Manufacturing Associate II, Downstream Resume Stella Beck Manufacturing Associate II, Downstream (919) 555-7428 stella.beck@example.com linkedin.com/example/stellabeck Raleigh, NC 27609 STRENGTHS Downstream execution Column and filtration work stayed orderly during busy shifts, giving teammates a dependable point of reference for process decisions. Documentation discipline Real time EBR entries kept records clear and traceable, and peers sought help when documentation questions surfaced. Quality response Floor observations became useful investigation evidence, helping quality partners see what happened and what required follow up. Equipment readiness Readiness checks connected operator feedback with qualification work, making new equipment easier for teams to use safely. Team communication Shift handoffs covered open work, equipment status, and materials, so incoming operators could begin with fewer surprises. SKILLS cGMP Manufacturing Downstream Purification Column Chromatography Tangential Flow Filtration Viral Filtration Viral Inactivation In Process Sampling Aseptic Technique Electronic Batch Records Equipment Readiness Deviation Support Corrective Actions Operational Readiness Microsoft Office Team Communication LANGUAGES English Native 40 Spanish Intermediate 20 MY CAREER 5 Years Manufacturing Associate II, Downstream at Triangle Bioprocess Solutions (1.8 Years) Manufacturing Associate, Purification at Carolina Therapeutics Manufacturing (1.5 Years) Bioprocess Technician at Piedmont BioManufacturing Center (1.8 Years) SUMMARY Biopharmaceutical manufacturing professional with five years of regulated production experience supporting downstream purification, equipment readiness, cGMP floor execution, and electronic batch documentation. Hands on work includes column chromatography , column packing, tangential flow filtration , viral filtration, viral inactivation, conjugation fundamentals, final fill support, in process sampling , equipment cleaning, sanitization, and controlled manufacturing environments. Experience includes EBR/MES, Delta V, Electronic Quality Systems , SOPs, manufacturing procedures, JHAs, CFR expectations, aseptic practices, deviation initiation, investigation support, qualification activities, and production ramp up. NC BioWorks certified with a bachelor's degree in bioprocessing science. Consistently supports safe shift execution, accurate records, clear handoffs, and practical feedback that helps manufacturing teams protect quality, maintain readiness, and improve reliable biologics production. EXPERIENCE Manufacturing Associate II, Downstream Triangle Bioprocess Solutions January 2025 - Present Raleigh, North Carolina Supports clinical and commercial biologic intermediate production across downstream purification, electronic documentation, equipment readiness, qualification activities, and floor level quality response. Provides operator feedback during readiness work and helps production teams move safely from preparation through routine execution. Executed chromatography, TFF, viral filtration , and viral inactivation under approved cGMP procedures. Prepared single use and stainless steel equipment , confirming line clearance before manufacturing execution. Completed EBR/MES entries and monitored Delta V displays during critical process steps. Collected in process samples and operated designated analytical equipment with full traceability. Initiated deviations and quality events , supplying observations that supported investigations and corrective actions . Supported qualification checks for new downstream equipment, improving operator readiness during production transition. Manufacturing Associate, Purification Carolina Therapeutics Manufacturing June 2023 - December 2024 Durham, North Carolina Performed purification operations in a regulated biotechnology facility, supporting chromatography, filtration, buffer related steps, equipment care, electronic records, and shift readiness. Worked closely with manufacturing and quality personnel to keep controlled areas organized, documented, and prepared for continuing production. Prepared equipment and materials for chromatography, filtration, and buffer related process steps. Followed SOPs, manufacturing procedures, JHAs, gowning requirements, and cGMP documentation practices. Operated TFF and filtration equipment within defined parameters, recording observations in electronic records. Completed cleaning , sanitization , and washroom activities, maintaining controlled area readiness. Provided contemporaneous records and equipment status for deviation fact gathering activities. Communicated open tasks, equipment conditions, and material needs during shift handoffs. Bioprocess Technician Piedmont BioManufacturing Center August 2021 - May 2023 Research Triangle Park, North Carolina Supported supervised cGMP bioprocess operations through area preparation, component staging, equipment setup , downstream processing support, sampling, documentation, and contamination control. Progressed through structured training toward independent execution of qualified technician tasks while preserving safety, traceability, and record accuracy. Prepared manufacturing areas and staged components under qualified procedures and operator oversight. Supported column preparation, chromatography workflows, filtration, and controlled material transfers. Maintained paper and electronic records, correcting documentation issues through approved practices. Performed routine cleaning and sanitization while applying gowning and contamination control expectations. Collected in process samples and preserved identification, timing, and traceability requirements. Completed structured training in safety, quality, cGMP behavior, and equipment operation . PROJECTS Downstream Equipment Readiness Program 2025 Supported readiness checks for new downstream equipment, combining operator feedback, approved verification steps, and practical floor preparation for reliable manufacturing use. Electronic Batch Record Accuracy Initiative 2024 Improved daily documentation discipline through timely EBR entries, clear shift communication, and careful review of process observations before handoff. LEADERSHIP & AWARDS NC BioWorks Certification Program completion, 2021 Recognized for safe cGMP execution and dependable downstream production support Selected to support equipment readiness and qualification activities during production ramp up EDUCATION Bachelor's Degree in Bioprocessing Science North Carolina State University GPA: 0 2021 Raleigh, North Carolina Coursework: Biopharmaceutical manufacturing, downstream processing, cGMP operations, process analytics CERTIFICATIONS NC BioWorks Certification Program 2021 Bachelor of Science, Bioprocessing Science 2021 TECHNICAL SKILLS Downstream Processing: Column Packing, Column Chromatography, Tangential Flow Filtration Viral Processing: Viral Filtration, Viral Inactivation, Conjugation Manufacturing Systems: EBR, MES, Delta V Quality Systems: Electronic Quality Systems, Deviations, Investigations GMP Documentation: SOPs, Manufacturing Procedures, JHAs Equipment Operations: Single Use Systems, Stainless Steel Equipment, Analytical Equipment Facility Readiness: Commissioning, Qualification, Operational Readiness Cleaning Controls: Cleaning, Sanitization, Washroom Operations Aseptic Operations: Gowning, Aseptic Technique, Contamination Control Compliance Standards: cGMP, CFR Compliance, Controlled Manufacturing Manufacturing Records: Electronic Batch Records, Paper Records, Sample Traceability Process Support: In Process Sampling, Process Monitoring, Final Fill Support SKILLS cGMP Manufacturing Downstream Purification Column Chromatography Tangential Flow Filtration Viral Filtration Viral Inactivation In Process Sampling Aseptic Technique Electronic Batch Records Equipment Readiness Deviation Support Corrective Actions Operational Readiness Microsoft Office Team Communication PROFESSIONAL AFFILIATIONS NC BioWorks professional certification community Bioprocess manufacturing and downstream operations community North Carolina State University bioprocessing alumni network LANGUAGES English (Native) Spanish (Intermediate) ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. ADDITIONAL INFORMATION Work Status : Authorized to work in United States. No sponsorship required. REFERENCES AVAILABLE ON REQUEST
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