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Cell Therapy Manufacturing Scientist
2 months ago
Net2Source Inc. is a distinguished total workforce solutions provider, recognized for our impressive growth trajectory and extensive global presence. We are committed to bridging the talent gap by delivering the Right Talent at the Right Time, in the Right Place, and at the Right Price while serving as Career Coaches to our consultants.
Position Title: Assistant Scientist
Location: Summit, NJ
Work Arrangement: 100% Onsite
Contract Duration: 12 months
Work Schedule: Monday - Friday, Business Hours
Role Overview:
We are in search of an Assistant Scientist to become a vital part of our Cell Therapy Manufacturing Team within the Cell Therapy Development division.
The Assistant Scientist will deliver technical and operational expertise to early-stage clinical manufacturing initiatives, focusing primarily on upstream processes while also supporting downstream operations in a single-use manufacturing setting.
Key Responsibilities:
- Oversee the full capacity of equipment and manufacturing operations, playing a crucial role during clinical processing.
- Collaborate in a team-oriented, cross-functional environment to fulfill production tasks as per the shift schedule.
- Support 5-S initiatives and ensure adequate supplies within the manufacturing suite.
- Adhere to production timelines to guarantee timely internal logistics.
- Document production data clearly and concisely, following proper Good Documentation Practices (GDP).
- Author manufacturing batch records, Standard Operating Procedures (SOPs), and material specifications.
- Engage in technology transfers from Cell Therapy Development and external partners, providing insights for manufacturing process implementation.
- Lead investigations into manufacturing processes, ensuring timely completion and communication of findings.
- Support routine data analysis to meet regulatory and compliance standards, including the preparation of technical reports.
- Drive process improvement initiatives, coordinating activities among team members.
Qualifications:
- Proven experience in the setup, operation, and control of single-use bioreactors and wave bioreactors.
- Knowledge in the formulation of culture media and buffer solutions.
- Hands-on experience with aseptic handling of mammalian cell cultures.
- Strong technical understanding of Cell Culture processes and equipment.
- Experience in operational planning, execution, and troubleshooting.
- Effective communication and project management skills suitable for leading technology transfer projects.
- Ability to work independently while representing the department in cross-functional projects.
- Excellent technical writing skills, with experience in drafting standard procedures.
- Capability to function well in both individual and leadership roles.
- Familiarity with DeltaV, cGMP, FDA/EMA regulations, and Process Validation.
- Preferably experienced in training and guiding peers on standard procedures.
- Experience in purification operations is a plus.
Educational Background:
- A bachelor's degree in Biochemistry, Bioengineering, Chemical Engineering, or a related field is required.
- Candidates will be evaluated based on their educational qualifications and relevant experience.
Working Environment:
- Ability to alternate between walking and sitting for job functions; prolonged sitting or standing may be necessary.
- Physical dexterity to operate computers and handle documentation.
- Capability to lift up to 50 pounds.
- Must be able to work in laboratories and controlled environments.
- Flexibility to wear clean room garments and personal protective equipment (PPE).
- Work in a clean room environment, which is a restricted space with specific pressure and temperature conditions.
Additional Requirements:
- Laboratory work without exposure to blood or animals.
- Position involves handling hazardous materials.
