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Biogen

Develops therapies for neurological disorders

Senior Associate 1 - Quality Control Raw Materials

Regulatory & Quality (Life Sciences)Posted on Nov 13
Full-timeResearch Triangle Park, Durham, NC, USAIn-person

About the Job

Requirements

  • A Bachelor's degree, preferably in a science-related field, plus at least 2 years of GMP pharmaceutical or biotechnology QC industry experience; alternatively, an Associate's degree plus at least 4 years of experience, or a Master's degree plus at least 1 year of experience.
  • Experience with raw material and compendial testing.
  • Experience with gas chromatography analytical testing.
  • Experience with method validation and qualification.
  • Technical report-writing ability.
  • Experience reviewing data integrity and documentation.
  • Scientific troubleshooting and problem-solving ability.

Responsibilities

  • Perform raw material sampling and testing.
  • Execute compendial and non-compendial analytical testing methods, particularly gas chromatography and liquid chromatography–mass spectrometry.
  • Conduct method validations, qualifications, and laboratory studies.
  • Author investigation reports, protocols, change controls, and technical documents.
  • Support investigations, corrective and preventive actions, and quality system activities.
  • Review analytical data and documentation for accuracy and compliance.
  • Troubleshoot laboratory methods, instrumentation, and testing issues.
  • Partner with Manufacturing, Quality, and cross-functional stakeholders.
  • Support process validation and continuous improvement initiatives.
  • Mentor junior team members and provide technical guidance.

Desired Qualifications

  • Experience with liquid chromatography–mass spectrometry analytical techniques.
  • Experience with high-performance liquid chromatography testing.
  • Leadership or mentoring experience.

About the Company

Biogen

Develops therapies for neurological disorders

Biogen is a global biotechnology company focused on neuroscience. It discovers, develops, and delivers therapies for neurological disorders, such as multiple sclerosis and other neurodegenerative diseases. Its product process starts with research and development to identify potential drugs, followed by clinical testing and regulatory approval, ultimately leading to commercialization and patient treatment. Biogen differentiates itself through a long history (founded in 1978), a deep specialization in neuroscience, and an integrated pipeline that moves ideas from discovery to approved medicines, aiming to create value for shareholders while helping communities. The company’s goal is to advance therapies for neurological diseases to improve patients’ lives and generate sustainable value for stakeholders.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Cambridge, MA
Founded
1978

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