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Allergan

Scientist, Biologics Development

Post Date:Oct 19, 2018Type:Full-Time
Start Date:10/12/2018Salary:
Location:US-CA-Irvine Job Reference:US*717_6605
Skills:
 

Job Description:
Allergan plc (NYSE: AGN) is a bold, global pharmaceutical company and a leader in a new industry model - Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceutical, device, biologic, surgical and regenerative medicine products for patients around the world.

Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories. With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives every day.
Allergan is a company that will inspire you to aim high with your ambition. Where you can build bridges all over the world. Where you can power ideas that drive change. And where you will act fast and drive results for customers and patients.  Power your future & join our bold team.
Position Overview
The Scientist is responsible for supporting the development and validation of qPCR, immuno-assay and cell-based assay and safety measurement methods for the characterization of proteins and peptides. He/She independently plans experimental work and executes protocols in support of biopharmaceutical process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual is also responsible for writing (sub)sections of Technical Reports and method or operation SOPs. He/She independently carries out multiple analytical methods to support Allergan biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
 
Main Areas of Responsibilities
  • Executes the development and validation of analytical methods for the characterization of biopharmaceuticals with an emphasis on qPCR, immuno-assay and cell-based assays. Creates written procedures and protocols. Transfers, qualifies or validates methods as needed. Mentors staff within a matrix environment when needed.
  • Applies routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintains reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Complies with Quality Principals related to data generation and reporting.
  • Actively participates on cross-functional teams within Biologics Development and provides support to external departments as time permits. Openly shares scientific expertise and collaboratively helps the team to formulate rational solutions to problems. Shares expertise, instruments and resources within the limitation of established priorities.
  • Qualifies and maintains critical reagents to support development and commercial release testing. 
  • Develops protocols and SOPs, trains staff and maintains the laboratory consistent with departmental and Allergan requirements. Understands, documents and adjusts Quality Systems to match the project stage (e.g. pre-development or development).
  • Maintains a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state of the art production and analytical methods and acquisition of reasonable and necessary equipment.
  • Makes high quality scientific presentations at internal management, regional and national meetings to help advance Allergan’s image as the thought and product leader in the neuromodulator field. Presents and defends product, assay and process data to regulatory agencies.
  • Makes staffing recommendations related to direct reports and communicates desired forward path to mid-and-senior level management for endorsement/implementation. Evaluates performance for direct reports and assists with staff development via recommendations for internal and external technical training and scientific conferences. Consistently treats direct reports and other team members and all Allergan employees with respect
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Requirements
Experience obtained through a combination of appropriate education (Ph.D) and 0-4 years of applied experience. Individuals with a MS degree and 5 or more years of applied experience may also qualify. However, individuals with a BS degree and 7 or more years of experience may also qualify.
Preferred Skills/Qualification
  • Extensive experience with the application of cell culture and bioassay techniques for the characterization of proteins and their degradation and modification products.
  • Skilled in the use of multiple equipment for the characterization of proteins or peptides (MSD Imager, fully automated CSI Imager, Luminex Plate Reader, Synergy Neo2 and Envision Plate reader, SMCxPro, Taqman qPCR, application of liquid handlers in cell-based assay automation and related software for data analysis).
  • Skilled in the use of handling proteins and experience with standard protein analysis techniques such as Western blotting, SDS-PAGE, ELISA, AAV titering with viral genomic DNA staining and qPCR, AAV viral potency assay (TCID50), preparation of cells for neurotoxin CBPA.
  • Ability to create effective experimental designs.
  • Working knowledge of the requirements of working in a GLP or cGMP environments.
  • Excellent documentation and written communication skills.
Education
  • A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
  • Strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.
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Contact Information
Allergan



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