Ethan Swifka Email & Phone Number

Hampton, England, United Kingdom

Central Region

Libertyville, Illinois, United States

Owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups.Ensures manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site.Supports the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support).Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites. Serves as a manufacturing document owner for certain production process steps.Owns critical manufacturing deviation investigations and define pragmatic and effective CAPAs.Identifies, develops and implements process robustness improvements through lean principals.Leads process specific training for the direct manufacturing group.Supports internal and external audits for manufacturing process steps.Supports the PMO group for any technology transfer activities.Owns manufacturing process related change controls.Maintains quality standards to meet GMP requirements, CFR’s and internal company policies with respect to the manufacturing process.Provides manufacturing SME support on capital related projects.Other related duties as assigned.

Illinois

Produce clinical and commercial material on an annual basis that meets the site’s strategic objectives and is compliant with cGMPs. Works on the manufacturing floor to produce product, troubleshoot equipment, and provide ownership for specific pieces of processing equipment.Ensure cGMP documentation is being filled out correctly, training is current and all Quality requirements are being followed. Participate in tours or information requests for all FDA and internal audits of the manufacturing facilities/processes and respond to any observations received per procedure. Responsible for maintaining quality standards to meet cGMP requirements, CFR’s, and internal company policies related to the manufacturing process. Support tech transfer of new products and processes to ensure smooth transition from process development into GMP manufacturing. Provide hands on technical leadership to the manufacturing staff members. Look for opportunities to implement operational excellence and continuous improvement. Partner with Quality to ensure a quality and compliant manufacturing environment. Support Director of Operations to meet information requirements as needed for quality, compliance, and management reporting. Assist the technical operations team to resolve any issues related to production. Other related duties as assigned

Thousand Oaks, Ca

Primary manufacturing SME for validation of MES within Cell Bank (100% EBR Q1 2017). Drive continuous improvements to Cell Bank EBRs. Currently in early stages of EQM implementation. Perform cell banking operations according to cGMP, includes - aseptic operations for cell culture scale-up and freeze of mammalian cell banks, perform shakedown runs and analyze data related to cell bank performance under minimal supervision. Participate in cross-functional teams, representing the cell banking group. Design and perform different scientific experiments related to the cell bank process, document results in EBR, communicate findings in written technical reports. Perform and monitor critical processes, draft, review and approve documents such as MPs and technical reports. Assist in preventative maintenance work orders and support the Cell Bank's system owner.

Amgen - Thousand Oaks, Ca

Member of the Cell Culture Expansion group at Amgen, responsible for all production operations. Perform aseptic cell culture scale-up/vial thaw. Hands-on operation, set-up, cleaning, and sanitization of bioreactors and various cell culture supports vessels. Prepare buffers/media per defined MP/EBR and SOPs. Follow GMP documents with strict adherence to safety and compliance. Monitor critical processes, perform in process sampling of cell culture equipment and operate analytical equipment. Washroom activities; clean equipment, small to large scale, used in production activities. Assist in the training of new-hires.

Greater Seattle Area

Part of a 12 person production team at NanoString Technologies requiring exceptional communication and independent time management skills. Manufactured intermediates and finished goods used in Consumables production. Performed QCs on incoming material and finished products before release. Knowledge of ISO and FDA auditing procedures. Familiar with manufacturing QSPs and SOPs, including development. Assisted in the training of new-hires on all Consumables group tasks. Proficient in Microsoft Dynamics NAV, MasterControl, Microsoft Excel/Word/Outlook.

Tacoma, Wa

Over 400 hours clinical experience as a medical scribe in 3 Emergency Departments. Maintained patient medical charts created during time of visit/examination by Physician.

Greater Seattle Area

Selected to assist in the management of the Student Resource Center during the academic year. Trained all new staff on customer service and duties expected. Ensured printers and equipment were fully stocked, and in proper condition. Handled customer service issues that surfaced in a quality, caring way. Assisted in development and repair of technical software/programs used.

Greater Seattle Area

Utilized aggressive, personal strategies to establish a client base in the Ballard/Greenlake area. Devised solutions and negotiated resolutions to ensure client satisfaction. Interfaced with materials suppliers and concurrently lead two production teams. Integral manager for the fastest growing division in the company. Successfully completed 20 projects in a three month period. Produced projects at a total of a 20.0% profit margin. Placed in top 10 of sales in state of Washington.

Masters Of Public Health

Bachelor Of Science (B.S.), Cell/Molecular & Developmental Biology