QC Stability Lead - IMMEDIATE NEED!

WORK WITH THE BEST IN BIOPHARMA! RIGHT HERE! RIGHT NOW!

A Leading BioPharma Company in Irvine is seeking an experienced individual in QC for a newly available position as a QC Stability Lead!

Responsibilities Include, but are not limited to:

Coordinate and execute stability studies, track time points for testing, and ship samples to contract labs.

Work with QC Manager and/or Supervisor to schedule testing within timelines stipulated by protocols.

Write and revise study protocols and reports.

Perform QC sampling and testing to support manufacturing, validation, process development and investigations (as needed).

Continuously work to improve and develop cGMPs and the quality system.


JOB REQUIREMENTS


Perform test methods utilized in stability including but not limited to: HPLC purity/degradation tests, capillary electrophoresis, SDS-PAGE, binding assays.

Design, write and revise stability protocols and reports.

Assist clients and project managers in designing stability programs.

May be designated as study director for stability studies, forced degradation studies, and non-conformance investigations.

Work with business development on cost estimates and timetables

Other functions include: Reviewing data/results, training other analysts, tracking workload and efficiency, estimating billable hours and material costs for new projects, developing and implementing QC procedures and policies. Stability lead will must be aware of company cGMPs and as industry regulations that apply to all stability functions.


EDUCATION/QUALIFICATIONS


BS in Chem/Bio or related field plus 4 years industry experience in a QC or analytical lab, or equivalent combination of education/experience.

Experience with analytical testing and equipment in a cGMP environment, writing reports/procedures/specifications, and regulatory audits are essential.

Applicant should have experience with most if not all of the following: stability studies and applicable regulations for biologic products, protein characterization, formulation and forced degradation studies, electrophoresis, ELISA, liquid chromatography, container closure studies.




job Requirements


Please refer to the job description above.