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We currently have an opportunity for a scientist to join our team in Varicella bulk vaccine manufacturing, within the Client Manufacturing Division (MMD), supporting a new PAT (process analytical technology) lab and laboratory operations. A successful candidate must have problem-solving and troubleshooting skills, as well as an interest in understanding how cell expansion and viral propagation impact the manufacturing process and vice versa. In this role, the candidate will take responsibility for routine assay execution, laboratory maintenance, maintaining GMP documentation, and proactive process and assay monitoring of the Varicella zoster virus propagation process. Furthermore, the candidate must be able to work efficiently in a high paced environment, collaborate well with others, and have excellent interpersonal skills. Note: The ability to work a flexible, rotating shift schedule, which will be predominantly nights and weekend coverage, will be required based on manufacturing process support needs. Primary activities include but are not limited to the following: • Conduct a real-time flow cytometry assay in support of increased manufacturing process control and consistency in viral growth kinetics. • Participate in the transfer of process analytical technologies (PAT) to cGMP manufacturing facilities, and support implementation and operations in the new PAT laboratory. • Support routine laboratory operations, cleaning, supply ordering, and preventative maintenance. • Support proactive process monitoring through assay and process data collection, GMP laboratory experiments (e.g., viral growth curves), etc. • Characterize existing processes, identify key sources of variability, and identify potential process improvements. • Conduct laboratory experiments to support technical investigations and implement sustainable long term solutions
Required Experience/Skills: • The ability to work a flexible, rotating shift schedule, which will be predominantly nights and weekend coverage, will be required based on manufacturing process support needs. • BS in life science (e.g., biology, microbiology, immunology, virology, etc.), or engineering (e.g., biomedical, chemical). • Must have excellent communication, documentation, and interpersonal skills; as well as strength in data analysis/interpretation, and the ability to exercise scientific judgment for real-time decision-making. • Strength in technical troubleshooting and problem solving, as well as superior result reporting skills (i.e., presentation of results, impact, and recommendations). • Must be able to work both independently and within multi-functional teams in a fast-paced environment. Ability to work with little supervision and manage/differentiate ambiguous situations is important. • Must be willing to be vaccinated and achieve, and/or blood tested for titer against the Varicella (chickenpox) virus. Desired Experience/Skills: • Experience with flow cytometry and/or performing immunoassays is preferred. Experience in analytical testing utilizing a variety of biochemical, molecular, and cell biology techniques. • Experience in laboratory operations including GMP documentation, equipment maintenance, and scheduling. • Experience with cell culture and aseptic techniques. • Good general industrial process knowledge and experience with cGMP manufacturing and/or large-scale production.
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