Scientist I, Quality Control, QC-Stability

Job Description

About This Role

Responsible for contributing to key functional, tactical, and operational aspects of the Product Quality Technical Services QC group at Biogen. Provide technical expertise and leadership for the specification management and stability program management of commercial/clinical products. This includes developing appropriate specification justification and design of stability protocols, maintaining data, expiry dating for products, authoring stability sections for submissions, technical assessment of stability specification changes and stability investigations. Serve as a subject matter expert in multiple disciplines, interfacing with key customers. This requires excellent written and verbal communication skills.

WhatYou’llDo
  • Develop and facilitate specifications for Drug Substance and Drug Product for commercial/clinical programs.
  • Author/co-author Specification Justification documentation.
  • Design and manage stability studies.
  • Independently author stability protocols.
  • Manage moderately complex issues, barriers, problems to support team success.
  • Possess thorough knowledge of methods for data trend analysis and stability data behavior.
  • Perform technical review of complex analytical data, interpret data and author in-depth technically-sound stability reports/regulatory submissions independently.
  • Contribute to major/critical manufacturing and lead stability investigations (deviations, OOS, cross-site and cross-functional).
  • Provide innovative solutions to unique complex problems.
  • Proactively identify technical gaps and areas for improvement related to quality or process and lead them through completion.

Who YouAre

You enjoy stability and/or specification management and are passionate about using data to drive key business decisions. You love learning new skills and working through collaboration.

Qualifications

Required Skills
  • B.S. with 10+ years experience; M.S. with 8+ years experience
  • Advanced knowledge of operations/quality systems/directives
  • Excellent technical writing, presentation and oral/written communication skills
  • Provide leadership for complex situations/issues problem solving to effectively reach solution.
  • Strong organizational skills with ability to multi-task and coordinate multiple activities in parallel.
  • Good knowledge of FDA/EMA regulations and compliance.
  • Leadership competencies include: Follow up, Decision Making, Communication, Collaboration and Innovation.




Additional Information

Biogen’s US Alzheimer’s Franchise is looking to recruit proven and ambitious sales achievers with at least five years of experience in pharma, specialty, hospital, med device/capital equipment, and/or biotech sales.
In this field-based, specialty sales representative position you will be called upon to sell our products with key stakeholders in the Alzheimer’s Disease community: including Neurologists and allied health professionals.

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