Bachelors in Chemistry with at least 4 years of pharmaceutical or biotech industry experience in analytical methods development, transfer, and testing.
Extensive prior experience in Oligonucleotide analysis, LC/MS and other routine analytical and biophysical techniques such as chromatography and spectroscopy is desired.
Excellent Communication skills required
Having a Masters or equivalent in an appropriate scientific discipline with extensive prior experience in Oligonucleotide analysis is preferred
Indepth knowledge and hands-on experience in oligonucleotide separation and characterization techniques such as LC/MS, HPLC/UPLC and biophysical techniques would be a plus.
Experience with development & optimization of parenteral dosage forms in a GLP/GMP environment is preferred
Experience leading cross-functional projects across matrix lines is also preferred
Experience working with third party and regulatory submission would be added benefits.
Experience working on an independent study or relevant internship
• To progress analytical aspects of projects, utilizing their technical expertise as part of a product development team. Conduct duties as listed below plus any other tasks as requested by team leader or departmental director.
• May perform quality control testing
Key Results (Principal Accountabilities)
• Executes experiments based on established protocols and implements improvements with supervision.
• Identifies and begins to interpret any problems in the execution of experimental processes and/or in results and communicates them to supervisor.
• Operates laboratory equipment independently (but with due regard for GMP and Safety).
• Performs data management tasks including recording results effectively in a lab notebook or computer with minimal supervision (i.e. tabulating and graphing results).
• Begins to proactively seek assistance from other scientists to solve problems.
• Maintains cleanliness in own work area and in communal work areas.
• Anticipates/recognizes potential problems with equipment and/or supplies, and initiates action to solve or prevent problems.
• Works to GMP standards as appropriate
• Follows safe Laboratory Practices.
• Is fully aware of safety requirements for his/her laboratory/working environment
• Attends regular safety training.
• Maintains accurate and complete safety records consistent with company policy and legal requirements.
• Recognizes potential safety problems and takes action to rectify them.
• Perform appropriate Quality Control activities, including-
• Performing analytical testing to support release or rejection of intermediate, bulk and finished products by Quality Assurance
• Developing and proposing stability protocols.
• Developing and proposing specifications, sampling instructions, test methods and other Quality Control procedures.
• Monitoring any contract analytical testing
• Checking the maintenance of premises and equipment.
• Proposing validation protocols and performing appropriate validation of analytical methods.
• Manage and provide technical expertise and external CRO/CMO oversight on the analytical development elements at all stages of product development.
• Be responsible for contributions to analytical sessions for regulatory submissions
You may apply for this position online by selecting the Apply now button.
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