Stephanie Bartke Email & Phone Number

Loveland, Colorado, United States

-Leads and manages interdisciplinary project teams related to the operational processes (facilities strategy, warehouse transfers, process development, manufacturing transfers from R&D to mfg and between facilities/projects, of veterinary in-house diagnostics)-Responsible for day-to-day execution of projects, ensuring on-time delivery within budget-Monitor, track, and report out the effectiveness and performance of assigned projects, all the while ensuring compliance with internal and… Show more -Leads and manages interdisciplinary project teams related to the operational processes (facilities strategy, warehouse transfers, process development, manufacturing transfers from R&D to mfg and between facilities/projects, of veterinary in-house diagnostics)-Responsible for day-to-day execution of projects, ensuring on-time delivery within budget-Monitor, track, and report out the effectiveness and performance of assigned projects, all the while ensuring compliance with internal and regulatory requirements.-Assist and develop continuous improvement/lean initiatives-Maintains dashboard style reporting of all active operations projects-Monitors projects from initiation through delivery-Helps drive requirements gathering, works on requirement planning and requirements management to ensure they meet demands of project's key stakeholders-Communicates with skateholders, obtains stakeholder engagement to ensure the end products or processes will solve the targeted needs Show less

Boulder, Colorado, United States

-Develop and implement risk-based and flexible approach to QA, which will ensure that trial participants and data generated are safeguarded in compliance with applicable regulatory requirements and best practice.-Develop, implement and maintain QMS and CAPA systems.-Interface with and act as a liaison to sponsors and study coordinators, and take the lead in presenting to any potential sponsor or funders in contractual negotiations.-Provide expert advice and guidance to the teams… Show more -Develop and implement risk-based and flexible approach to QA, which will ensure that trial participants and data generated are safeguarded in compliance with applicable regulatory requirements and best practice.-Develop, implement and maintain QMS and CAPA systems.-Interface with and act as a liaison to sponsors and study coordinators, and take the lead in presenting to any potential sponsor or funders in contractual negotiations.-Provide expert advice and guidance to the teams responsible for creating and managing TMFs, including undertaking regular audits of TMFs to ensure compliance with regulatory requirements.-Ensure proper completion of regulatory binders, including Protocols, Case Report Forms, Informed Consent Forms, Source Documentation, Training Logs, Delegation of Authority, Device Accountability, Financial Disclosures, CVs, and other trial master file documents.-Lead the preparation for audits from external parties and regulations (A2LA audit, FDA, ISO 9001, IS0 14155, ICH E6).-Assist in updating and drafting current and new SOPs to align with GCP practices.-IRB Submission documents, communications, and audits (Advarra CIRBI and Salus). Show less

Fort Collins, Colorado, United States

Project Management Experience• NPD/LCM, focus on development of analytical methods to support multiple projects at dif phases of maturity, clinical trials; facilitate method transfer to CROs or internal QC• Create and present weekly/monthly project status, data reports to various stakeholders• Develop project charters, roadmaps and milestones, led key stakeholder engagement and accountability• Negotiate agreements/contracts; Manage vendors/CROs and all studies and SOW… Show more Project Management Experience• NPD/LCM, focus on development of analytical methods to support multiple projects at dif phases of maturity, clinical trials; facilitate method transfer to CROs or internal QC• Create and present weekly/monthly project status, data reports to various stakeholders• Develop project charters, roadmaps and milestones, led key stakeholder engagement and accountability• Negotiate agreements/contracts; Manage vendors/CROs and all studies and SOW outsourced• Participate in team meetings to aid in development using technical expertise to facilitate AD of viable products to meet project goals• Define, monitor, and manage KPIs; project risk evaluation and mitigation; manage departmental spending to stay within the established budgetAnalytical Experience• Leadeership role for Analytical Development by prioritizing projects to meet timelines; oversee work schedules to ensure on-time delivery of results• Research for product development, including regulatory and API information• Design of experiments, forced degradation studies, robustness, validation/verification studies• Evaluate analytical data for validity; basic statistical analysis including ANOVA, t-test, regressionTechnical Writing and Regulatory Experience• Write, review, and approve technical reports, analyses, test methods against current guidelines and/or specs• Create CTD modules for FDA/global submissions, including ANDA, NDA, and IND• Generate and/or review specifications, COA; review stability report• Evaluate product ideas from data sources, such as SBOAs, patents, DMF, FDAs Orange Book, into justifications to pursue• Author/review plans/tables/figures/graphs for content, format, and consistencyQuality Experience• Conduct lab investigations (QEs, change controls, CAPAs, root cause, 5WHY analysis. Fishbone diagram)• Ensure operations are in FDA, GMP and/or GLP, CFR Part 11 compliance• Audit/inspection readiness; interact with marketing partners/regulatory agencies Show less

