LEANNE AGOSTINO
Medford,MA
Summary
Dynamic manufacturing leader with a proven track record at Fagron Sterile Services, driving production capacity by 100% through efficiency optimization and continuous improvement initiatives. Expertise in SOP writing and team direction, coupled with a strong commitment to compliance and quality, ensures operational excellence in sterile filling and aseptic procedures.
Overview
25
25
years of professional experience
Work History
Director, Manufacturing Operations
Fagron Sterile Services
Canton, MA
02.2022 - Current
- Overall management and coordination of all production personnel, support personnel and processes in a split shift operation, with additional shifts in process
- Direct and coordinate four individual departments: Component preparation, drug compounding, aseptic filling, capping, visual inspection, labeling, secondary packaging, label printing and review, documentation coordination and technical writing for multiple production lines.
- Collaborate with QA, QC, R&D and validation to implement new processes, add new equipment, add new products and investigate deviations to drive product release.
- Obtained DEA license and implemented controlled substance manufacturing
- Doubled production capacity in one year by increasing batch size 2-3x, increasing batch yield via continuous improvements and expanding production hours
Senior Manager, Production
Fresenius Kabi Compounding
Canton, MA
09.2019 - 02.2022
- Manage and coordinate activities and performance of assigned staff to ensure the achievement of department operational excellence objectives, cGMP’s, safety standards and performance goals.
- Plans, defends and presents related budgetary and production performance metrics/activities.
- Reviews/ensures investigations, deviations and new and existing validations are completed.
- Works in a team environment with other site management to coordinate a production schedule to achieve required deadlines, customer demands, new product launch, objectives and budgets.
- Establishes and administers operational procedures and batch records for equipment maintenance, vapor hydrogen peroxide (VHP) disinfection, aseptic filling(ISO 5 hood, in an ISO 7 room), visual inspection, and product labeling and packaging activities.
- Interacts with regulatory agencies and customers during audits.
- Increased staffing levels, production capacity and scaled up production batch size based on customer demand and profitability.
- Implementing RFID tag labeled products and obtaining a DEA license to produce controlled substances.
Production Manager
Ocular Therapeutix
Bedford, MA
09.2018 - 09.2019
- Lead daily production meeting with team to establish daily goals and address any production issues.
- Manage all daily production requirements for commercial manufacturing including equipment trouble shooting and maintenance: lyophilizers, heat sealers, pipettes, scales, glove box, ovens and label printers.
- Establish plans and deliver on the established Production Operation’s annual goals and objectives.
- Define necessary corrective and preventative action in response to internal, regulatory, and customer audit requirements as well as deviation investigation.
- Instill a culture of continuous process improvement with a quality focus. Pursue industry 'best practices' associated with clinical and commercial production operations. Operational excellence team member.
- Assist in managing late phase clinical and new product launch, including labeling and packaging.
- Review Master Batch Records, SOPs, Qualification/Validation protocols and reports, and other essential cGMP documents.
- Write and revise Standard Operating Procedures and other operational documents as needed.
- Work with counterparts in Quality Assurance and Quality Control to release material in a timely fashion.
- Provide appropriate coaching, development, and associated performance management for the production operations staff. Ensuring all regulations are being adhered to for controlled packaging areas and ISO 7 and 8 Cleanrooms. Including tracking of training requirements in MasterControl.
- Quality council team member
- Assisted in implementation of QAD, an electronic inventory management system, including establishing routings and BOMS
- Implemented laundered cleanroom gowning system to decrease cost and bioburden risk
Manufacturing Manager
Vascular Technology
Nashua, NH
04.2016 - 09.2018
- Execute on-boarding, cross-training, discipline and personal development strategies for 25 direct reports.
- Ensured manufacturing equipment was in working order and safety guidelines were being adhered to including: Microscopes, UV adhesive, UV lights, heat sealers, soldering irons and labeling systems.
- Collaborated with temp agencies to increase staffing levels by 25%.
- Researched and assisted in implementing GTIN barcode labeling system per FDA requirements.
- Mastered the intricacies of the process flow within the manufacturing and quality departments to increase production by 85% without sacrificing quality.
- Physical and electronic Inventory management of raw materials and finished product, including POs, routings and BOM maintenance to ensure customer needs were satisfied for sterile single use doppler probes and transceivers.
- Ensure full time and temporary employees are trained appropriately and are adhering to all safety and regulatory requirements in controlled manufacturing areas and ISO 8 Clean room.
- Member of the safety committee.
- Implemented laundered cleanroom gowning system to decrease cost and bioburden risk.
- Developed and maintained strong and clear communication and rapport with manufacturing and quality personnel.
Manufacturing / Production Consumables Supervisor
Rapid Micro Biosystems
Lowell, MA
01.2015 - 04.2016
- Developed and implemented a cross training program, allowing for more efficient staffing levels. Including recurring training, documentation and records retention.
