Bioprocess Engineer

Phil Ellis Associates, Inc.; Kildare Estates (AL); On-site; USD 80,000 - 120,000; Full time

Benefits offered by this job

Competitive salary

Bonus

Stock options

Relocation assistance

Benefits

Job summary

Phil Ellis Associates, Inc. is seeking an experienced leader to oversee pilot scale downstream processing of plasmid DNA in Kildare Estates, Alabama. The successful candidate will manage process development, establish a GMP facility, and ensure robust process documentation.

Applicants should possess a B.S. or M.S. degree in Biochemical or Chemical Engineering and have over four years of hands-on experience in biopharmaceutical manufacturing. A competitive salary, bonus, stock options, and benefits are included.

Qualifications

• 4+ years of biopharmaceutical experience with plasmid DNA processing.
• 2+ years in a GMP manufacturing environment preferred.
• Experience in validation protocols for IQ, OQ, and PQ.
• Hands-on experience with TFF in DSP operations.

Responsibilities

• Lead pilot scale downstream processing of plasmid DNA.
• Plan and execute process development experiments.
• Establish new GMP manufacturing facility.
• Document work and translate processes into SOPs.

Skills

Biochemical/Chemical Engineering

Process optimization

GMP manufacturing

Bioreactor fermentation

Ultrafiltration/Diafiltration

Ion exchange chromatography

Education

B.S. or M.S. in Biochemical/Chemical Engineering

Job description

Job Description

• Lead the development of pilot scale downstream processing (DSP) unit operations of plasmid DNA from bacterial cell paste (from 10 L - 100 L bioreactor fermentation), to include lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
• Plan and execute structured process development experiments to achieve the target yield, process optimization, product quality, scale-up and process robustness objectives.
• Play a pivotal role in the establishment of a GMP manufacturing facility to produce plasmid DNA active pharmaceutical ingredient (API).
• Document work thoroughly with a detail‑oriented approach, write concise technical reports, and make effective presentations to management and other team members.
• Translate developed processes into standard operating procedures (SOPs) as well as necessary calibration and preventive maintenance SOPs.
• Write validation protocols and lead the technical support staff to successfully execute IQ, OQ, and PQ.
• Lead the process transition into the new facility.
• Troubleshoot, optimize, and improve ongoing process activity with scientific curiosity.

Qualifications

• B.S. or M.S. degree in Biochemical/Chemical Engineering preferred. Will also consider other disciplines such as biology, chemistry, or related field with requisite experience.
• 4+ years of hands‑on biopharmaceutical experience at pilot or commercial scale with bioreactor fermentation (USP) and DSP of plasmid DNA from bacterial cell paste, including lysis, clarification, ultrafiltration/diafiltration, and ion exchange chromatography.
• 2+ years of experience working in a GMP manufacturing environment. Candidates with supervisory experience are preferred.
• Significant experience using ultrafiltration and diafiltration with tangential flow filtration (TFF) in a DSP unit operation.

Additional Information

Competitive salary, bonus, stock, relocation and benefits are offered.