Stephen Preston Email & Phone Number

Lexington, Massachusetts, Us

Lund, Se

- Manage the following departments, managers, or supervisors in Fermentation, Blending, Maintenance and Sanitation.- Collaborate and communicate regularly with WA Production Scheduling, Quality, and Packaging leadership to ensure that orders are delivered Right First Time at the correct quality specification.- Work closely with and communicate regularly with peers, or executive management to identify areas for investment, provide action plans for areas of business, technical or personnel improvement- Responsible for developing and implementing techniques and technology to improve probiotic counts and shelf life- Responsible for managing the process of developing fermentation protocols and procedures for current, and future strains- Assess equipment needs, source and purchase equipment when appropriate or delegate.- Collaborate with engineers to bring new production equipment online, stabilize the process and take the time and effort necessary to develop robust manufacturing techniques to address counts, stability, and control COGs- Ensure that all production areas operated under proper cGMP guidelines- Ensure that the manufacturing facilities are run in accordance with State and Federal regulatory statutes- Maintain accurate and timely communications with administration functions- Generate, update, and approve SOPs as necessary to reflect current manufacturing.- Assist with facility audits. This should include FDA, third party, and client audits.- Provide motivation to all employees to add to the company culture in a positive and healthy manner and be a role model for good behavior.- Represent the company during business functions or audits as necessary

Lund, Se

• Responsible for managing a team consisting of Fermentation Engineers and Microbiologists. • Increased the overall yield in the Fermentation Department by an average of 35% from developing and implementing new techniques and technologies.• Improved overall stability of all probiotic strains by an average of 30% from developing eight new cryoprotectant formulas.• Performed the IQ/OQ/PQ of the new liquid pelletizer, wrote an SOP, and trained all operators on new procedures.• Responsible for developing fermentation protocols and procedures for current and new probiotic strains.• Collaborate with the Mechanical Engineering Team to bring new production equipment into the facility and to develop manufacturing techniques that address quality, yield and COG's targets.• Cross-trained in the role of Fermentation and Blending Manager and have acted in that capacity when needed. • Consistently monitor the production floor to ensure that processes and procedures are followed. • Prepare and implement formal training for department personnel on process improvements.• Prepare cost justifications for capital equipment purchases and outside services.• Represent department in GMP audits.

Bothell, Wa, Us

• Oversaw the activities of all manufacturing personnel to ensure production according to cGMPs and SOPs and the effective use of materials, equipment and personnel to produce quality products. • Recruited, trained, qualified and developed 11 team members to support key performance goals.• Ensured all processes and the environment were designed to maintain aseptic conditions. Reduced environmental monitoring excursions from 3% to less than 0.5% per month.• Continually improved the manufacturing program to prevent defects, minimize variability, and to maximize capacity. Increased yield from 88% to 90.3%, equivalent to $170,000 additional profit per quarter.• Created a capacity plan and identified constraints to ensure production volume was maintained in accordance to customer demand, and proposed process improvements based upon identified constraints.• Wrote and edited SOPs for the operation and maintenance of production equipment. • Maintained records and the clean room environment to comply with regulatory requirements, cGMPs, and SOPs. • Wrote, reviewed, and executed validation protocols.• Performed investigations and root cause analysis into production related quality system events (deviations, non-conformances, audit findings, trends, etc.).• Authored and reviewed departmental procedures to ensure compliance with ISO 13485 and other standards identified by the business.• Led tours and represented department during internal, external, and third-party audits.• Helped oversee the manufacturing budget and review of expenses. • Served as Safety Manager.

• • Continuous improvement in yield due to manipulations in media recipes, monitoring of centrifuge operation, and more consistent training equating to 100% increase in output.• Located, inspected, and acquisitioned second set of freeze driers resulting in doubling the manufacturing output.• Managed an entire facility remodel to accommodate new driers including installation, permits, P&ID’s, writing SOP’s, automation, and training of all personnel.• Represented department in three-day FDA audit.• Purchased supplies and equipment to meet the needs of the Fermentation Department.• Responsible for managing, preparing, and implementing training for 13 direct reports.• Provided support to my department supervisors regarding concerns related to team members.• Scheduled fermentation based on sales requirements, inventory reviews, and processing needs.• Prepared cost justifications for capital equipment purchases and outside services.• Oversaw the preparation and implementation of SOP’s for the department.• Ensured departmental compliance with established GMP, safety, and quality standards.• Conducted fermentation and process optimization.• Served as Safety Manager.

