Planet Pharma
Research Associate/SRA Job Description for the Cleaning, Compendial, and Materials Group
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.
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 level 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.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Science and Research
Industries
Pharmaceutical Manufacturing
Biotechnology Research
Medical Equipment Manufacturing
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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.
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 level 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.
Seniority Level
Entry level
Employment Type
Contract
Job Function
Science and Research
Industries
Pharmaceutical Manufacturing
Biotechnology Research
Medical Equipment Manufacturing
#J-18808-Ljbffr