Roles and Responsibilities:
- The R&D Chemist (RDC) reports to Quality Control (QC) Management.
- The R&D Chemist (RDC) work closely with Product Development and Quality Control.
- The RDC will be the Liaison between Quality control, Product Development, and Contract laboratories by evaluating and Assessing testing methodologies and their application to different sample matrix. This responsibility also includes the evaluation of testing results from contract laboratories to be sure that the agreed methods and testing parameters were properly followed.
- The RDC will help with testing routine and non-routine samples as needed in the Quality Control laboratory. In cases were new samples are received from potential suppliers, the RDC will evaluate testing feasibility in-house before sending to contract laboratory.
- The RDC will work with stability program personnel by keeping up with how new products are behaving during stability studies. This knowledge will be necessary for the RDC to create R&D specifications for raw materials and finished products.
- The RDC will stay current on publications released by USP, FDA and other pertinent regulating bodies to ensure the Quality Control Chemistry Laboratory complies in the areas of analytical applications, release specifications, and documentation practices.
- The RDC will assist in evaluating new testing applications and instrumentation, either developing methods or adopting compendial methods. This person will aid in transferring these new methods into a Quality Control function for routine use. The RDC will ensure at the least, these methods are accurate, precise, and robust for daily use on specific samples.
- The RDC will assist the laboratory personnel in resolving Out of Specification (OOS) results in the analytical laboratory. S (he) will ensure the proper use of the analytical instrumentation and there are no malfunctions causing the OOS result. The RDC will ensure there are no other interferences coming from the product formulations causing the OOS result.
- The RDC will assist in training new laboratory personnel. All training performed under the supervision of the RDC will be documented in accordance with established SOPs.
- The RDC will follow Current Good Manufacturing Practice (cGMP) documentation guidelines to record all procedures in a timely fashion. The RDC will maintain a safe working environment and will ensure that all equipment used in the testing procedures is calibrated and properly maintained.
- Advanced understanding of experimental design, chemical theory and analytical instrumentation like HPLC, GC, ICP-MS, ICP-OES etc
- The RDC should be able to handle specific projects and other necessary functions required in meeting company objectives.
- ?Communicate effectively with other departments within the organization and function within a team environment.
The RDC will have five or more years of laboratory experience in a cGMP facility, including experience with the proper operation of laboratory instrumentation, troubleshooting, and the generation and revision of SOPs and test methods. Effective interpersonal, self-motivation skills, and the ability to interact with all levels of personnel are required. Some Method development and validation experience is a requirement for this position. Familiarity with product development cycle is a plus.
Education and Experience:
A Bachelor of Sciences (B.S.) or Bachelor of Arts (B.A.) degree in Chemistry or a related science is required for the RDC position.