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Sr. Scientist, Biologics Development

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Research & Development
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186565 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 Sr. Scientist is responsible for development, qualification, transfer, and validation of analytical methods for analysis of proteins, peptides, excipients, and impurities to support drug substance process development, drug product formulation development, stability studies, and characterization work.  Provides scientific leadership as an expert in various analytical techniques such as chromatography and capillary electrophoresis and associated detection methods such as UV, fluorescence, RI, light scattering, charged aerosol detector, and mass spectrometry. Responsible for the establishment of analytical development strategies for CMC teams; must ensure the work is performed in a timely manner and consistent with regulatory expectations. Contribute to writing and reviewing protocols and reports for internal use or CMO/CROs as well as for submission to regulatory agencies. Represents Allergan at in-house team meetings and in external scientific and regulatory meetings. Additionally, the Sr. Scientist is responsible for maintenance of analytical instruments such as HPLC, CE and LC-MS.

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

  • Designs and executes/supervises the development, qualification, transfer, and validation of analytical methods using multiple analytical techniques such as HPLC and CE.  Creates written procedures and protocols. Transfers, qualifies or validates methods as needed. Mentors staff within a matrix environment when needed. 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.
  • Applies routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Leads study design, execution, and data summary/report of characterization and investigation studies per project needs.
  • Actively participates on cross-functional teams within Biologics Development and provides support to external departments as time permits. Shall be included on CMC development teams as the SME in Analytical. 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.
  • 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, bioassay 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:

  • Strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development, qualification, transfer, and validation with emphasis on chromatographic and capillary electrophoresis-based methods.
  • Skilled in the application of scientific design principles and analytical techniques to the problems associated with biologicals and/or biopharmaceutical development.
  • Extensive experience with the application of HPLC and CE for the separation, qualification, and characterization of biological molecules including peptide, protein and protein complex in various matrices such as drug products formulated in protein, polymer, surfactant, sustained release drug products.
  • Extensive experience with a wide variety of chromatographic methods for protein characterization (reverse phase, ion exchange, size exclusion, hydrophilic interaction, and affinity chromatography) as well as related techniques such as capillary electrophoresis. Excellent instrument skills including the use of standard and capillary HPLC systems and their associated detectors. Experience with the operation of various instruments such as Waters HPLC, Agilent HPLC, Beckman CE, and Protein Simple systems and familiar with the programs (e.g. Empower) for the instrument control and data analysis.
  • Experience with performing characterization work for regulatory submissions and/or the development of methods for use within a QC environment is required. Must be able to lead cross-functional teams for characterization and investigational studies including designing the study, coordinating the execution, summarizing the results, and reporting in appropriate documentation per project needs.
  • A working knowledge of the requirements of working in a GLP or cGMP environment is helpful.

Education

  • (Ph.D) and 4 to 5 years of relevant industry experience or a MS degree and 7 or more years of applied experience may also qualify.

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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