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CURRENT OPPORTUNITIES |
Job Title: Scientists (SAS005)
Job Requirements:
Must have a Master’s Degree or its equivalent (Bachelors degree plus 5 years progressive experience after college) in Chemistry or Pharmacy plus skills and working knowledge in HPLC/UPLC, dosage form design, preformulation, cGMP, ANDA, and Electron Microscopy.
Job Description:
Formulate and produce drugs dosage forms using dosage form design; Conduct preformulation studies using HPLC/UPLC, HPTLC, DSC and Electron Microscopy; Design and analyze dosage forms including Sustained Release Tablets, Capsules, Orally Disintegrating Tablets, Immediate Release Tablets, Topical Gels, and Oral Suspensions; Conduct drug-excipients compatability studies including solubility, and solution stability in different pH conditions; Analyze dosage form samples for Assays, Impurities, Dissolution, Particle Size, Residual Solvents using HPLC/UPLC, UV, GC, Particle size analyzer and DSC; Summarize data for regulatory affairs and ANDA submissions; Conduct and prepare method validation reports in accordance with SOPs; Review and evaluate raw materials to develop product specifications following cGMP and FDA guidelines.
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Job Title: Sr. Process Engineer (RAE001)
Job Requirements:
o Must have a Master’s degree in Chemical Engineering, Industrial Pharmacy or Mechanical Engineering plus skills and knowledge in ANDA/NDA, Pre-validation, Process design/validation/optimization, Scale-Up, Solid/Liquid Dose Manufacturing Process, statistical analysis and techniques.
Job Description:
Lead process design, validation and operations applying knowledge of Manufacturing Process, statistical analysis and techniques; Design plant equipment and devise processes for Solid Dose/Liquid Dose Manufacturing Process specific to ANDA submissions; Optimize the manufacturing process for pharmaceutical drug product reproducibility; Design and prepare pre-validation batches and protocols with sampling plans; Establish the process parameters for the scale-up of approved exhibit batches from lab scale to commercial scale; Evaluate equipment and process, implement safety operating procedures and ensure production and environment safety in compliance with regulations; Perform process control, adjust variable production conditions and determine the most efficient process; Prepare and document master manufacturing batch records detailing manufacturing process, process controls, in-process testing, yield specifications, reconciliations and CGMP instructions.
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JOB OPPORTUNITIES
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| When applying for an open position at Novel, please either mail or email your resume referencing the job code to the following: |
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Human Resources,
Novel Laboratories, Inc.,
400 Campus Drive,
Somerset, NJ 08873,
hr@novellabs.net
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| Only those considered for employment will be contacted. |
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