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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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly ® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we’re obsessed with where it can take you. To us, it’s about more than simply accepting your next job opportunity. It’s the fuel that powers every next step of your life. It’s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.