Category: Scientific & Clinical
Title: Quality Control Supervisor – Immunology
Location: Baltimore, MD
Schedule: 4x 10 hour shifts, Thurs - Sun
Supervision and oversight of analytical or bioanalytical assay development and qualification /validation, performance of testing as required to support product release & stability or nonclinical/ clinical studies (GMP or GLP compliant) or product discovery, proof of concept studies, and candidate selection, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
- Responsible for design, execution and documentation of analytical or bioanalytical assay development, transfer and qualification/ validation studies using spectroscopic, chromatographic, electrophoretic, immunological, in-vitro bioassay or related novel approaches, in collaboration with receiving lab and QA, to meet regulatory and ICH guidelines.
- Responsible for design, execution and documentation of bioanalytical studies for characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
- Responsible for execution, documentation and review of testing as required to support product release & stability or nonclinical/ clinical studies (GMP or GLP compliant) or product discovery, proof of concept studies, and candidate selection, and characterization of products and impurities to support process/product/formulation development, licensure, and product investigations.
- Coordinate daily schedule for lab staff and equipment to ensure that corporate and department objectives are completed efficiently within defined timelines. Reprioritize and adjust as required.
- Ensure that lab activities are conducted according to safety guidelines, policies and legislation.
- Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
- Perform administrative duties such as approval of time documentation. Assist in goal setting and performance review of lab staff.
- Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments.
- Provide information in support of department budget. Contribute to departmental strategy and provide input on lab requirements and improvements.
- University degree in chemistry, biology or related field of study.
- Minimum of five years directly related experience in a recognized professional or technical/scientific field, with a minimum of two years in a leadership role.
- Experience in a pharmaceutical cGMP environment is an asset, but is not required.
- Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
- Proficient and professional communicator, verbally and in writing.
- Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
- Strong organizational and interpersonal skills and the ability to work collaboratively with others.
- Proficient in complex procedures and problem solving.
- Strong commitment to teamwork, proven leadership skills, independence and initiative.
- Proficient in Microsoft Office - Word, Excel, PowerPoint
- Comprehensive knowledge of pharmaceutical GLPs and GMPs
- Comprehensive knowledge of laboratory techniques and safety precautions
- Comprehensive knowledge of WHMIS and biohazard safety
- Comprehensive knowledge of regulatory/industry guidance
- Experience with LIMS and SAP software applications is desired.
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.