United States

• Provide a leadership role for analytical development; supervise the development of appropriate assays for testing and release of pharmaceutical drug products, raw materials, and stability samples, and facilitate successful method transfers to QC• Manage and create regulatory documents for FDA submissions; final approver for AD documents for ANDA filings, validation protocols/reports, investigations/DCAs, test methods, and company procedures• Evaluate analytical data for validity and… Show more • Provide a leadership role for analytical development; supervise the development of appropriate assays for testing and release of pharmaceutical drug products, raw materials, and stability samples, and facilitate successful method transfers to QC• Manage and create regulatory documents for FDA submissions; final approver for AD documents for ANDA filings, validation protocols/reports, investigations/DCAs, test methods, and company procedures• Evaluate analytical data for validity and ensure that all operations and functions (including the laboratory) are in full FDA, ICH, GMP and/or GLP compliance; and that staff is properly trained• Participate in audits (as needed) and directly interact with potential marketing partners, regulatory agencies, and contract labs• Prioritize projects to meet timelines and prepare/oversee work schedules to ensure on-time delivery of results Show less

• Independently, with little supervision, develop and validate analytical methods to current ICH, USP, and FDA guidelines• Perform routine sample analyses of formulation, drug, and product samples in support of GLP and R&D stability protocols• Write and review technical reports, summaries, protocols, test methods, and SOPs, in accordance to government regulations• Perform equipment troubleshooting, maintenance, and repairs• Serve as a resource for other analysts, and provide… Show more • Independently, with little supervision, develop and validate analytical methods to current ICH, USP, and FDA guidelines• Perform routine sample analyses of formulation, drug, and product samples in support of GLP and R&D stability protocols• Write and review technical reports, summaries, protocols, test methods, and SOPs, in accordance to government regulations• Perform equipment troubleshooting, maintenance, and repairs• Serve as a resource for other analysts, and provide guidance and training of routine testing and method development• Member of Lab Excellence Core Team whose primary focus is to maintain a safe, 5S friendly, lean laboratory environment• Evaluate active pharmaceutical product technical packages for source selection and product knowledge to assist in development• Exercise technical discretion in the design, execution, and interpretation of experiments that contribute to project strategies• Assist the QC laboratory in troubleshooting method issues Show less

• Performed finished product, in-process, bulk, stability, and raw material testing using in-house methods and USP testing• Member of the instrument team; conducted maintenance (including annuals and quarterlies), calibrations, and troubleshooting steps on various equipment, with a solid focus on HPLC• Member of safety and training team; trained coworkers on new methods, lab techniques, and HPLC qualifications• Completed method transfers and worked closely with analytical… Show more • Performed finished product, in-process, bulk, stability, and raw material testing using in-house methods and USP testing• Member of the instrument team; conducted maintenance (including annuals and quarterlies), calibrations, and troubleshooting steps on various equipment, with a solid focus on HPLC• Member of safety and training team; trained coworkers on new methods, lab techniques, and HPLC qualifications• Completed method transfers and worked closely with analytical development to troubleshoot, properly execute tests, and develop methods to meet the needs of the QC department• Facilitated lab investigations and generated data for validations and OOS/OOT studies Show less

• Familiarized with the basic needs and guidelines of a laboratory setting while reinforcing previous knowledge of pharmacology and physiology; recognized groups of drugs, their mechanisms, and clinically relevant side effects • Acquired basic lab techniques, prepared/analyzed lab samples; ran in-house blood work, cytology, and cultures• Maintained appropriate disposal protocols for hazardous materials; Sustained sanitation/nosocomial protocols for the facility• Created and… Show more • Familiarized with the basic needs and guidelines of a laboratory setting while reinforcing previous knowledge of pharmacology and physiology; recognized groups of drugs, their mechanisms, and clinically relevant side effects • Acquired basic lab techniques, prepared/analyzed lab samples; ran in-house blood work, cytology, and cultures• Maintained appropriate disposal protocols for hazardous materials; Sustained sanitation/nosocomial protocols for the facility• Created and maintained all appropriate facility and medical records and logs in compliance with federal regulatory guidelines (e.g. radiography, surgery, anesthesia, laboratory, controlled substances) Show less

Brookfield, Connecticut

Started and completed an education connection internship, which resulted in a permanent part-time position. Left on excellent terms to pursue an education at CSU with the offer of a full-time position upon return to CT. Remained an employee throughout college when returned for summer vacation.

New Fairfield, Connecticut

Summer job only