- Served as a technical Subject Matter Expert on supplier technical capabilities, control strategies, as well as manufacturing needs.- Supported development and implementation of raw material control strategies and monitoring technologies related to incoming raw material release to support manufacturing operations across Biogen's manufacturing network.- Worked to standardize single use systems across the RTP DS site, specifically aseptic connectors- Helped to manage and circumvent single use system shortages through use of alternative items on hand and temporary change memos through suppliers.- Supported end to end global extractables/leachables studies, participated in partnership E/L collaboration and industry forums on E/L, and responsible for ensuring Biogen E/L program is consistent and up to date with global regulatory guidance.- Raw materials continuous improvement and technical advancement opportunities, including Custom item request technical support of new supplier audits. - Provided investigation support for Biogen's global manfacturing networks including, laboratory experiments, gathering data from suppliers, developing historical trend data and collecting lot use information in the manufacturing process.- Took part in vendor site audits as technical support.- Authored and reviewed relevant sections of regulatory submission documents.

- Served as a technical Subject Matter Expert on supplier technical capabilities, control strategies, as well as manufacturing needs.- Supported development and implementation of raw material control strategies and monitoring technologies related to incoming raw material release to support manufacturing operations across Biogen's manufacturing network.- Supported end to end global extractables/leachables studies, participated in partnership E/L collaboration and industry forums on E/L, and responsible for ensuring Biogen E/L program is consistent and up to date with global regulatory guidance.- Raw materials continuous improvement and technical advancement opportunities, including Custom item request technical support of new supplier audits. - Provided investigation support for Biogen's global manfacturing networks including, laboratory experiments, gathering data from suppliers, developing historical trend data and collecting lot use information in the manufacturing process.- Authored and reviewed relevant sections of regulatory submission documents.

- Continued work in Upstream and Downstream manufacturing of both biologics and oligonucleotides for clinical applications in an environment that specializes in usage of disposable technology- Assist Manufacturing Associates in troubleshooting of equipment as necessary- Work on projects and efforts to continuously improve the factory as well as identify new technologies to enable continuous improvement- Run an engineering subteam committed to handling and improving single use technologies within the factory- Process Transfer of both upstream and downstream biologics and ASOs- Continue oversight of area HPLC technology, training personnel on the equipment and assays and helping troubleshoot as needed. Also assist in company effort to bring a Waters Patrol system into the area- Continue to help manage a Manufacturing Knowledge Community of Practice to provide all company employees a means to learn about the Manufacturing process

Upstream and Downstream manufacturing of biologics and oligonucleotides for clinical applications in an environment that specializes in usage of disposable technology. Performance and documentation of daily manufacturing operations in a GMP environment that involves operation of process equipment, creating/revising cGMP documents, initiation/investigation of deviations, as well as performance of numerous area projects. Gained knowledge of both Downstream operations and single use equipment by functioning as an area lead on both sides of the Manufacturing process and by helping train other associates on floor operations. Collaboration with other departments on projects related to area equipment and training, such as: disposable shake flasks, buffer hold expirations on Chromatography columns, harvest technology studies. Spearheaded a project to bring HPLC technology to the Manufacturing floor, setup system infrastructure, learn software required (Empower 3). Also trained operators on the equipment and performed assay qualifications/validations, as well as troubleshooting when needed. Presently leading downstream process transfer for clinical FVM biologic. Created and manage a Manufacturing Knowledge Community of Practice to provide all employees a means to learn about the Manufacturing process.

Upstream and Downstream manufacturing of proteins for clinical and preclinical applications in an environment that specializes in usage of disposable technology. Performance and documentation of daily manufacturing operations in a GMP environment that involves operation of process equipment, creating/revising cGMP documents, as well as performance of numerous area projects. Gained knowledge of both Downstream operations and single use equipment by functioning as an area lead on both sides of the Manufacturing process and by helping train other associates on floor operations. Collaboration with other departments on projects related to area equipment and training, such as: disposable shake flasks, buffer hold expirations on Chromatography columns, harvest technology studies, and introduction and operation of HPLC technology on the Manufacturing floor. Created and manage a Manufacturing Knowledge Community of Practice to provide all employees a means to learn about the Manufacturing process.

Upstream manufacturing of proteins for both commercial and clinical applications in a small scale setting. Performance and documentation of daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of commissioning and/or validation protocols, and creating/revising cGMP documents. Furthering knowledge both as a team lead and by helping train other associates on floor operations as well as becoming familiar with microfiltration and centrifugation systems and associated equipment. Collaboration with other departments on projects regarding automation and technical development operations.

Upstream manufacturing of proteins for both commercial and clinical applications in a small scale setting. Performance and documentation of daily manufacturing operations in a cGMP environment that involves operation of process equipment, execution of commissioning and/or validation protocols, and creating/revising cGMP documents. Gained a thorough understanding of media/buffer prep and support activities, aseptic technique in hood operations, and standardization/use of scales, meters, and cell counters.

• Handled insurance claim issues/rejections• Ordered drugs from the CVS warehouse and outside vendor, Cardinal Health• Arranged incoming pharmacy items/drugs• Assisted in store duties; running registers, answering calls, inputting and filling prescriptions, contacting doctors and patients whenever necessary