Scientist

Title: Scientist - II (Associate)

Location: Elkhorn, NE

Duration: 12 months

Job Description:

Our Manufacturing teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates, and finished products. The function of Scientist at Biotechnology and Solutions (BTS) – process development (PD) will have a focus in Vaccine and Biologicals processes development for Manufacturing. BTS Pd team is responsible for new products process development and tech transfer. Within a multidisciplinary environment you will cooperate with your colleagues at BTS site support, Manufacturing, Engineering, Quality and R&D. Your main field of attention is to provide all round technological support on Vaccine and Biologicals Manufacturing of new (R&D) products.

Responsibilities:

• Works independently as a team member on the development and scale up of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics.

• Works independently as a team member on the transfer of processes or technologies of microbial, virus and cell cultivations, biomolecules concentration and purification and final formulation of veterinary vaccines and therapeutics to the production lines.

• Works independently as a team member on the development of processes or technologies and its transfer to the production lines within the timelines set for this purpose, whereby these processes and technologies meet the requirements of the customer with regard to safety, quality, cost-efficiency, practical applicability and consistency.

• Works independently as a team member on technical investigations, validation and/or process improvement projects.

• Examine issues from diverse perspectives (safety, compliance, automation, equipment, process and people) in order to best understand and resolve the root cause.

• Whether or not in collaboration with team members from other departments (e.g. QC, BTS, Pharmaceutical Technical Support, R&D, Production or Analytical Technical Services) gives direction to scientifically based decisions within projects aimed at the improvement of products, solving problems or development of new products.

• If necessary, performs development, introduction and/or testing of new technologies.

• Collaborates and interfaces with R&D and Manufacturing and other departments to bring new products to the market.

• Works within large cross-functional teams and demonstrates working knowledge of current USDA regulatory guidelines and advanced technical knowledge.

• Develop project charters and project plans and align with all sponsors and stakeholders.

Key capabilities include standard project management activities:

Development of timelines, use of project tracking tools, definition of deliverables, definition of roles and responsibilities, risk identification tracking and mitigation.

• Coordinates and tracks team activities by leading or participating in core team meetings, communicates project risks and status to appropriate stakeholders and escalates issues to sponsors as needed in advance of deviation from project plans.

• Assures consistent application of standardized work, engineering and process tools.

• Conducts and designs experimental protocols as needed using the R&D lab facilities and/or production equipment at full scale.

• Creates and updates technical and manufacturing documents necessary for investigations, process design/definition, engineering studies, process demonstrations, change control and validation.

• Displays our Company's leadership behaviors and demonstrate a high emotional intelligence.

• Effectively collaborates with peers on site and above site as required. Contributes to international projects (Global Projects).

• Interact closely with fellow scientists from your own and other departments. If required with external collaboration partners.

• Actively contributes to the improvement or acceleration of activities within the department, also in the field of Environment Health and Safety.

• Trains and guides employees and / or trainees.

Quals--

Education Minimum Requirement:

• Bachelor’s degree in Biochemical Engineering, Biotechnology, Chemical Engineering, Biology, Biochemistry, Protein Chemistry, Microbiology 4 years’ experience in vaccine/biopharmaceuticals Research and Development, Process Development and/or biological manufacturing or closely related field or Master degree 3 years’ experience or PhD with 1 in related field.

Required Experience and Skills:

• Cell culture techniques.

• Aseptic techniques.

• Virology

• Excellent written and oral communication skills.

• Excellent teamwork skills.

• Strong problem-solving skills and a hands-on approach to solving problems inclusive of diverse perspectives (e.g. safety, compliance, manufacturing).

• Can work together in multidisciplinary and international teams.

Preferred Experience and Skills:

• Experience in bioprocess scale up and vaccine manufacturing.

• Working knowledge of USDA regulations.

• Knowledge of GMP requirements for manufacturing and testing of biological products.

• Understanding statistics and application to process monitoring and control.

• Excellent project management, documentation and writing skills.

Notes:

• WORK LOCATION: ELKHORN, NE

• 100% onsite role.

• 12 months assignment with possibility of extension.

• Performs off-shift work (only as needed).