SOKOL GxP Services is seeking an Assistant / Associate Scientist to support Manufacturing Sciences & Technology activities within a Materials and Cryogenics Science group. This role will focus on cryogenics, cold-chain transportation, single-use systems, materials-related technical evaluations, and lab-based studies supporting commercial biopharmaceutical manufacturing operations.
The successful candidate will work cross-functionally with Manufacturing, Manufacturing Technology, Quality Assurance, Quality Control, Supply Chain, and Global Procurement teams. This position requires strong hands-on laboratory skills, knowledge of protein analytical tools, technical writing ability, and attention to detail in a GMP-regulated environment.
Key Responsibilities:
Support cryogenics and cold-chain transportation lab studies and related technical activities.
Assist with cryogenics, materials, and single-use system investigations supporting biopharmaceutical manufacturing operations.
Execute laboratory experiments and technical evaluations related to materials, cryogenics, and cold-chain performance.
Author and revise CMC documents, protocols, reports, and technical presentations.
Support risk assessments, change management activities, and technical evaluations.
Collaborate with Manufacturing, QA, QC, Supply Chain, Procurement, and technical teams to support commercial manufacturing operations.
Document experimental work accurately and maintain compliance with applicable GMP expectations.
Contribute to troubleshooting, investigation support, and continuous improvement activities.
Requirements
Minimum Bachelor’s degree with 2+ years of industry experience, or Master’s degree in Chemical Engineering, Biochemical Engineering, Chemistry, Biochemistry, Biology, or a related scientific discipline.
Hands-on laboratory experience in a biopharmaceutical, pharmaceutical, biotechnology, or related regulated industry environment.
Knowledge of common protein analytical tools and demonstrated experimental lab skills.
Awareness of cGMP compliance requirements.
Strong technical writing skills, including experience or ability to author protocols, reports, technical documents, or presentations.
Strong organizational skills, attention to detail, and ability to manage multiple technical tasks.
Excellent oral communication skills and ability to collaborate with cross-functional teams.
Strong experimental troubleshooting aptitude and self-motivation.
Ability to work both independently and as an effective team contributor.
Preferred Qualifications:
Experience with MSAT, Manufacturing Sciences, Technical Operations, Process Development, Analytical Development, QC Analytical, or Materials Science.
Exposure to cryogenics, cold-chain transportation, single-use systems, or materials used in biopharmaceutical manufacturing.
Knowledge of manufacturing process validation.
Experience supporting investigations, risk assessments, change controls, or GMP documentation.
Experience in commercial biologics or biopharmaceutical manufacturing support.
Benefits
Competitive hourly rate: $35.9 – $41.9/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
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