Bothell, Wa, Us

• • Involved in FAT, SAT, IQ, OQ, PQ for new 750L and 3000L bioreactor train.• Wrote SOP for the bioreactor train and trained operators on new procedures.• Participated in an entire facility remodel to accommodate the bioreactor train and was responsible for bioreactor start-up and harvest procedures. • Identified and implemented efficient set up of harvest train equating to two hours less processing time.• Implemented new I-test procedure for air filters and concentration skid saving 10 minutes per test.• Consolidated nine SOP’s into a single SOP for better document control.• Participated in conformance runs and preparing the facility for PAI.• Responsible for supervision of staff including production schedule and assigning PM’s.• Ensured compliance with procedures (SOPs and MBRs). • Reviewed documentation daily for appropriate completion.• Identified and ensured initiation and closure of deviations that occurred during each shift.• Completed timely reviews of media and solution MBRs and logbooks.• Communicated any deviations from the production schedule to the next shift.• Ensured all daily activities were scheduled and completed for the shift.• Participated on the Emergency Response Team.

Thousand Oaks, Ca, Us

Involved in the manufacturing of clinical and developmental material under cGMP regulations.• Managed project that changed single use pH probes to multiuse pH probes. Project reduced operating costs by $37 thousand per year.• Supervised project that purchased, installed, validated and wrote procedures to implement a wave bioreactor allowing maintenance of cultures in smaller shake flasks.• Revamped air filter use policy to allow multiple uses for the same molecule which saved the department $18 thousand per year.• Completed installation of new automated system for bioreactors which allowed for improved systems control. • Proven expertise troubleshooting bioreactor complications enabling a success rate of 90% per year. • Executed the cleaning, pressure testing, and steaming of process equipment; this included assembling small and large scale bioreactors, a media filtration cart, the MF system, the UF system and depth filters. • Maintained cell lines through the process of vial thaw, spinner maintenance, bioreactor inoculation, sampling and maintenance.• Utilized harvest techniques (depth filtration, MF technology, UF technology, TFF filtration and centrifugation). Produced 100% success rate for these steps.• Eliminated need for the Validation Department by performing product changeover (TOC testing, documentation revision) and validation protocols.• In charge of documentation: nonconformance owner, change control owner, authored and revised SOPs, and reviewed completed batch records.• Coached new associates on process theories and applications to standardize procedures between shifts. • Earned top ranking among peers in 2002, 2003, and 2004/recognized in top 5% of peer group in 2006.• Served as an Emergency Response Team member and participated in full-site emergency exercises.

Thousand Oaks, Ca, Us

Strengthened skill set and aligned best practices during six-month cross training. • Served as team lead for the AMG 655 campaign; accountable for production planning and scientist collaboration.• Completed column packs which utilized the flow-through technique and IsoPak skid. Successful packs ensured symmetrical flow and appropriate height equivalent to a theoretical plate (HETP) allowing for optimal protein binding and recovery.• Executed affinity chromatography, ion exchange, cation exchange, viral inactivation and viral filtration which expanded my comprehension of cell culture.

Thousand Oaks, Ca, Us

Supported the start-up and technical transfer activities within the media preparation, buffer preparation and cell culture areas.• Simulated system variables to test automation software accuracy and robustness.• Verified SIP cycles to confirm valve positions, steam paths and post SIP isolation.• Undertook general process troubleshooting to ensure the timeline for submission to the FDA was maintained. • Supervised transfer of technology from the Bothell clinical facility to the Rhode Island bulk manufacturing facility. Successful transfer enabled the company to maintain an adequate supply for the patients. • Created and reviewed SOP's to establish best practice.

Emeryville, California, Us

Preparation and monitoring of mammalian cell culture.• Maintained the cell line which included spinner preparation, preparation of buffers and media, bioreactor preparation and monitoring, and harvest techniques.• Assisted in validation studies.

Emeryville, California, Us

Preparation and monitoring of 1500L microbial fermentation.• Sustained E. coli cell line. Duties included purifying the protein which included harvest, concentration/diafiltration (TFF), homogenization, centrifugation and organic extraction.• Prepared and monitored 14L fermentor which was used for working stock.• Performed tasks in a cGMP bulk manufacturing environment.