Assistant Scientist

Innova Solutions is immediately hiring an Assistant Scientist

Job Title : Assistant Scientist

Position type : Full-time Contract

Duration : 12 Month

Location : Summit, NJ

Pay range : $ 30 -$ 35.56 / Per Hour

As an Assistant Scientist , you will :

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.
• Assistant Scientist - BA / BS + 0-3 yrs. relevant experience in manufacturing operations of Biotech / Biopharma 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.

Thank you!

Sara Almas

Team Recruitment

PAY RANGE AND BENEFITS :

Pay range : $ 30 -$ 35.56 / Per Hour

Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits : Innova Solutions offers benefits( based on eligibility) that include the following : Medical & pharmacy coverage, Dental / vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).