Cell Therapy Manufacturing Assistant Scientist
2 weeks ago
Net2Source Inc. is a distinguished total workforce solutions provider, acknowledged by Staffing Industry Analysts for our remarkable growth of 300% over the past three years, boasting a workforce of over 5500 employees globally and more than 30 locations across the United States, with operations in 32 countries. Our mission is to deliver staffing solutions that bridge the current talent gap – Right Talent – Right Time – Right Place – Right Price, while also serving as a Career Coach 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 seeking an Assistant Scientist to become an integral part of our Cell Therapy Manufacturing Team within the Cell Therapy Development division. This role is pivotal in providing technical and operational guidance during early-stage clinical manufacturing processes, with a primary focus on upstream operations and support for downstream activities in a single-use manufacturing environment.
Key Responsibilities:
- Oversee the full capacity of equipment and manufacturing operations, acting as a core member during clinical processing.
- Collaborate in a team-oriented, cross-functional setting to fulfill production tasks as per the shift schedule.
- Support 5-S initiatives and ensure adequate supplies within the manufacturing suite.
- Adhere to production schedules to guarantee timely internal production logistics.
- Document production data clearly and concisely in accordance with Good Documentation Practices (GDP).
- Draft manufacturing batch records, Standard Operating Procedures (SOPs), and material specifications.
- Engage in technology transfers from Cell Therapy Development and external partners, making decisions regarding manufacturing process implementation and communicating these to the technology transfer team.
- Lead investigations into manufacturing processes, assessing impacts and ensuring timely completion and communication of findings. Identify and implement appropriate Corrective and Preventive Actions (CAPA).
- Conduct routine data trending of manufacturing data to meet regulatory and compliance standards, including authoring various technical reports.
- Drive process improvement initiatives of significant scope, coordinating activities among team members.
Qualifications:
- Proven expertise in the setup, operation, and control of single-use medium to large-scale bioreactors and wave bioreactors.
- Experience in formulating culture media and buffer solutions.
- Hands-on proficiency in aseptic handling of mammalian cell cultures.
- Strong technical understanding of Cell Culture processes and equipment (e.g., Bioreactors, wave reactors, media and harvest vessels, related analytical equipment, and process control software).
- Demonstrated 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 project execution.
- Exceptional technical writing skills, with significant experience in drafting standard procedures.
- Capacity to excel 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.
- Preferably possesses proficiency in purification operations.
Educational Background:
- A bachelor's degree in Biochemistry, Bioengineering, Biochemical Engineering, Chemical Engineering, or a related field is required.
- Candidates will be evaluated for the position based on their educational qualifications and relevant experience.
- Assistant Scientist - BA/BS with 0-3 years of relevant experience in manufacturing operations within the Biotech/BioPharm industry.
Working Conditions:
- Involves intermittent walking and sitting; ability to remain seated or standing for extended periods may be necessary.
- Physical dexterity is required for computer use and documentation.
- Must be able to lift up to 50 pounds.
- Ability to work in laboratories and controlled, enclosed, restricted areas is essential.
- Flexibility to wear clean room garments and personal protective equipment (PPE) is required.
- Clean room environment is a restricted space with specific pressure and temperature conditions; exposure to reagents, chemicals, and sanitization agents is expected.
Additional Job Requirements:
- Lab environment without blood and animal handling.
- Position involves handling hazardous materials.
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