“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to this company, its operations, or its staff.”
Top 3 Must Have Skill Sets:
Day to Day Responsibilities:
- Experience at cell culture operations, preferably mammalian cell culture (0-2 years experience)
- Understanding of GMPs, preferably having worked to GMP standards previously (0-2 years of experience)
- Statistic/chromatography exposure (0-2 years of experience) a plus
- soft skills
- Ability to work and plan work independently, and maintain documentation e.g. lab notebooks in a contemporaneous manner
- Technical writing (plus, not required)
- Cell culture operations to support pilot scale batch production and scale-down lab studies
- Preparation and performance of purification methods e.g. Ultrafiltration, Chromatography (incl column packing), filtration
- Routine periodic equipment maintenance e.g. cell counter calibrations, equipment cleans
The role is to provide process development lab support to process development operations for support and lifecycle development of a viral product.
Roles for the scientist include:
Production of live viruses at both bench and pilot manufacturing scales
Support for a GMP manufacturing process
Development of novel mammalian cell culture and next generation purification steps to increase yield and process robustness
The role is placed withinthis company Cambridge, MA (AMA) Oncolytic Virus PD team and will report directly to the PD Principal Scientist for this team.
Primary tasks and responsibilities include:
The successful candidate will apply fundamental scientific principles to Biopharmaceutical manufacturing processes (upstream cell culture and downstream purification) including:
A good understanding of mammalian cell culture processes; bioreactors, metabolism profiling, influence of raw material attributes and aseptic handling.
A good understanding of chromatography, ultrafiltration and normal flow filtration operations.
Familiarity with chemical engineering principles for the scale up of unit operations from bench scale to commercial scale. Understanding process capabilities and means to achieve yield optimizations and increased efficiencies.
- 0-2 years of experience in a Biotech/Pharma Process Development and/or Manufacturing Support role for drug substance manufacturing.
- Recent graduates from scientific background welcomed
- Able to apply engineering principles and statistical analysis, including design of experiments, in-order to solve processing issues and evaluate opportunities for process improvements
- Excellent written and verbal communication
- Ability to work under moderate direction.
- Able to analyze and interpret data
- Be a self-starter with the ability to take on several projects at one time
- Experience of GMP documentation and principles
Education: Bachelors Degree in Science related field
"This posting is for Contingent Worker, not an FTE"