Frederick, Maryland, United States
Passionate and results-driven Production Manager in the biopharmaceutical industry with 15+ years of experience overseeing GMP manufacturing operations. I specialize in managing cross-functional teams, optimizing production processes, and ensuring regulatory compliance across all stages of biologics manufacturing. Whether working on clinical batches or commercial-scale operations, I focus on driving efficiency, product quality, and team performance. I thrive in fast-paced environments and enjoy building strong team cultures that prioritize safety, quality, and continuous improvement.
- Coaching, counseling, training/ development, discipline and recognition of direct staff, including performing annual performance reviews. - Initiates/ investigates deviations, and initiates CAPAs in correlation with deviations as needed. - Ensures performance of all process steps specific to the phase or stage of operation (upstream, downstream, support). - Coaches staff and intervenes during operations when required to achieve on-floor performance expectations. - Takes ownership of Tier 1, Tier 2, Tier 3, and shift change meetings to coordinate cross-functional resource allocation needs for issues identified and maintain production targets. - Executes production and resource schedules against operational plan when necessary. - Generates and updates SOPs, MPRs, and SPRs for equipment and procedures used in routine biologics manufacturing. - Monitors and creates documents and/ or spreadsheets to support business reporting requirements. - Completes final review of completed manufacturing documentation per compliance standards and established timeline. - Collaborates with Manufacturing process leads and Engineering to resolve problems, identifying root cause, and proposing process improvements through clear communication to senior management. - Participates and/ or leads multi-functional project teams, as necessary. - Participates in helping to evaluate and establish potential new interdepartmental procedures and practices.
- Provides input into annual performance evaluations of production technicians. - Investigates and resolves problems as they arise on the production floor. - In-direct supervision of production technicians. - Acts as a qualified trainer for new/ junior technicians. - Completes manufacturing documentation per approved procedures including reviewing documentation for completeness and accuracy per established timelines. - Assigns daily tasks to production technicians pertaining to manufacturing of biological based products. - Support other departments (engineering, automation) to improve or streamline current processes. - Coordinates production tasks to meet assigned schedule. - Lead Tier One meetings for Downstream-Purification teams. - Attend Tier 2 meetings to give updates on the status of downstream operations when necessary. - Uses knowledge of current cGMPs to determine how to proceed with operations if deviations occur and collaborate with MFG support personnel to find root causes for deviations as needed.
- Assisted with validating and qualifying new equipment. - Assisted with validating and qualifying clean room suites for production. - Assisted with assessing and reviewing contracts for ordering consumables. - Met with various clients (DOD, CDC etc.) to discuss future projects. - Trained Viral Diagnostics and Development group on downstream operations to include column chromatography, TFF and UF/DF. - Ordered equipment and reagents for viral vaccines as needed. - Trained on current SOPs, revised outdated SOPs and created new SOPs for procedures and new equipment. - Reviewed and revised current Batch Records and assisted in creating new batch records for various processes. - Was designated safety officer for viral vaccines and attended safety meetings and trainings for our division. - Attended meetings in place of department head when department head is absent or unable to attend. - Led various projects for DOD, ordered and acquisition of consumables and parts for all GMP departments. - Trained new/ onboarding technicians/ specialists as needed.
- Assisted with validating and qualifying new equipment. - Assisted with validating and qualifying clean room suites for production. - Assisted with assessing and reviewing contracts for ordering consumables. - Met with various clients (DOD, CDC etc.) to discuss future projects. - Trained Viral Diagnostics and Development group on downstream operations to include column chromatography, TFF and UF/DF. - Ordered equipment and reagents for viral vaccines as needed. - Trained on current SOPs, revised outdated SOPs and created new SOPs for procedures and new equipment. - Reviewed and revised current Batch Records and assisted in creating new batch records for various processes. - Was designated safety officer for viral vaccines and attended safety meetings and trainings for our division. - Attended meetings in place of department head when department head is absent or unable to attend. - Led various projects for DOD, ordered and acquisition of consumables and parts for all GMP departments. - Trained new/ onboarding technicians/ specialists as needed.
- Assisted in planning and participating in the execution of DSP manufacturing processes to produce vaccines and/or biologics. · Operated on a daily basis in IDT’s GMP vaccine manufacturing downstream areas, including buffer prep, purification and formulation suites. · Applied Scientific and mathematic principals to the design and execution of cGMP downstream purification processes. · Worked in in cleanroom and BSL-II facilities, and in the Process Development Laboratories as required for technology transfer purposes. · Operated and oversaw operation of mechanical equipment including AKTA Pilot and AKTA Process, Tangential Flow Filtration (TFF) system and Buffer Preparation systems. · Troubleshooted, cleaned and maintained process equipment. · Followed organizational health and safety guidelines while manipulation chemical, radiological, BSL-1 and BSL-2 hazardous materials. · Serves a technical support member for all client DSP projects. · Assisted in solving complex technical challenges. · Participated in all aspects of DSP operations including buffer preparation, column packing, filter sanitization, batch record generation and SOP generation. · Assisted in scale up and execution of non-GMP downstream manufacturing procedures. · Assisted in the resolution of Deviations, CAPAs, ICARs and led continuous improvement initiatives specific to DSP operations. · Supported CMO activities as needed.
- Validated and configured new HPLC systems and worked to implement and roll out operation within the production organization. - Developed new HPLC methods and modified existing methods to streamline and optimize processes. - Trouble shooted process and equipment issues and identified potential remedies to mitigate re-occurrence. - Reconfigured new and existing HPLC systems (Gilsons and AKTAs) to accommodate for process or method changes. - Conducted Downstream Chromatography of mRNA for preclinical targets using HPLC-based Chromatography solutions, focusing on increasing production capacity and decreasing turn around time. - Conducted in-process quality control assays to ensure mRNA are within defined specifications. - Identified operational bottlenecks and worked closely with operations, process development, automation, and informatics personnel to rectify. - Identified automation opportunities and help to co-develop solutions with the automation group. - Manually Perform Oligo dT to selectively purify a full length polyadenylated mRNA utilizing a vaccuum manifold. - Performed Hydroxyapatite Purification of mRNA utilizing an AKTA High Performance Liquid Chromotography (HPLC) system. - Performed Hydroxyapatite Purification using an automated "HA Bot". - Performed Final Buffer Exchange (Ultrafiltration) on mRNA utilizing a fully automated system, "UF Bot". - Performed Final Filtration on mRNA by utilizing a Hamilton Liquid Handler method for aliquotting and submitting final mRNA product to Quality Control (QC) and Inventory. - Wrote and revised Standard SOPs for downstream processes. - Utilized a Hamilton Liquid Handler method for alliquotting and performing spectrophotometry of mRNA. - Utilized a Fragment Analyzer, capillary electrophoresis system to analyze mRNA for purposes of identification and purity analysis. - Performed packing of Hydroxyapatite Columns for HA Chromatography. - Performed In Vitro Transcription and Capping for Large Scale RNA ops.