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Sr. Scientist, Biologics Development

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Research & Development
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186563 Requisition #
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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 Senior Scientist is responsible for leading the development, qualification, transfer and validation of qPCR, immuno-assay, cell-based assay. He/she would be responsible for critical reagents production and qualification 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. The candidate should have a clear understanding of QbD principles, ICH guidelines, and statistically-based DOEs. The candidate will lead or provide technical input and expertise to cross-functional project teams, prepare cogent written and oral presentations, and actively support CMC activities of biologics programs within Allergan.

 

Position requires individual to work with Select Agents. Access to, and use of, select agents is covered by Federal policies. Violation of, or failing to support the intent of, Select Agent policies, regulations, or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.

 

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.
  • Establishes strategies and associated project timeline for the analytical development aspects of CMC plan for Allergan Biologics Development. Contribute to the writing of the CMC sections of regulatory submissions.
  • 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.
  • Production and qualification of 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. 

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Requirements

The following listed requirements need to be met at a minimum level to be considered for the job:

  • 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, qualification, transfer and validation with emphasis on immunoassay and bioassay.
  • Skilled in the application of scientific design principles and analytical methodologies to the problems associated with biologicals and/or biopharmaceutical development.
  • Extensive experience with the application of cell culture, molecular biology, 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, Surplace Plasmon Resonance, and 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, residual DNA analysis by qPCR, and TCID50 qPCR endpoint assay for AAV, preparation of cells for neurotoxin CBPA.
  • Working knowledge of antibody purification, conjugation, qualification
  • 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

  • Ph.D and 4-5 years of applied experience OR MS degree and 7 or more years of applied experience OR BS degree and 11 or more years of experience.

Equal Employment Opportunity Employer


Allergan is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other protected status.

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