Our client, a leading pharmaceutical company, is hiring a Scientist, on a contract basis.
Job ID: 83287
Work Location:
Devens, MA – 50% on site
Summary:
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.
Education/Experience:
- 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
Knowledge/Skills:
- 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
- Investigation Experience
- Bio Pharma experience preferred
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
- Support risk assessments
- Author change controls
- Support material and consumable manufacturing investigations
- Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
- Support material specification development
Pay: $73-$75/hr