Job Description: 100% onsite
work schedule- M-F normal business hours
Position Description:
We are currently looking for an Assistant Scientist to join our Cell Therapy Manufacturing Team within the Client's Cell Therapy Development group in Summit, New Jersey.

s a member of the Cell Therapy Development group, the Assistant Scientist will provide technical and operational expertise and oversight to early-stage clinical manufacturing campaigns. The focus of this position will be on upstream operations and support of downstream operations in single-use manufacturing environment.

s appropriate, responsibilities include but not limited to:

- Champion full capability of equipment capacity and manufacturing operations to lead and support manufacturing operations. Function as a core member during clinical processing.
- Works in a team based, cross-functional environment to complete production tasks required by shift schedule.
- Support 5-S efforts and maintain adequate manufacturing suite supplies.
- Adheres to the production schedule ensuring on-time, internal production logistics.
- Records production data and information in a clear, concise, format according to proper GDPs.
- Author manufacturing batch records, SOPs, material specifications, etc.
- Participate in technology transfers from Cell Therapy Development and external partners to within network. Technology transfer will include providing decisions for manufacturing implementation of processes and communicating the decisions to the technology transfer team.
- Lead manufacturing investigations toward process impact assessments and ensuring timely completion and communications. Responsible for identifying appropriate CAPA(s) and implementation of them.
- Support routine data trending of manufacturing data to fulfill regulatory/compliance requirements. This includes authoring various technical reports.
- Leads process improvement efforts of significant scope, involving coordinating activities of other team members.

Qualifications:
- Demonstrated skills in setup, operation, and control systems of single-use medium to large scale bioreactors and wave bioreactors
- Demonstrated skills in formulation of culture media and buffer solutions.
- Hands-on experience in aseptic handling of mammalian cell cultures.
- Strong technical knowledge related to Cell Culture process and equipment (i.e. Bioreactors, wave reactors, media and harvest vessels, related analytical equipment, and process control software).
- Demonstrated experience in operational planning, operational execution, and troubleshooting.
- Good communication and project management skills appropriate for leadership of technology transfer projects.
- Experienced with working independently and representing the department to lead cross-functional project execution.
- Excellent technical writing skills, with significant experience writing standard procedures.
- Ability to work well in both individual and leadership capacities
- Knowledge of DeltaV, cGMP, FDA/EMA regulations, Process Validation
- Preferably experienced with training and leading peers on standard procedures.
- Preferably has proficiency in purification operations.

Education:
- Required bachelor's degree in Biochemistry, Bioengineering, Biochemical, Chemical Engineering or related discipline
- Candidates will be considered for the applicable position based on education and level of experience.
o Assistant Scientist - BA/BS 0-3 yrs relevant experience in manufacturing operations of Biotech / Biopharm industry
Working Conditions:
- Intermittent walking and sitting to perform job functions; however, ability to sit or stand for extended periods of time may be necessary.
- Physical dexterity sufficient to use computers and documentation.
- Ability to lift up to 50 pounds.
- Must have the ability to work around laboratories and controlled, enclosed, restricted areas.
- Flexibility to don clean room garments and personal protective equipment (PPE).
- Clean room environment is an enclosed, restricted space, with assigned pressure and temperature conditions. Reagents, chemicals, and exposure to sanitization agents are expected.
dditional Job Requirements:
Lab w/o blood & animal
Position Handles Hazardous Materials