To provide technical development and support for Manufacturing, Chemical Research and Development, QC and Purchasing. To provide development and support for theintroduction of new products and to support, optimize and refine methods of operation and processes for existing products used in cGMP manufacturing of pharmaceuticals and pharmaceutical intermediates.
Essential functional duties of the position
Execute contract projects independently. Document and reportresults of development and experimentation to Department Head.
Development and evaluation of new chemical process technology and methods. Introduce, optimize, validate and support new processes into the laboratory, kilo lab, plant, or pilot plant facility.
Develop strategies to optimize production processes withrespect to yield, quality, throughput, cost and minimization ofwaste streams. Implement programs as required to optimize processes and resolve issues.
Prepare laboratory, kilo-scale and pilot-scale quantities ofmaterials.
Provide detailed instruction and/or training to site employees.
Prepare and evaluate process descriptions, procedures, process flow diagrams, process summaries, throughput, mass balance and chemical process information, raw materials and process economics.
Write detailed reports on work and activities including periodic reviews of work and special work summaries such as validation reports, process summaries, etc., as required
Search and review scientific literature as required to plan and conduct sound and reasonable experimental strategies in a concise and expeditious manner.
Ability to supervise a project team and directly communicate with customers in consultation with AMRI/Euticals marketing team, and suppliers, to address technical issues.
Regularly communicate and present results of work performed in a clear, concise and accurate manner.
Prepare and review written instructions (batch sheets, SOP’s etc.) to ensure that the products are made safely and under current good manufacturing practices.
Maintain complete and up to date files for existing projects.
Review proposed changes from a safety, practicality, feasibility, and GMP perspective following “Management of Change” protocol.
Perform laboratory experiments that are scientifically sound and generate valid data for making technologically sound decisions. Laboratory technique must be reproducible with no inherent bias.
Conduct all job responsibilities in a manner consistent with all applicable safety and environmental laws and regulations, company policies and procedures, site chemical hygiene plan, regulations, and commit to continuously improve safety and environmental performance.
Keep the R&D Director up to date and informed of any significant results, events, deviations from expected results, or work being conducted or envisioned that may impact thebusiness.
Perform statistical evaluations of laboratory and plant data to determine relevance and applicability of data.
Work with Analytical group to assist in development ofanalytical methodology or standards for new or revised processes.
The following knowledge and proficiency skills are required for this position to be acquired through:
PhD Organic chemistry with 5 years or more relevant experience. Experience working with FDA, EPA, and OSHA regulated pharmaceuticals manufacturing requirements. A broad knowledge of modern synthetic organic methodologies and experience in multi-step synthesis of laboratory, kilo-scale, pilot-scale and process scale-up to commercial quantities of materials.
Effective communication skills for preparation of written technical reports, presentations, SOP’s, batch sheet instructions and effective participation in meetings, problem solving exercises, etc.
This position also requires the ability to use computer software such as word processors, spread sheets, databases, etc.
Ability to use and interpret data from modern analytical equipment such as NMR, HPLC, IR, etc.