Jonathan Pickell Email & Phone Number

Glen Rock, Pennsylvania, United States

Marietta, Pa

- Oversaw manufacturing operations in vaccine formulation, aseptic filling, and lyophilization in support of MMR, Varicella, and Covid vaccine production in a class A environment.- Performed hiring, onboarding, training, and coaching of team members to build a strong, diverse, and competent team.- Performed compliance and safety audits and developed appropriate CAPA actions based on risk prioritization. Deviation owner.- Member of continuous improvement team responsible for following DMAIC process to implement improvement initiatives.

Framingham, Ma

Drove continuous improvement of department through metric based data collection, with established actions to drive improved performance.Coached supervisors in support of producing biologics products including Fabrazyme and Thyrogen, with a focus on building a competent and diverse team.Ensured that department delivered on required buffer, media and equipment preparation deliverables in support of Thyrogen production.Screened, interviewed, and hired new employees. Coordinated calibration and review activities as part of the performance management cycle for supervisors and staff.Reviewed production batch records, validation protocols, etc. to ensure that all SISPQ and GMP requirements had been met prior to product release.Performed audit tours and interacted with auditors to address questions

Supervised staff in daily operations including equipment PM, CIPs, SIPs, process operations and daily sampling in support of the production of Fabrazyme using CHO cell line. Performed and supervised operations in equipment prep, small scale, media and large scale cell culture areas.Highly competent in manufacturing review of production batch records and equipment use records. Worked closely with QA to ensure that any compliance issues were resolved in a cGMP compliant manner.Preformed validation operations on numerous classes of production equipment including glasswashers, autoclaves, small scale spinners, and media and large scale cell culture production vessels. Successfully maintained a challenging commissioning and process validation schedule to ensure that required timelines were met in a safe and compliant manner. Worked closely with safety department to ensure that all safety issues were elevated and resolved in a timely manner.Developed numerous SOPs, On-The-Job Training documents and electronic batch records during the startup of the cell culture facility. Developed aseptic technique procedures for the LFH which led to 100% success of the spinner train startup and validation.Trained and coached small scale and large scale staff on all production procedures including aseptic technique, spinner manipulations, process sampling, and large scale process operations.Expertise in multiple validated electronic systems including DeltaV, Werum MES, iLIMS, Trackwise and Plateau.Focus on staff development through training, goal development and one-on-one meetings to build a strong and diverse team. Assigned and developed staff trainers and participated in the training and sign off of staff OJTs which resulted in a fully trained and highly competent cell culture group.Conducted interviews and onboarding for new hires as a hiring manager. Worked with HR and contract recruiter to successfully screen and recruit job candidates.

Supervised and directed the daily shift operations of manufacturing associates on the production floor. Responsible for maintaining the scheduling and accuracy of upstream operations of Suite 5 fermentation processes.Interacted with Engineering, Automation and Technical Sciences departments to troubleshoot equipment and process related issues. Responsible for detecting and identifying equipment issues and initiating corrective actions.Developed and revised standard operating procedures for manufacturing operations including CIP, SIP and operation of fermentation equipment. Equipment included 280L and 2800L fermentors, process tanks, and large scale continuous flow centrifuges.Worked closely with contract commissioning team to aid in SAT, PQ and CIP/SIP cycle development of newly commissioned fermentation equipment. Supported tech transfer between multi-site fermentation manufacturing processes. Assisted with the development of solution preparation documents, production batch records, and bill of materials for implementation of new fermentation process.Experience working with several electronic systems including LIMS, Trackwise, SAP, Documentum, and DeltaV control system.Interacted with contract manufacturing clients on the production floor to ensure that customer expectations were being met and concerns were addressed in real time.

Cell Culture, Production/Harvest Amgen; Directed the scheduling and implementation of on-the-floor operations by production associates on shift to ensure that all cell culture production tasks were successfully accomplished.Trained new personnel on GMP operations including operation of 8k L production bioreactors, 20k L harvest tanks, Microfiltration and Ultrafiltration TFF skids.Performed review of manufacturing procedures, automated batch reports, and in-process control parameters to ensure that all specifications were within process control parameters.Documented non-conformances in a quality management tracking system. Assisted in non-conformance investigations and worked with manager, quality assurance and equipment owners to close NC tracking records in a timely and compliant manner as an NC Owner.Revised and improved SOP's and manufacturing procedures to ensure that instructions were clearly delineated and complied with GMP guidelines.Experienced in all operations of production/harvest equipment including operation of large scale MF TFF Skid and UF/DF TFF skid used in the harvest and concentration of the therapeutic protein Enbrel.Interacted cross-functionally with support departments including maintenance, instrumentation, and engineering to ensure that all corrective maintenance and scheduled maintenance was performed properly with no impact to the production schedule or health and safety.Implemented derouging procedures on a wide variety of equipment in buffer, media, cell culture and purification areas. Communicated with contract personnel and engineering department to ensure efficient and safe derouging activities during building wide production shutdown.Participated in Amgen's Emergency Response Team as a Sweeper and received first aid and CPR certification.

Performed aseptic subculture manipulations in a class II biosaftey cabinet and LFH including mammalian cell line thaws and spinner flask subculture of production CHO cell line.Experienced in CIP, setup, SIP and operation of 200 L and 1250 L bioreactors used to culture seed inoculum for 4k L perfusion bioreactors.Performed environmental sampling procedures including surface viability, air viability and particulate air sampling during aseptic subculture manipulations.Analyzed in-process cell culture samples for CHO cell viability, pH and other components to ensure that all parameters were within specifications.Drafted training qualification documents which are used as a training tool for Subject Matter Experts during the training and qualification of personnel on GMP operations.Participated in workplace safety organization ARCHES by conducting EHS inspections of the production floor and helped maintain a safe workplace environment through generating job hazard assessments for production operations.