Assistant/Associate Scientist, Cryogenics & Materials (GMP)

Spectraforce Technologies; Harvard (MA); On-site; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies is seeking an Assistant/Associate Scientist for 100% onsite work in Devens, MA. The role supports the Materials and Cryogenics Science group in cryogenics, consumables, and single-use systems for biopharmaceutical manufacturing operations.

The successful candidate will collaborate with Manufacturing, QA/QC, Supply Chain, and Global Procurement on cross-functional teams, performing material evaluations, risk assessments, validations, and lifecycle management.

Qualifications

• 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
• Knowledge of manufacturing process validation desired
• Strong organizational, oral communication and technical writing skills; attention to detail; troubleshooting ability
• Effective team player and strong individual contributor

Responsibilities

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

Skills

cGMP awareness

Analytical lab skills

Technical writing

Team collaboration

Education

BS with 2+ years experience or MSc in Chemical/Biochemical/Materials Chemistry

Tools

Analytical instrumentation

Job description

Spectraforce Technologies is seeking an Assistant/Associate Scientist for 100% onsite work in Devens, MA. The role supports the Materials and Cryogenics Science group in cryogenics, consumables, and single-use systems for biopharmaceutical manufacturing operations.

The successful candidate will collaborate with Manufacturing, QA/QC, Supply Chain, and Global Procurement on cross-functional teams, performing material evaluations, risk assessments, validations, and lifecycle management.