Location: Gainesville,GA, USA
Why Join Societal CDMO? ?
Mission and Culture:
Each day we Bring Science to Society as we work towards improving the quality of life for patients who benefit from the therapies that we manufacture. We strongly believe that every employee plays an impactful role in accomplishing our mission of improving patients? lives through client partnerships. Whether you are working hands-on in developing, manufacturing, or, testing the products or if you are utilizing your expertise in any other way, through your work here you will have an opportunity to positively affect countless lives.
We foster a culture that is diverse, inclusive, challenging,?and supportive. At Societal, we are committed to continuous improvement both as individuals and as an organization. We encourage our employees to continue their personal and professional development in various ways.
Your New Role At Societal:
We are looking for a highly experienced chemistry to join as Scientist III ? Analytical Development. In this role you will support early-stage product development through commercialization. You will support and troubleshoot the formulation and manufacturing processes, identify potential negative interactions, degradation pathways, subsequent impurities, and degradants. As a Scientist III you will also perform qualification of analytical instrumentation, method development and validation, and method transfer activities.
How You Will Make An Impact:
Utilize knowledge of mechanistic organic chemistry to identify issues in drug product formulations.
Predict impurity profiles and degradation pathways for active pharmaceutical ingredients and drug product by using the structures of active pharmaceutical ingredients and excipients.
Participate in or lead the design/evaluation activities as well as execution of routine and more complex testing or studies.
Provide analytical leadership on one or more client projects and represent the function on client project team(s).
Present interpreted results and updates to internally and to individual clients in a timely and professional manner.
Perform method development/validation and method transfer.
Develops analytical methods for dissolution and chromatographic analysis.
Authors/reviews validation and method transfer protocols.
Acts as subject matter expert for analytical technology transfer.
Review all relevant data (stability, specifications) in order to identify and report trends or OOS results
Participate in or lead problem solving (scientific, equipment, process). Assist in trouble shooting and investigations as required.
Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
Authors/reviews analytical protocols, SOPs, investigations, reports and related documentation.
Assists laboratory management with acquisition, upgrade and qualification of instruments.