Engineer/Sr Engineer - Technology Transfer

JOB SUMMARY

ReciBioPharm / Arranta Bio provides novel solutions for advanced therapies including RNA vaccines and therapeutics, plasmid DNA, and Live Biotherapeutics. We focus on new and emerging technologies that are reshaping healthcare. Our culture values agility, leadership, innovation, value-creation, and engagement within our teams, with our clients, and within our community.

We are seeking an Engineer/Sr. Engineer, Technology Transfer is responsible to leading the tech transfer, scale up, and GMP manufacturing of pDNA, microbiome, and/or mRNA/LNP products. The position is responsible for leading scale up and tech transfer of process from external sending unit to PD and to GMP manufacturing.  This includes execution of scale up and engineering batches, generation of batch documentation, and technical ownership of program operational readiness. 

ESSENTIAL JOB FUNCTIONS 

• Responsible for tech transfer of client processes into Arranta’s facilities. Perform facility analysis, author tech transfer documentation and lead engineering batch execution.
• Lead confirmation batches and scale up batches in partnership with Process Sciences and Manufacturing. Draft required documentation for execution of scale up batches.
• Lead execution of small scale and at-scale experiments to characterize equipment scale up and/or troubleshoot scale up and tech transfer challenges.
• Author/review/approve tech transfer documentation such as SOPs, process descriptions, protocols, and batch records.
• Provide on-the-floor SME support for Process Sciences and Manufacturing during tech transfer and batch execution.

• Chemical Engineering/Mechanical Engineering degree; advances degree will impact level within the organization
• Minimum 2 years’ experience in biotechnology and/or pharmaceutical manufacturing; years experience will have a direct impact on level of position
• Minimum of 2-5 years’ experience working in cGMP regulated environment, including working with change controls, deviations, and CAPAs.
• Hands on experience developing and scaling up fermentation, TFF, chromatography, and filtration processes
• Hands on experience leading tech transfer from internal and/or external partners.
• Experience with design, development, and procurement of single use technologies. Experience with the development of single use component flow diagrams (SUCFDs) and process flow diagrams (PFDs).
• Author/review SOPs, process descriptions, and batch records.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Adjusting or moving objects between 25lbs-50lbs
• Remaining in a stationary position (i.e., seated or standing if able) for prolonged periods
• Repeating motions that may include wrists, hands and/or fingers.