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Sr. Scientist, Biologics Development

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Research & Development
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185296 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, Purification will be an instrumental team member of the Biologics Development Process Sciences Department, based in Irvine, CA.  The primary roles of this position are to independently plan, design, and execute the experiments and develop processes to support the purification of natural and recombinant proteins (including neurotoxin and antibodies) from bacterial as well as mammalian cell cultures at small and intermediate scale during various stages of development. This hands-on position is responsible for the development of experimental methods, techniques and processes by applying quality by design (QbD), scientific and/or engineering principles and statistical process design/analysis to develop robust purification processes. The candidate must have in-depth knowledge and experience including but not limited to: chromatography processes, ultrafiltration/diafiltration, process characterization and optimization, process scale up, scale down model qualifications and validation. This incumbent also conducts research in the area of purification sciences in support of innovative process/product development both for new biological entity and life-cycle management of the product. The successful candidate is required to have proven experience of technology transfer to the global manufacturing network (internal or external) including documentation and know-how.  The position will represent department and participate in CMC/project team meetings, prepare research reports and present findings in the multidisciplinary team environment. This position also requires a desire and ability to work as an integral part of a team and supporting drug discovery teams as well as demonstrate a high degree of flexibility, creativity, and initiative applied to the various duties and aspects of position. The Sr. scientist will exhibit leadership skills that results in good performance and career development of junior staff and possess excellent communication (oral and written) and interpersonal skills.

Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements.  Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives. 

Areas of Responsibilities

  • Design and execute lab-scale and scale-up process development and characterization studies, writing technical documents, participating in meeting discussions, and supporting and leading other tasks related to developing a robust process design.
  • Strong development experiences in bringing pipeline molecules from Phase I to commercial, particularly in the areas of process characterizations, tech transfers and validations to internal and external manufacturing sites.
  • Provides timely on floor support and troubleshooting experiences in clinical manufacturing facilities.
  • Well-versed in Phase I to III IND filings, analytical tests, drug substance quality assessments.
  • Communicates and presents scientific and technical information within area of expertise to a cross site/cross functional audience.
  • Operates effectively cross site and remote communication in a team matrixed environment
    Possesses technical leadership supporting risk assessments (including Design Qualification, Job Hazard Assessments, Process and Quality Risk Assessments)
    Excellent writing skills for data analysis, technical protocols, technical reports and technical assessments.
  • Leads or serves as a subject matter expert in specific Drug Substance, Biologic Development Pharmaceutical Science Group.
  • Independently operate and have sound knowledge of AKTA pure and AKTA Ready chromatography systems. Position requires proficient knowledge and hands on experience of clarification equipment as well. 
  • Author and edit development batch records and associated standard operating procedures. Compile experimental batch records and documents/inventory for in-process samples in the inventory system.
  • Collaborates effectively to achieve results as an individual as well as part of a team environment.
  • The Sr. Scientist must complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain all training to current status. Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
    #LI-PD1

Requirements

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

  • Hands-on experience in the operation of purification AKTA chromatography system is required.
  • Must have extended knowledge of chemical principles applicable to protein purification
  • Must work in a team setting with other members of the group and prioritize and allocate time and effort appropriately
  • Must demonstrate success in technical proficiency, scientific creativity, collaboration with others and independent thought
  • Must be self-motivated to develop and evaluate hypotheses as they pertain to protein purification and the resulting scale up of purification processes

Education

  • PhD in Biological Science, Biochemistry, Protein Chemistry, Biochemical/Chemical Engineering or a related Life Science field with 3+ years of relevant industrial experience or MS with 5+ years or BS with 8+ years of related work experience.

#LI-PD1

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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