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
Employee referral bonus program