Scientist - Senior

  • location: Lexington, MA
  • type: Contract
  • salary: $61.01 - $71.78 per hour
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job description

Scientist - Senior

job summary:
As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Our partner recognizes the need for innovative care and utilizes Research & Development to further knowledge in Oncology, Neuroscience, Rare Diseases, and Gastroenterology. As a company that brings in over $30 billion in annual revenue, they have established themselves as a biopharmaceutical powerhouse that is changing the world. If you're looking for a position where your work will benefit millions of people, we are waiting for you!

 
location: Lexington, Massachusetts
job type: Contract
salary: $61.01 - 71.78 per hour
work hours: 9 to 5
education: Bachelors
 
responsibilities:
  • Expertise and technical leadership managing product testing, method validations/transfer, investigations, CAPAs, change requests, and deviations.
  • Manage assay transfer and/or validation activities for QC, including authoring and/or reviewing protocols, coordinating testing with CTLs, performing statistical data analysis and final summary reports per ICH and company internal guidelines.
  • Lead investigator providing technical and analytical representation for QC on investigation teams, with strong understanding of compliance and cGMP's, strong scientific judgment and leadership in decision making.
  • Coordinate analytical support within QC necessary to identify root cause.
  • Facilitate investigations, review of process and method validation initiatives in support of the QC laboratories in the resolution of OOS investigations.
  • Provide technical expertise and support for troubleshooting and assay remediation.
  • Manage and contribute to cross functional teams to close investigations, determination of root cause, and implementation of appropriate CAPAs.
  • Lead management of the document change requests for method SOPs.
  • Works on problems of diverse scope in which analysis of situation or data requires evaluation of identifiable factors.
  • Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Technical Program/project Management (35%)
  • Technical writing-author and review of protocols, reports, data summaries, procedures, LIMS etc. (25%)
  • Support investigations of product deviations (25%)
  • Work with QC, QA, Supply Chain, Analytical Development, Process Development, Manufacturing, Technical Services, Regulatory Affairs, CTLs and CMOs (15%)
 
qualifications:
  • Degree in Chemistry or Biological sciences.
  • 7-10 years' experience in pharmaceutical industries
  • Experience with analytical method validation, product testing and/or GMP investigations
  • Direct experience within GMP organizations, experience in Quality preferred
  • Excellent, professional interpersonal and communication skills (both verbal and written)
  • Demonstrated ability to work effective by independently and on cross functional teams
 
skills: Project Management, Quality control, SOP, CAPA, Laboratory Information Management Systems (LIMS), ICH Regulations, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

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