Scientist, QC Bioanalytical

Job Description:

As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our ‘people first’ philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world’s oldest enemy: disease.

Ferring is on a mission to transform the treatment of bladder cancer with a novel, first-in-class intravesical gene therapy that provides patients with an alternative to bladder removal surgery. Our Uro-Oncology team is growing with a variety of rewarding opportunities in commercial, medical affairs and technical operations. If you are energized by the prospect of bringing the benefits of cutting-edge science to meet the needs of patients, we may have the perfect role for you.

The Scientist, QC Microbiology position leads and/or is actively participates in experimental design, method validation/qualification, equipment qualification and technical transfer activities of compendial methods related to raw materials and finished product. Performs routine (and non-routine) quality control testing of raw materials, in-process materials, drug substance, finished goods and stability samples.

This is your opportunity to play an important role in making available to patients a novel product that has the potential to revolutionize the treatment of bladder cancer!

With Ferring, you will be joining a recognized leader, identified as one of “The World’s Most Innovative Companies” by Fast Company, and honored by Fortune with inclusion on its “Change the World List,” for addressing society’s unmet needs. Ferring US is also Great Places to Work® Certified, distinguishing it as one of the best companies to work for in the country.

Responsibilities:

• Responsible for authoring development protocols, final summary reports, investigations, change controls, risk assessments, trend reports and training. Is the subject matter expert for all microbiological methods in accordance to cGMP guidelines.
• Highly knowledgeable with compendial requirements and familiar with lean six sigma principles. The Scientist will collaborate with the Manager, QC and Team Leaders in support of leading and providing direction to laboratory staff for maintaining effective and efficient department operations.
• Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory. 
• Executes microbiological methods using, but not limited to, Bioburden testing, Microbial Limits Testing, Antimicrobial Effectiveness Testing, Sterility Testing, and Bacterial Endotoxin Testing, and Microbial and Fungal Identification.
• Executes stability program including pulling, testing, submitting to external laboratories and protocol and report generation.
• Performs training of new hires and assists junior analysts with water sampling, environmental sampling – routine/batch, gas testing, gown qualification and media fills.
• Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.
• Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.
• Perform configuration of new analyses, products and specifications in LIMS as necessary.
• Communicates with vendors for laboratory needs.
• Creates, reviews, and performs authorization of GMP data on paper, logbooks and in LIMS, including but not limited to test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc. Ensures adherence to regulatory agency requirements, ICH guidelines, Ferring standards and procedures.
• Monitors the life cycle microbiology instruments for preventative maintenance and calibration - ensuring conformance to specifications.  Ensures lab equipment conforms to specifications. Oversees the execution of IQ/OQ/PQ of new purchased instruments in a timely manner. Troubleshoots instruments in the lab when necessary. 
• Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track.
• Oversees QC document management and