Job Description

Assistant/Associate Scientist
Job Number: 21-08559
Be part of a company that delivers life-changing healthcare solutions. Eclaro is looking for an Assistant/Associate Scientist for our client in Devens, MA
Eclaro’s client is a leader in the Biopharmaceutical Industry, providing quality, innovative, and affordable medicines that make a difference in the lives of patients all over the world. If you’re up to the challenge, then take a chance at this rewarding opportunity!
Position Overview:
  • The primary role is to support the technology validation and transfer process for late stage and marketed biologic products while ensuring compliance with cGMP requirements and global regulations as part of the team
  • Will prepare documentation, perform data review and verification and contribute to continuous improvement initiatives
  • Prepare/review documentation (e.g. protocols, reports, master plans, and technical reports) to support method validation and/or transfer
  • Performs data review and verification
  • Maintain project tracking and status update communication tools for MTV team
  • Maintain the infrastructure of templates and other supporting documentation to ensure efficient and effective operations
  • Support implementation of analytical method change control as needed throughout the Client network
  • Assist with health authority responses, as requested
  • Assist with regulatory filings, including ROW submissions, as requested
  • BS degree in Biochemistry, Chemistry, Biology or related field, along with 2 or more years relevant work experience or MS in Biochemistry, Chemistry, Biology or related field
  • Understanding of ICH and pharmacopeia for validations
  • Must perform work in accordance with GMP requirements
  • Must have the ability to critically evaluate and analyze technical information presented in documents for adherence to written procedures
  • Must be detail oriented, able to multi-task, conscientious, motivated, flexible and have ability to handle multiple projects
  • Demonstrated knowledge of the biological drug development process and basic concepts of Good Manufacturing Practices (cGMP)
  • Working knowledge of Microsoft Office applications (Excel, PowerPoint and Word)
  • Ability to give clear and concise oral and written communications
  • Ability to work collaboratively to meet shared objectives in a dynamic and matrix team environment
If hired, you will enjoy the following Eclaro Benefits:
  • 401k Retirement Savings Plan administered by Merrill Lynch
  • Commuter Check Pretax Commuter Benefits
  • Eligibility to purchase Medical, Dental & Vision Insurance through Eclaro
If interested, you may contact:
Jane Bautista
Jane Bautista | LinkedIn
Equal Opportunity Employer: Eclaro values diversity and does not discriminate based on Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

Application Instructions

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