Akron Bio · 2 weeks ago
MSAT Process 1 Engineer
Boca Raton, FL
Full-time
Onsite
Mid, Senior Level
5+ years expAkron Biotech is seeking highly motivated professionals to join their expanding team, playing a critical role in advanced therapy development and commercialization. The MSAT Process 1 Engineer will guide the execution, resources, business processes, and tech transfer for the MS&T department, collaborating with teams to ensure efficient project execution.
BiotechnologyHealth CareManufacturing
Responsibilities
Technical responsibility for New Product Introductions and Technology Transfers with external partners and internal site
Drive NPI portfolio technical robustness from feasibility to launch with support of site and external partners, data review and results interpretation
Support technical projects to ensure a successful start-up, improve process control, yield, product quality and/or productivity. Implement process changes and improvements through the technical agenda
Perform investigations, support risk management in relation to products and drive process improvement initiatives
Author and approve technical protocols and reports, Change Controls, SOPs, Batch Records for site operations
Represent the department during audits, client meetings and multi-disciplinary meetings with clients and upper management
Participate multi-disciplinary projects to improve manufacturing operations, adopt new technologies, increase productivity, reduce cost of goods, streamline practices
Ensure that related SOPs describe the process as performed and the control strategy for the discrete manufacturing steps
Develop, monitor, and appropriately respond to proactive process monitoring including statistical analysis in JMP
Qualification
Required
Bachelor in a science or bioengineering field with a minimum of 5 years industry experience, at least 2 of which include technical operations experience, or Masters/ PhD with 2 years industry experience that include technical operations
Broad technical exposure in diverse areas including recombinant protein manufacturing, human plasma processing, formulation development, and/or aseptic processing
Previous experience with technology transfer is required
Strong GMP experience as well as technical and communication skills: oral/written
ISO 13485:2016, 21CFR or similar experience
Experience with JMP/MiniTab or equivalent statistical software
Preferred
Project/ Portfolio Management is preferred
Lean Manufacturing Experience, Green or Black belt preferred
Benefits
Highly competitive benefits and perks
Company
Akron Bio
We support the advancement of cell and gene therapies through our portfolio of cytokines and media supplements, along with a comprehensive suite of manufacturing services—including the production of proteins, media and buffers, and transfection and transduction reagents.
51-200 employees
H1B Sponsorship
Akron Bio has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
Funding
Current Stage
Growth StageTotal Funding
unknown2019-09-11Acquired
Leadership Team
Christopher Murphy
Chief Executive Officer
Cameron Oden
Chief Financial Officer
Recent News
2025-05-05
Google Patent
2025-02-16
Company data provided by crunchbase