RoosterBio is looking for a Scientist for its Product Development team. The ideal candidate is self-starting, friendly, well organized, highly motivated, and dedicated to driving significant change in how RegenMed products are developed and commercialized. This individual will focus on research and development of hMSC-based products, with a special focus on incorporating genetic engineering and extracellular vesicle technologies into hMSC product development. This position is critical to the RoosterBio business with responsibilities in product development including tech transfer to cGMP manufacturing. These responsibilities are central for producing high quality products for our customers and to ensure a good experience with our products. The successful candidate will contribute to RoosterBio’s development team to advance MSC technologies, while enhancing our work culture. The candidate will work cross functionally within RoosterBio to support all product development / tech transfer activities.
- Design, execute, and analyze development experiments for RoosterBio product development efforts with a focus on rapid clinical/cGMP translation.
- Design prototypes and develop new products for hMSC cell manufacturing.
- Work with CMOs on technology transfer of new products/processes in cGMP environment.
- Create novel product and process concepts to contribute to the company’s IP portfolio.
- Identify, evaluate, and integrate new equipment, processes technology, and critical process parameters for use in laboratory and industrial scale operations.
- Generate and document critical data and records from development studies in technical reports and help to support the CMC of RoosterBio product FDA Master Files.
- Compile, manage, analyze, present data, as well as author technical reports.
- Take ownership of projects and effectively communicate project data and progress to the team.
- Collaborate with team members and other departments (Operations/QC/QA/Regulatory) to support and solve technical challenges.
- Work on prioritized projects and efficiently execute to achieve goals within dedicated timeline.
- Collaborate with sales and marketing to provide support for existing and new products.
- Draft, review, and update Batch Records and Standard Operating Procedures as needed.
- Assist on lab maintenance and perform additional duties as needed.
- PhD in Chemical/Biomedical Engineering, or other biological discipline with 0-3 years of relevant industry experience, or Master’s degree with 5-10 years of experience
- Experience in adherent mammalian cell culture, and aseptic techniques.
- Experience with MSCs (Mesenchymal Stem/stromal cells), EVs (Extracellular Vesicles), stem cells, genetic engineering, biotechnology, and regenerative medicine.
- Basic knowledge of cell manufacturing principles, risk assessments (FMEA), Chemistry, Manufacturing, and Controls (CMC) principles, and tech transfer is a plus.
- Action oriented, results driven, and able to accomplish project objectives and meet or exceed expectations.
- Excellent oral and written communication skills
- Ability to perform studies accurately and reproducibly.
- Ability to work on multiple projects and effectively contribute to the team.
- Adapts to changes, demands, schedules, and priorities while maintaining a positive attitude.
- Accepts personal responsibility for producing results (individually and as a team).
- Exhibits a high level of professionalism at the workplace.
- Candidate must be eligible to work in the U.S for other than practical training.
You can find the link here: https://www.roosterbio.com/about-us/careers/