As 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 Champion full capability of equipment capacity and manufacturing operations to lead and support manufacturing operations. Function as a core member during clinical processing. Wo... more details
Kelly is hiring for an Assistant Scientist position with one of our clients in Summit, NJ.
Full time- W2
12 months contract (May be extended or converted)
$33/hr
Job Description: As 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
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 and Education Requirements:
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.
Assistant Scientist – BA/BS + 0-3 yrs relevant experience in manufacturing operations of Biotech / Biopharm industry
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.
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.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please apply online to be considered for the position. As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. That’s why we’re proud to offer a complete array of voluntary benefits to members of the Kelly talent community. Apply Today! #P2
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