Scientist

Job Description

Job 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.

Duties and Responsibilities:

1. 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.

2. Additional Tasks would include:

• Support material and consumable manufacturing investigations.
• Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
• Support material specification development.

Education and Experience:

• Minimum BS/MS with 2+ years of industry experience post-graduation or PhD in Material Science Engineering, Chemistry or equivalent scientific background.
• Investigation Experience.
• Bio Pharma experience preferred.

Knowledge, Skills and Abilities:

• 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.
• 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

Physical Requirements:

• Lab w/o blood & animal.