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Scientist, Qc Microbiology Jobs

Company

Ferring Pharmaceuticals, Inc.
Address , Parsippany
Employment type FULL_TIME
Salary
Expires 2023-12-08
Posted at 9 months ago
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 US is Great Places to Work® Certified. Earning this certification means that Ferring US is one of the best companies to work for in the country. Our people are at the core of what makes Ferring a great place to work. Putting people first, strengthening our workplace culture, and ensuring that it is a safe, equitable, and welcoming place to work is a priority at Ferring, and it always will be.
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry’s most impressive people, these are just some of the ways we live our "People First" philosophy.
  • 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.
  • May perform other duties as assigned by QC Micro Management.
  • Oversee environmental performance qualification of new cleanroom areas. Performs risk assessments and develops sampling plans and site maps for new cleanroom areas.
  • 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.
  • Performs training of new hires and assists junior analysts with water sampling, environmental sampling – routine/batch, gas testing, gown qualification and media fills.
  • Executes stability program including pulling, testing, submitting to external laboratories and protocol and report generation.
  • 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).
  • Leads and performs experimental design, compendia method qualifications and assay transfers to ensure successful project transfer and performance in the laboratory.
  • Authors SOPs, test method, specifications, developmental protocols, method qualification protocols/reports, annual product reviews and technical reports as needed.
  • Perform configuration of new analyses, products and specifications in LIMS as necessary.
  • Work weekends, overtime, on-call and holidays, as needed.
  • Communicates with vendors for laboratory needs.
  • 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.
  • 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.
  • Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending.
  • Issues deviations, laboratory investigations, corrective actions change controls, and monitors effectiveness checks in LIMS and in QA-Track.
  • 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.
  • 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.
  • Supports research laboratories on experimental design and method qualification of clinical or pre-clinical products.
Requirements:
  • Cell/Gene Therapy (CarT)
  • Working knowledge of Standard Operating Procedures (SOPs), analytical test methods, and generally accepted laboratory practices
  • Microbiological method development, transfer, and validation experience is highly preferred.
  • 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.
  • Rapid Microbial Methods
  • Expertise with performing laboratory investigations, change controls, and associated CAPA under limited guidance
  • Cell-Based Assay (ELISA, PCR)
  • Strong preference for experience in the following:
  • Subject matter expert for all microbiological methods in accordance to cGMP guidelines and compendial requirements and familiar with lean six sigma principles
  • TT Activities
  • Knowledgeable in Labware LIMS configuration of new analyses and product specification.
  • 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.
Physical Requirements:
  • 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, and
  • Meet minimal visual acuity requirements necessary for quality assessments.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace and perform pre-employment substance abuse testing.
Ferring offers a competitive total compensation package inclusive of but not limited to the following benefits: medical, dental, vision, 401(k), vacation policy, paid holidays, sick days, paid maternity/paternity leave, tuition reimbursement, flexible savings accounts, short-term disability, long-term disability, life and AD&D insurance.
Location:
Parsippany, New Jersey