Job Details

Overview

Hybrid, 50% onsite (Tue, Wed, Thurs). First month will need to be onsite every day.

Target Hiring Date

July 14, 2025

Work Authorization

Applicants must have the legal right to work in the United States without requiring sponsorship. Corp-to-Corp (C2C) arrangements are not accepted.

Requirements

Education:

Bachelors Degree required in Engineering or Related Discipline (advanced degree is preferred).

Qualifications:

• Minimum 2 years of manufacturing support or related experience in the biopharmaceutical industry.
• Experience in cell therapy/biologic/vaccine manufacturing support, tech transfer, and validation.
• Design and execute test plans and other risk mitigation exercises as part of investigations (e.g. Root cause analysis and CAPAs).
• Experience in GMP setting and CAR-T cell therapy.
• Sponsor and support the change initiatives and the implementation of process improvement initiatives.
• Support Clinical Production Activities.
• Experience with the start-up, validation, and licensure of new biopharmaceutical manufacturing facilities.
• Basic knowledge of cGMPs and multi-national biopharmaceutical/cell therapy regulations.
• Basic knowledge of facility/clean room design, process, equipment, automation, and validation.
• Intermediate strong verbal/written communication skills and ability to influence at all levels.
• Intermediate ability to think strategically and to translate strategy into actions.
• Intermediate ability to prioritize and provide clear direction to team members in a highly dynamic environment.
• Basic knowledge of quality by design and risk management.
• Basic experience with Operational Excellence and Lean Manufacturing.

About the Role

The Scientist in Manufacturing Sciences & Technology will support the Materials and Cryogenics Science group in the life cycle management of raw materials, consumables and single-use systems utilized 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.

Duties and Responsibilities:

• Qualify alternative raw material suppliers: work with procurement to identify new suppliers; recommend and/or lead necessary testing to qualify material for use in GMP manufacturing; author technical equivalency assessments, specification comparisons and material characterization reports; support risk assessments; author change controls.
• Additional Tasks: support material and consumable manufacturing investigations; evaluate and manage material associated supplier changes notifications to maintain GMP compliance; support material specification development.

Join Sokol GxP Services Where Innovation Meets Integrity!

Join Sokol GxP Services, where we partner with leading pharmaceutical and biotech companies to provide exceptional Commissioning, Qualification, and Validation (CQV) services. We are committed to fostering diversity, empowering local talent, and building strong community connections to bring the best-qualified candidates to our clients in the Summit, NJ area. Our inclusive and collaborative culture promotes growth and innovation.

Lets shape the future of life sciences together!

Our benefits:

• health insurance
• 401(k)
• paid holidays
• UTO

All applicants will receive an acknowledgement that their application has been received within 2-3 weeks from the date of receipt.

Equal Opportunity Employer Statement: Sokol GxP Services is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

By submitting your application and resume, you consent to have your information retained in our repository for six months. This allows us to consider you for future opportunities that may align more closely with your skills and qualifications. If a suitable position becomes available, we will contact you directly.