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Associate Scientist (Virus Protection)

GENERAL DESCRIPTION/FUNCTION:

This role is responsible for supporting the overall GMP virus production process, through the application of broad knowledge of theories and principles utilized to solve operational, as well as routine tasks in the production of virus-based recombinant vaccines. This individual functions independently and productively as a Virus Production Associate and is actively engaged in process and product development within a dynamic project team. Displays strong technical knowledge, initiative and scientific commitment, and makes significant scientific and technical contributions within Virus Production and Process Development Groups.

Duties & Responsibilities:

Leveraging experience and knowledge of virology, viruses/VLPs, cell culture, bioprocess engineering, and recombinant protein expression, the focus of this role will include:

Deploying virology techniques including isolation, propagation, expansion, optimization of virus infection kinetics
Ensuring the use of aseptic technique, and cell propagation in T-flasks, cells tacks and WAVE reactors
The propagation of viruses at bench and large scale using disposables and bioreactors
Primary recovery of viruses from production cultures
Participates in decision-making processes within the project team by actively engaging in scientific and technical discussions
Creating, revising, and editing SOP, SMPs, and specs as needed
Reviewing PD materials, equipment, methods for GMP compliance and scalability
Building credibility within the lab group by performing high quality work
Expanding the technical capabilities of the GMP Group
Working efficiently with Process Development to solve scale-up challenges
Working diligently on documentation to meet GMP timelines
Effectively communicating results of own work through discussions and documentation with some input from supervisor
Other duties as assigned

Skills & Technical Expertise:

Has considerable knowledge/expertise relevant to fundamental lab technologies, particularly focused on virology, viruses/VLPs, cell culture, bioprocess engineering, and recombinant protein expression
Practical experience with single-use disposable equipment applications for typical operations used in biomanufacturing
Knowledge and experience in aseptic technique, and cell propagation in T-flasks, cells tacks and WAVE reactors
Experience with large scale cell culture at scales up to or beyond 15 liters
Strong understanding of FDA regulatory requirements associated with analytical characterization and documentation of vaccine products; cGMPs
Knowledge/expertise should be practical and focused on lab-related activities
Knowledge of process characterization and process validation of biological products
Excellent record keeping abilities to adequately record, analyze and document, should be able to construct batch records, SOPs, SMPs, and specifications for production
Responsible for time management with regard to support documentation generation in Process Development to support later GMP production.
Flexibility in following projects from Process Development, scale up, technology transfer and to GMP
Document writing, data interpretation, presentation, statistical analysis and trending a plus

Supervision:

Modest supervision required on day-to-day activities and accomplished tasks
Reviews new assignments with supervisor
Supervisory input focused on status and future of project or technical area and long-term development path

Measurement of Performance:

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to a project team
Timeliness and accuracy in completion of projects and paperwork (quantity of work)
Contributions to projects beyond general responsibilities (quality of work)
Identification of problem areas affecting operations (knowledge/problem solving)
Offers suggestions for correcting problems and for improving operations
Exercises good judgment in dealing with operational problems
Understanding of theory, rationale behind tasks performed
Demonstrated understanding and adherence to our client’s policies, safety procedures and the cGMPs
Ability to succeed in a team-oriented environment under very dynamic conditions

Education & Previous Experience:

S. in Biology, Chemistry, Life Sciences or related field plus 3 – 8 years of relevant experience – OR –
S. in Biology, Chemistry, Life Sciences or related field plus 1 – 3 years of relevant experience
Experience working in Pharmaceutical or biotechnology industry or academia desirable
The ability to work in team oriented environment is essential, as this person will work closely with other members of Virus and Process Development groups and participate on multidisciplinary project teams

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