Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability, and various protocol studies using test methods derived from the various compendia and non-compendial sources. This position is expected maintain operational and GMP readiness of the QC laboratory areas. In addition, the individual will participate in more complex projects, operational excellence initiatives, method/equipment validation, method transfer and various quality systems with little to no supervision, and may be asked to take lead roles for the QC organization on these initiatives. Position is expected to act as a role model for junior staff in the various QC areas.
Product Testing: Area focuses on techniques such as HPLC, SDS-PAGE, Capillary Electrophoresis, and Potency.
- Perform and troubleshoot HPLC based assays (SEC-HPLC, SAX-HPLC, RP-HPLC, Peptide Mapping, and Glycan Mapping) of release and stability samples of all Shire products
- Review QC analytical assays
- Execute and lead method qualification and validation assays as needed
- Perform and lead OOT, OOS, GMP Investigations, data analysis, deviation and data trending
- Maintain GMP condition of the lab
Testing execution 30-50%:
QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary) 20-30%:
Compliance and quality systems (SOP revisions, input to quality systems records) 10-30%:
Participate in training analysts; troubleshooting of test methods Education and Experience Requirements:
Typically requires a bachelor's degree and a minimum of 5 year of related experience. (Science related degree is preferred) Additional Specific Experience: Previous experience in a GMP QC role is preferred. Other Requirements:
Some travel expected; although not routine. The following physical abilities are required in order to fulfill the job duties: -Repetitive bending and reaching to setup and break-down equipment -Ability to work around chemicals -Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases -Ability to walk and stand for periods of time -Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours