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Job description
Overview
The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized for biopharmaceuticals commercial manufacturing operations. The successful candidate will collaborate closely with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement groups on cross-functional teams.
Responsibilities
Qualify alternative raw material suppliers:
Work with procurement to identify new suppliers
Recommend and/or lead necessary testing to qualify material for use in GMP manufacturing
Author technical equivalency assessments, specification comparisons and material characterization reports
Author change controls
Additional tasks include:
Support material and consumable manufacturing investigations
Evaluate and manage material associated supplier changes notifications to maintain GMP compliance
Top Skills / Must Haves
Demonstrated Technical Writing Ability
Worked in Cross matrix Teams
Project Management - fast paced environment and can manage multiple projects at once
Independent Contributor - personable and can work with multiple stakeholders
Change Controls - GMP environments preferred
Qualifications
Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background.
Awareness of cGMP compliance and regulatory agency requirements.
Demonstrated problem solving ability (familiarity with root cause analysis techniques and CAPAs a plus)
Strong organizational, oral communication and technical writing skills
Effective team player and strong individual contributor
Familiarity with analytical techniques (FTIR, SEM-EDS, etc.)
Knowledge of data trending and tracking, including use of statistical analysis software a plus
Physical requirements: No
Additional Job Requirements: Lab w/o blood & animal
Seniorities & Employment
Seniority level Mid-Senior level
Employment type Contract
Job function Research
Industries Pharmaceutical Manufacturing and Biotechnology Research
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Worksite address
ayer, MA, 01432, US
Who can apply
Review the original listing for work authorization, qualifications and employer requirements.