Chemist, R&D Analytical

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• Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals.
• Maintain detailed and comprehensive documentation of all work performed.
• Stay current with the scientific literature, particularly in areas that may affect company’s product line, existing processes or potential commercial opportunities.
• Evaluate technology packages from external sources for chemical and cost-effective viability, as directed.
• Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety.
• Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis.
• Provide support to QA/QC by writing analytical SOPs.
• Communicate results by providing timely reports and project updates, to include technical reports and summaries for company business units and customers.
• Provide monthly report on progress of work to the department head.
• Provide help on preparation of quarterly/yearly R&D summaries of ongoing work to peers and senior management.
• Plan and develop robust analytical methods including troubleshooting and validation, as appropriate.
• Work closely with Synthesis group and support on routine analysis.
• Work closely with Quality Assurance (QA) and Quality Control (QC) to identify project needs and to insure strict compliance with internal quality and/or cGMP/ICH guidelines.
• Work closely with QA on validation efforts for new API processes to insure strict cGMP compliance, where appropriate.
• Work closely with R&D team to answer DMF deficiencies and customer queries.
• Maintain rigorous accountability and documentation of work related to controlled substances in accordance with established SOPs and requirements of federal regulations (21 CFR Part ).
• Adhere to all relevant company SOPs and guidelines, and provide input for correcting and changing existing procedures and processes.
• Provide technical support as needed for company products, analytical methods and customer-driven issues, as needed.
• Provide necessary information on cost-saving and time-saving alternatives to current analytical and laboratory practices whenever and wherever possible.
• Assist in supervision of R&D laboratory operations in general, including troubleshooting of lab systems and instrumentation.
• Work with Health, Safety and Environmental representative to identify waste stream data and possible hazards for potential products and processes.
• Assist in the maintenance and cleaning of the R&D laboratory in general and in individual workspace in particular.
• Seek out opportunities for professional development.
• Select and purchase R&D chemicals, glassware and supplies, and track these orders using the established R&D purchase requisition system.
• Execute R&D stability program, to include writing and following stability protocols, and packaging and testing APIs, as well as compiling and reporting stability results to R&D manager.
• Facilitate the training system within the R&D department in coordination with the requirements set forth by QA.
• Other duties as assigned.

• Maintain the highest standards of scientific professionalism. When in doubt, get feedback from other R&D/Technical professionals.
• Maintain detailed and comprehensive documentation of all work performed.
• Stay current with the scientific literature, particularly in areas that may affect company’s product line, existing processes or potential commercial opportunities.
• Evaluate technology packages from external sources for chemical and cost-effective viability, as directed.
• Perform literature searches for development work, potential projects, and to support QA/QC and Environmental/Health & Safety.
• Provide ideas for investigation with an emphasis on commercialization, patent opportunity, or publication on a regular basis.
• Provide support to QA/QC by writing analytical SOPs.
• Communicate results by providing…