Associate Scientist

Job Description

Job Summary:

• The Associate Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the run the business work for cryogenics, consumables and single-use systems 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:

• Support material and cryogenics technical evaluations, risk assessment and change management activities.
• Executes material control strategies, validations and qualifications, as appropriate, including life-cycle management.
• Evaluate and manage material associated supplier changes notifications to maintain GMP compliance.
• Support cryogenics and cold-chain transportation related lab studies or activities.
• Assist material and cryogenics manufacturing investigations.
• Author and revise CMC documents as appropriate.
• Author protocols, reports, and technical presentations.

Requirements:

• Minimum BS with 2+ years of industry experience or MSc in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background.
• Awareness of cGMP compliance and regulatory agency requirements.
• Knowledge of common protein analytical tools and demonstrated experimental skills for lab work are required.
• Knowledge of manufacturing process validation desired.
• Strong organizational, oral communication and technical writing skills.
• Strong attention to details, excellent experimental/troubleshooting aptitude, and be self-motivated.
• Effective team player and strong individual contributor.

Additional Job Requirements:

• Lab w/o blood & animal.
• Position Handles Hazardous Materials.