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