Columbia Consulting Group Hiring for Assistant Scientist at Summit, NJ Full Time

Assistant Scientist

We are currently looking for an Assistant / Associate Scientist to join our Biologics Manufacturing Team within the Biologics Development & Manufacturing group in Summit, New Jersey.
As a member of the Biologics Development & Manufacturing group, the Assistant / Associate 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.

As 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.
• 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 Biologics 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:

• 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 + 0-2 yrs relevant experience in manufacturing operations of Biotech / Biopharm industry
o Associate Scientist – BA/BS + 2-4 yrs or MA/MS + 0-2 years relevant experience in manufacturing operations of Biotech / Biopharm industry

Job Type: Contract

Pay: $42.00 per hour

Schedule:

• 8 hour shift

Work Location: One location