Description
Kelly Scientific Resources is currently seeking a Quality Control Manager-Stability Program for its Seattle QC department. This is an exciting position accountable for providing leadership and management of the corporate stability programs in accordance with appropriate regulatory, corporate and scientific guidelines. In addition, the successful candidate will oversee QC activities at contract manufacturing organizations. This person also leads, develops and mentors reporting staff at a variety of levels. The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.
Responsibilities: ' Responsible for the design and execution of stability studies for multiple products (cell immunotherapy, biologicals, proteins, devices, small molecule, etc) across multiple organizations. ' Responsible for writing of stability documentation (protocols, reports). ' Responsible for stability data trending, product shelf life projection, and stability specification justifications. ' Responsible for reporting of stability data for annual IND and BLA updates. ' Oversees QC activities at contract manufacturing organization, including the coordination of release and stability testing, data review, and issuance of CoA. ' Liaises with Contract Manufacturing on daily operations. ' Collaborates with other departments as part of inter-functional project teams. ' Participates in planning and process/policies improvement activities at the departmental and inter-functional level. ' Sets goals, and conducts performance reviews of direct reports; performs ongoing assessment of development and training needs of reporting staff to ensure continued development of personnel. ' Participates in development and is accountable for adherence to departmental budget.
Requirements: ' Bachelor's degree in Biology, Biochemistry, Chemistry or other relevant scientific discipline, or equivalent. ' Typically a minimum of 7 years related experience in a cGMP Quality Control department in a FDA regulated industry (drugs/biologics) with at least 3 years in a leadership role. ' Thorough knowledge of ICH, and FDA stability guidelines. ' Experience in design and implementation of stability studies for biological and devices products. ' Experience with cell based assays and statistical analysis of biological products attributes preferred. ' Experience with inspections/audits by the FDA and other regulatory agencies. ' Proficient in MS Office applications ' Limited travel required. ' Limited handling of laboratory equipment, chemicals and biological materials.
This is a direct hire position in beautiful downtown Seattle. Interested candidates should apply on-line to kellyscientific.com or
[Click Here to Email Your Resumé] Kelly Scientific Resources is a global scientific staffing organization dedicated to helping scientists of all levels, from entry level to PhDs, advance their careers in industry. We have multiple opportunities available with industry leaders in environmental science and consulting, biotech/pharmaceutical, food science, and manufacturing. Click "Apply Now" to be considered for all positions meeting your qualifications! Learn more at
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