Associate Scientist


Posted: 07/20/2022 Job Number: 21183731

Job Description

Occasional weekend work required, paid as OT.

Project Description:
  • 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.
  • 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.

Required Skills:
  • 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 + 0-2 years relevant experience in manufacturing operations of Biotech / Biopharm industry .
  • Associate Scientist BA/BS + 2-4 years or MA/MS + 0-2 years 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.

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 25 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.

This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Angie: angie@alphaconsulting.Com


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Angie Dawn

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