Associate Scientist

About This Role

The Associate Scientist supports the Materials and Cryogenics Science group by managing cryogenics, consumables, and single-use systems for biopharmaceutical manufacturing. This role involves technical evaluations, risk assessments, and change management for materials and cryogenics.

Responsibilities

• Support material and cryogenics technical evaluations, risk assessment and change management activities
• Execute material control strategies, validations and qualifications, 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
• Strong organizational, oral communication and technical writing skills
• Strong attention to details, excellent experimental/troubleshooting aptitude, and self-motivated

Qualifications

• BS with 2+ years of industry experience or MSc in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background
• 2+ years of industry experience with a BS or MSc

Nice to Have

• Knowledge of manufacturing process validation

Skills

* Required skills