Job Description:
This position provides analytical support for cleaning verification activities and the testing of
materials in support of R&D activities and GMP manufacture of Drug Substance and Drug Product.
Analytical Techniques
HPLC
HPLC-MS
FTIR
KF
Conductivity
ICP
IC
GC
UV
pH
Wet Chemistry (USP)
Analytical Duties
Developing and qualifying (validating) analytical methods capable of detecting low levels
of residues on manufacturing equipment.
Perform swab/rinse sampling on manufacturing equipment in accordance to the qualified
method.
Perform analysis on cleaning verification samples to determine drug and detergent
residues.
Communicate analysis results to his/her supervisor and to the appropriate teams.
Support analysis of raw materials excipients packaging components starting materials
and packaged clinical supplies using various analytical techniques.
Residual Solvents testing by GC.
Routine Water Analysis by KF.
Compile new specifications for raw materials excipients and packaging components.
Assist in the testing of drug substance and drug products as needed.
Requirements
BS/BA in a relevant scientific discipline. Familiarization of analytical instruments making
buffers hands on experience with pH meter chromatography (HPLC and GC) and FTIR.
Detail-oriented and have good problem solving written and oral communication skills.
d
Job Description: This position provides analytical support for cleaning verification activities and the testing of materials in support of R&D activities and GMP manufacture of Drug Substance and Drug Product. Analytical Techniques HPLC HPLC-MS FTIR KF Conductivity ICP ...
Job Description:
This position provides analytical support for cleaning verification activities and the testing of
materials in support of R&D activities and GMP manufacture of Drug Substance and Drug Product.
Analytical Techniques
HPLC
HPLC-MS
FTIR
KF
Conductivity
ICP
IC
GC
UV
pH
Wet Chemistry (USP)
Analytical Duties
Developing and qualifying (validating) analytical methods capable of detecting low levels
of residues on manufacturing equipment.
Perform swab/rinse sampling on manufacturing equipment in accordance to the qualified
method.
Perform analysis on cleaning verification samples to determine drug and detergent
residues.
Communicate analysis results to his/her supervisor and to the appropriate teams.
Support analysis of raw materials excipients packaging components starting materials
and packaged clinical supplies using various analytical techniques.
Residual Solvents testing by GC.
Routine Water Analysis by KF.
Compile new specifications for raw materials excipients and packaging components.
Assist in the testing of drug substance and drug products as needed.
Requirements
BS/BA in a relevant scientific discipline. Familiarization of analytical instruments making
buffers hands on experience with pH meter chromatography (HPLC and GC) and FTIR.
Detail-oriented and have good problem solving written and oral communication skills.
d
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