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Scientist, QC Microbiology

Employer
Ferring Pharmaceuticals, Inc.
Location
Parsippany Troy Hills, New Jersey, US
Salary
Competitive
Closing date
Jan 31, 2022

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Job Title: Scientist, QC Microbiology Job Description: Contribute to outstanding innovation + Make braver choices Scientist, QC Microbiology Location: Parsippany As a privately-owned, specialty healthcare company, Ferring focuses on developing life-changing innovations that help people 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 commitment to science and research, Ferring is relentless in 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. Summary: The Scientist 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. 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. Responsibilities: * 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 archival and inventory control of consumables, media and garments. Assist with the budget requests, processes purchase orders and capital acquisitions requests (CAR's). * Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed. * Trains junior analysts and develops training plans and/or oversee training activities for groups. Trains Micro Associates on Technical Concepts and Methods. Develops new training materials for microbiological test methods. * May perform other duties as assigned by QC Micro Management. * Work weekends, overtime, on-call and holidays, as needed. Requirements: * Bachelor of Science Degree in Biological or Environmental Sciences from an accredited College or University is required. Master of Science degree preferred. * A minimum of 8 years of QC laboratory (pharmaceutical or biopharmaceutical industry) with a Bachelor's Degree or 4 years of industry experience with a Masters degree. Strong preference for experience in the following: * Cell/Gene Therapy * TT Activities * Cell-Based Assay (ELISA, PCR) * Rapid Microbial Methods * Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices. * Expertise with performing laboratory investigations, change controls, and associated CAPA under limited guidance. * Knowledgeable in Labware LIMS configuration of new analyses and product specification. * Microbiological method development, transfer, and validation experience is highly preferred. * Subject matter expert for all microbiological methods in accordance to cGMP guidelines and compendial requirements and familiar with lean six sigma principles. * Knowledge of USP/EP/cGMP and ICH guidelines; Microbiology techniques and instrumentation; Laboratory Information Management System (LIMS); Global Quality Tracking System (TrackWise); Microsoft Office; Lean Six Sigma concepts; Lean Labs; project management; formal Quality Change Control, Investigations, and Documentation systems, and Quality Risk Management including risk assessments. * Excellent influencing, communication and interpersonal skills, as well as the ability to influence and interact at multiple levels of the organization, manage multiple priorities, and deliver excellent results. * Experience with, or direct knowledge of, several quality system elements (e.g. complaints, document change control, standards and systems management, quality directive and procedures, Annual and Product Quality Review APR/PQR, Compliance related field actions, alerts and like events). * A proven track record of participating in cross-functional teams to achieve significant quality and process improvements is required. * Excellent problem-solver with the ability to work independently. * Partner with colleagues in other departments to increase the overall effectiveness of the Quality Management System. * Excellent written and verbal communication and interpersonal skills; establishes key relationships within business lines. * Strong collaborative and influencing skills. * Meeting management/facilitation skills/teamwork. * Ability to multi-task team is essential. * Flexible and able to adapt to company growth and evolving responsibilities. * Ability to work independently and identify issues, presents complex problems with possible solutions, and actively takes leadership role to resolve of issues. * Applies disciplined principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals. * Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development. * Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail-oriented behavior. * Good judgment and correct decision making based on Ferring procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network. * Proactively identifies, takes remedial action, and/or seeks advice when a personal, project or team goal/deliverable is off schedule. * Delivers on high business impact projects/activities/changes. * Able to holistically review and authorize all laboratory data and has an extensive overall knowledge of all laboratory operations. * Ability to stand on feet for up to four hours at a time. * Be able to lift, push, and /or pull up to 25 pounds. * Meet minimal visual acuity requirements necessary for quality assessments. Prospective new hires for this position must be fully vaccinated against COVID-19 as a condition of employment. Vaccine verification will be required on your start date unless an exemption has been approved by the Company as a medical or religious accommodation. Join our team and you'll become part of a close-knit family - one in which you'll be listened to and your contributions valued. Surrounded by like-minded people, you'll have the support to achieve more. So if you love to come up with new ways to make a positive difference and see them through, welcome to the team. We are proud to be an Affirmative Action/EEO Employer. EOE Minorities/Females/Protected Veterans/Disabled. We maintain a drug-free workplace and perform pre-employment substance abuse testing. Location: Parsippany, New Jersey

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