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Scientist 3, Stability Science

Apply Now Job ID R-332930 Date posted 03/19/2019

Job Description Summary

This position provides strategy and stewardship for the overall administration of key stability science programs to support BD products currently on the market, new country registrations and/or products under development all while in observance of internal, domestic and international regulatory requirements and pharmaceutical best practices.

The Scientist 3, Stability Science position is key to the execution of the stability testing program to support the approval of new or updated process and/or product design changes and as required, supports the development and validation and transfer of analytical methodologies to support the needs of the business.

Job Description

Education

  • PhD or MS/BS in Chemistry / Pharmaceutics with related science experience.

Responsibilities

  • Oversee the overall administration of select stability programs that are in alignment with the growth strategies of the Infection Prevention organization.
  • Responsible for the development of integral stability study designs and strategies in observance of product requirements, domestic and international market requirements.
  • Responsible for the authoring of stability study protocols and completion summary reports that are inclusive of comprehensive testing strategies to support domestic and international regulatory filings.
  • Responsible for the evaluation and trending of stability data relative to the drug product requirements for shelf life. Responsible for the timely communication of data trending and communication of predictions, anomalies, as relevant to the stability testing program.
  • Accountable for the determination of sample requirements in support of stability testing as well being responsible for the organization and maintenance of stability sample inventory.
  • Ensure the timely retrieval of stability samples at the specified testing intervals and in collaboration with management coordinate testing assignments within the functional area. 
  • Monitor the progress of stability testing programs to ensure the timely testing and initiation as well as stability data evaluated.
  • Develop communication strategies to update management on the status of stability testing.
  • Anticipate challenges and timely communicate challenges with peers and management.
  • Assists in the preparation of stability data per country specific format requirements to support drug product registration.
  • Acts as a subject matter expert for all aspects of administering stability studies and mentors other team associates through the steps of stability testing.
  • Acts as a system administrator of software application for the management of stability science programs. 
  • Responsible for the overall upkeep and operational readiness of environmental chambers and environmental equipment.
  • Coordinate with internal and external parties the scheduling of qualification services for environmental storage equipment and environmental monitoring devices.

Skills

  • Demonstrates developed knowledge of respective scientific discipline and standard scientific method and techniques in the area of expertise.
  • Ability to organize and prioritize work with limited guidance and manage projects in a timely and effective manner to meet project timelines.
  • Demonstrates an advanced understanding of data integrity requirements relevant to the functional area. 
  • Acts as a technical area champion and serves as a resource for colleagues with less experience.
  • Under minimal supervision applies scientific knowledge and skills within respective discipline to product development projects.
  • Develop and implement experimental plans within existing procedures or established standards.
  • Develops documentation and communication strategies to support project deliverables.
  • Proficient with the use of statistical techniques relevant to the evaluation of stability data.
  • Competent technical writing skills pertaining to the development of laboratory systems documentation as well as technical reports based on a given targeted audience.
  • Excellent and proactive communication skills to discuss scientific strategies/results with multi-disciplinary teams (i.e. Regulatory, Manufacturing, and Quality).
  • Assures that all aspects of their assigned areas are secure and maintained in accordance to all applicable procedural requirements.
  • Assists in carrying out business, strategy plans or other duties as assigned by management.
  • Models expected leadership behaviors within the sphere of influence to help drive effective outcomes.
  • Mathematical and reasoning ability. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Ability to work with colleagues and multiple clients in a professional and organized manner, and interact effectively with a variety of people from different nationalities, ethnic/cultural backgrounds, and educational levels.

Experience

  • Education: PHD preferred or MS/BS in Chemistry /Pharmaceutics with related science experience.
  • Experience: 5-10 years of experience in pharmaceutical development and pharmaceutical analysis of topical or other relevant dosage forms.
  • Experience in working within an FDA regulated environment and GMP requirements.
  • Demonstrates an understanding of 21CFR11 requirements for electronic records and electronic signatures as well as the foundational aspects related to data integrity in a laboratory setting.
  • Advanced understanding and experience with ICH guidance related to the requirements for the execution of stability programs (Q1A, Q1B, Q1C, Q1D, Q1E).
  • Previous experience in coordinating and overseeing chemical stability studies for pharmaceutical products.
  • Should be able to define problems, collect and interpret data, establish facts, draw valid scientific conclusions, and propose solutions or corrective actions.
  • Work with management through the identification and delegating of tasks necessary to support project deliverables.
  • Developed acquaintance with pharmaceutical development (Q8) and pharmaceutical risk management (Q9) guidances for industry.
  • Developed acquaintance with relevant ICH and Pharmaceutical Quality/CMC guidance.

Primary Work Location

USA IL - Vernon Hills

Additional Locations

Work Shift

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