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Title: Sr. Quality Control R&D Scientist
Location: Exton, Pa
Schedule: M-F 8am-4:30pm
Type: 6 month contract to hire based on performance
Start date: Immediate
Our client is a late-stage cell and gene therapy company seeking a senior-level candidate who is looking for career growth into a management position. The quality control group is heavily involved with the R&D group as they work together to create transformative therapies that improve the lives of people living with genetic diseases. The ideal candidate will possess a robust technical proficiency encompassing PCR, flow cytometry, cell culturing, and ELISA methodologies
Responsibilities:
Execute Analytical Test Methods for bulk intermediate testing and final product release testing.
Execute testing for raw materials.
Author and revise QC SOPs and ATMs as necessary to maintain compliance.
Review of Quality Control raw data for accuracy, completeness, and compliance with effective SOPs to ensure the strength, identity, safety, purity, and quality of the product.
Timely response to Out of Specification (OOS) results, including notification to area supervision.
Communicate with the individual Operations Departments (Manufacturing, Quality Assurance, Facilities) to ensure that Company objectives are met on schedule.
Maintain housekeeping in the laboratories.
Assist the Quality Control Supervisor in daily operations, as needed.
Authoring and/or executing protocols and generating technical reports.
Analytical test method qualification and validation.
Equipment qualification and preventative maintenance.
Training of other employees.
Completion of thorough Laboratory Investigation Reports (LIRs) to ensure that potential problems and root causes are identified, impact is assessed, and actions to prevent recurrence are considered and implemented.
Requirements:
Minimum Bachelor of Science degree in a scientific discipline
7-10 years’ experience in Quality Control within biologics
Strong skills in flow cytometry, ELISA, and PCR
Knowledge of laboratory skills are required
Knowledge of Current Good Manufacturing Practice and Industry standards
Familiarity with analytical equipment including UV absorbance plate readers, Flow cytometers, microscopes, automated cell counters, and PCR thermal cyclers.
Experience in aseptic processing and mammalian cell culture production
Must be open to occasional off shift and weekend work.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.