What are the responsibilities and job description for the Scientist II ? Analytical Development position at Societal CDMO?
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 Scientist II in the Analytical Development Department. In this role, your primary objective is to support early-stage product development through commercialization. You will perform such as analytical testing, method development and validation, method transfer, and equipment purchase and qualifications.
How You Will Make An Impact:
Perform testing and data peer review in accordance with written procedures for stability, clinical, formulation development, and method development/validation.
Documents laboratory activities
Process electronic data using procedures that ensure data integrity
Perform and document daily standardization and performance verifications on laboratory equipment
Perform controlled substance chain of custody documentation and reconciliation
Evaluate and interpret the test and experimental data, and draws a conclusion based on results.
Resolves technical issues and interprets and uses experimental data to expand on issues.
Troubleshoots technical procedures, methodology and instrumentation
Transcribes results into analysis reports
Performs method development/validation and method transfer
Develops analytical methods for dissolution and chromatographic analysis
Acts as a subject matter expert for analytical technology transfer
Authors/reviews analytical protocols, SOPs, reports and related documentation.
Ensures laboratory reference standards are maintained in compliance with controlled substance and site SOPs and the site EH&S manual.
Assists with periodic maintenance/calibration of laboratory equipment.
Assists laboratory management with acquisition, upgrade, and qualification of instruments.
Complies with site wide and departmental procedures including but not limited to change control, documentation, deviation reporting, cGMP compliance, safety and electronic data security.