Associate Scientist - MSAT (Biologics Manufacturing, Materials, Polymers) presso SOKOL GxP Services
SOKOL GxP Services · Devens, Stati Uniti d'America · On-site
- Ufficio in Devens
Description
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.
The subject matter expert for this position will be primarily required to:
- 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.
Position Handles Hazardous Materials
Requirements
Requirements:
- Minimum B.S. with 2+ years of industry experience; or M.S. in Chemical Engineering, Biochemical Engineering, Material Science Engineering, Chemistry or equivalent scientific background.
- Required knowledge of common protein analytical tools and demonstrated experimental skills for lab work.
- Awareness of cGMP compliance and regulatory agency requirements.
- Knowledge of Material science and polymers.
- Knowledge of manufacturing process validation is a plus.
- 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.
Benefits
Competitive hourly rate: $38 – $45.5/hr (W-2 only, no C2C)
Working Hours: Monday - Friday, regular business hours
12-month contract with possible extension
Health insurance, holiday pay, 401(k) program, and other benefits
Employee referral bonus program
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