We are seeking a highly motivated Senior Biomedical Engineer who is interested in joining our fast-paced, dynamic environment.
This position is responsible for applying biomedical engineering expertise and technical leadership to effectively deliver cell therapy manufacturing development services to clients, including planning and execution of process development and manufacturing engineering projects in accordance with defined scope of work, timelines, and budgets contracted with clients. This position is based in Allendale, NJ.
Responsibilities:
Design and perform studies with devices, systems, and techniques, such as automation, for isolating, manipulating, culturing, and formulating human cells
Execute projects in alignment with pre-planned scope of work, timeline, and budget.
Serve as Subject Matter Expert, provide technical project management, and technical team oversight
Collaborate with adjacent functions, e.g. Innovation and Engineering, Manufacturing Support/Tech Transfer
Provide general engineering support and present results and updates at internal and client project team meetings and external meetings and conferences
Write technical documents such as protocols, reports, SOPs, work instructions, white papers, publications
Perform work within the content of relevant industry practices such as, Quality by Design (QbD) and Good Manufacturing Practices (GMP)
Education and Experience:
Advanced degree in relevant engineering discipline (chemical, bioprocess, or biomedical), or Bachelor’s degree with equivalent experience.
Minimum of 3 years of experience in a manufacturing development environment for biologics, preferably cell therapy products
Wet lab experience, preferably in cell and tissue culture, cell isolation/enrichment, cellular function assays, bioreactors
Prior experience with process automation preferred
Candidate Profile:
Aligns with the core values of the company
Strong collaborative leadership style
Strong influencing skills and ability to work well in a cross-functional, matrixed environment
Flexible and able to adapt to company growth and evolving responsibilities
Structured approach to thinking and planning
Analytical and problem solving skills with innovation-seeking mindset
Strong communicator and listener
Can-do attitude
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