Specialist, Qc Bioanalytical - Parsippany, United States - Ferring Pharmaceuticals, Inc.

Ferring Pharmaceuticals, Inc.
Ferring Pharmaceuticals, Inc.
Verified Company
Parsippany, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

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.

As Specialist, QC Bioanalytical you will be responsible for performing laboratory method validation, qualification and transfer activities.

Specialist will perform qualification of compendia methods related to cell-based test assays, routine analysis of cell culture media, reagents, quality of cultured cells in-process, drug substance PCR identification by appropriate analytical or biological methods.

Work independently and assist Seniors when necessary.

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_:
_

  • Performs method qualification and participate in bioanalytical assay transfer to ensure successful startup of QC laboratory. Performs compendia method qualifications.
  • Executes bioanalytical and analytical methods using cell culture techniques, ELISA, cell viability assay, Flow Cytometry and qPCR. Perform routine instrument maintenance and generate data entry and result reports.
  • Monitor instruments for preventative maintenance/calibration and ensure conformance to specifications. Ensure that IQ/OQ/PQ of newly purchased instruments are performed by the vendor in timely manner.
  • Troubleshoot instruments in the lab when necessary. Perform a thorough investigation for any lab event/OOS/OOT/OOE results, under mínimal supervision.
  • Perform routine QC responsibilities such as sample aliquoting, lab equipment maintenance, QC document management, QC inventory control and reconciliation of sample requests/documents, as needed.
  • Generate/Revise general (noncomplex) procedures, protocols, and technical reports as needed.
  • Author test methods and specifications as needed.
  • Initiate and complete QA-Track records when required.
  • Oversee laboratory equipment to maintain optimal temperature and humidity levels, ensuring consistent gas supplies for cell culture facilities.

Requirements:


  • Bachelor's degree in biology, health sciences or other related field from an accredited college or university
  • A minimum of 24 years of relevant GMP experience
  • Working knowledge following Standard Operating Procedure (SOP), cell biology, analytical test methods and generally accepted laboratory practices
  • Skilled with MS Office software
  • Strong attention to detail, i.e., reviewing documentation for adherence to SOP format requirements; accurate data entry of documentation into a database.
  • Comfortable with computerized data storage programs such as LIMS
  • Flexibility to work occasional evenings, weekends, or additional hours, as needed, to support deadlines.

Physical Requirements:

  • Ability to stand, sit, and walk for extended periods.
  • Ability to lift and carry up to 15 pounds.
  • Ability to work in a laboratory environment with exposure to chemicals and biohazardous materials.
  • Ability to wear personal protective equipment (PPE) as required, including lab coats, gloves, safety glasses, and respiratory protection.
Role will be in Parsippany, NJ.

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 wa
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