Company Overview:
Our client is a global leader in the life science and biotech sphere, located in the Southern New Hampshire area. They are committed to discovering and developing innovative solutions to complex issues to improve the lives of millions of people and businesses worldwide.
Job Overview:
Our client is seeking to bring on several MSAT Process Engineers and/or Scientists at various levels dependent on experience to help build out their upstream processing team. In this position, one can expect to be a Subject Matter Expert (SME) for upstream processes. We are looking for individuals well-versed in Upstream aseptic technique, mammalian cell culture, and technology transfer to work in-lab 1 to 2 days a week, based on the hybrid schedule model currently in place.
Key Responsibilities:
- Ability to represent the MSAT on projects as a Subject Matter Expert (SME) and interface with quality representatives.
- Ability to work with bioreactors, preferred large scare bioreactors (2kL).
- Ability to monitor and report on manufacturing performance data and deliver reports in-person based on data analysis and finds.
- Able to develop process understanding.
- Author change controls.
- Creating change controls and authoring batch records
- This role will NOT have direct reports as this is an individual contributor position.
Qualifications:
- Minimum education requirement is a Bachelor of Science, preferred in Biological Sciences. Chemical Engineering, or Biotechnology
- Proven knowledge on the topics of aseptic technique and mammalian cell culture
- Hands on experience with cell biology, scale up and mass transfer, cell culture, bioreactor operation, statistical data analysis, and disc stack centrifugation.
- A background in biotech, tech transfer and/or manufacturing, process scale up, and process development.
- Experience with large scale (2kL) bioreactors preferred.
- Experience with mammalian manufacturing support preferred.
- Able to adhere to cGMP and US EU regulations.
- Able to share 24/7 on-call support while in manufacturing stages.
This is a full-time position with competitive compensation and benefits. If you are a results-driven leader with a passion for improving patient lives and a proven track record of success in engineering and facilities management, we encourage you to apply.
