conduct a systematic, objective, and critical investigation.
Good written and oral communication skills. Proficient in the ability to read/write and comprehend complex instructions, correspondence, and memos. Have the ability to effectively present information in a one-on-one or group situation.
Experience in method development, validation and transfer using chromatography (UPLC, HPLC, GC), Spectroscopy (IR & UV-Vis), Microscopy, and Wet Chemistry for sterile and non-sterile products.
Knowledge of ICH, FDA, and DEA regulations.
Advanced computer skills; ability to develop conclusions based on information from multiple sources.
Ability to lift up to 25 lbs.
Ability to handle hazardous waste, and lead safety programs for the laboratory.
May be required to wear personal protective equipment
EDUCATION
A minimum of a BS in analytical or pharmaceutical related field
A Master’s Degree in Chemistry, Pharmaceutical Science or a related Science field preferred but no required
EXPERIENCE
5 Years working in Analytical Development in sterile pharmaceutical environment.
Experienced in the critical analysis of complex molecules and method development/method validation etc.
Solid understanding of cGMP, GLP and GDP.
#J-18808-Ljbffr