- Process development, SOP updating to ensure documentation accurately reflects current processes. Transitioning R&D processes to manufacturing.
- Establish and adhere to production schedule to meet customer needs.
- Communicate with quality, customer service and upper management on production run yields, product quality, inventory and potential customer impact.
- Perform and enforce aseptic technique and SOP adherence in ISO 6 and ISO 8 cleanrooms.
- Ensure all manufacturing equipment is in safe working order and within calibration, troubleshooting and corrective action implementation when needed.
- Member of the safety committee.
- Review batch record paperwork for accuracy and completeness, release product to inventory.
- Identified staffing and capital needs, collected relevant data and developed budget.
- Assisted in the development of a robotically operated manufacturing line, including design review and travel to offsite build location.
Manufacturing/Production Supervisor
Conformis
Burlington, MA
02.2013 - 01.2015
- Led regular stand-up meetings, events and continuous improvement projects with measurable goals.
- Adhere to and enforce compliance to ISO and FDA requirements, including timely cleaning and maintenance of all equipment.
- Initiate and investigate NCMRs as required for non-conformances, address root cause and implement corrective actions and training.
- Plan, schedule and coordinate production activities to meet inventory and customer requirements. Including inventory and raw material control via Oracle.
- Allocate resources to fabricate, inspect, assemble, 3D print, CIP, pouch, sterilize, label and box sterile single use and implantable products in controlled manufacturing areas and ISO 8 cleanroom.
- Participate in Lean/5S initiatives including Kaizan events and value stream mapping.
Manufacturing Supervisor
American Red Cross
Dedham, MA
01.2009 - 02.2013
- Interview, hire, terminate, evaluate, train and manage large staff in a union environment.
- Review/audit all paperwork for accuracy prior to release of blood product.
- Ability to operate all equipment/performed all operations throughout manufacturing process.
- Optimized scheduling of 45 technicians based on deep expertise of production capacities and equipment. Allowing for 24/7 coverage of production activities while decreasing overtime costs.
- Worked closely with QA, QC and customer service depts. to ensure compliance and customer needs were achieved while adhering to internal SOP's, GMP and FDA regulations.
- Acted as a SME and point of contact for FDA and internal audits.
Manufacturing Technician
American Red Cross
Dedham, MA
01.2007 - 01.2009
- Completed manufacturing tasks as assigned including: ABO labeling of blood products (Whole blood, red cells, platelets and frozen plasma), sampling and dividing platelets into appropriate storage containers based on yields, washing red cells, freezing red cells, irradiating and quarantining blood components.
- Concurrently and accurately completing paperwork.
Hematology Lab Assistant
Beth Israel Medical Center
Boston, MA
01.2001 - 01.2007
- Collected, organized and analyzed clinical data for problem management, regulatory and inspection purposes.
- Communicated information regarding ongoing studies to anticipate problems and increase efficiency.
- Calibrated, performed maintenance and reviewed logs for all lab equipment including: pipettes, clocks, stopwatches, water baths, refrigerators, freezers and centrifuges.
- Prepared reagents and stains for various blood smears, including bone marrow, proficient in all general lab techniques.
Education
M.B.A. -
UMASS Lowell
Lowell, MABachelor of Science - Health Science
Massachusetts College of Pharmacy
Boston, MAMaster of Science - Biopharmaceutical Regulatory Affairs
Northeastern University
Boston, MASkills
- Team direction
- Production scheduling
- Budget management
- SOP and batch record writing
- Change control processes
- Inventory oversight
- MRP and ERP systems
- Manufacturing expertise
- ISO compliance
- Cleanroom protocols
- Sterile filling techniques
- Aseptic procedures
- Visual inspection skills
- Labeling and packaging
- Controlled substance regulations
- DEA compliance knowledge
- Deviation analysis
- Root cause identification
- CAPA implementation
- Training program design
- Training delivery
- Continuous improvement initiatives
- RFT enhancement strategies
- Efficiency optimization
Timeline
Director, Manufacturing Operations
Fagron Sterile Services
02.2022 - Current
Senior Manager, Production
Fresenius Kabi Compounding
09.2019 - 02.2022
Production Manager
Ocular Therapeutix
09.2018 - 09.2019
Manufacturing Manager
Vascular Technology
04.2016 - 09.2018
Manufacturing / Production Consumables Supervisor
Rapid Micro Biosystems
01.2015 - 04.2016
Manufacturing/Production Supervisor
Conformis
02.2013 - 01.2015
Manufacturing Supervisor
American Red Cross
01.2009 - 02.2013
Manufacturing Technician
American Red Cross
01.2007 - 01.2009
Hematology Lab Assistant
Beth Israel Medical Center
01.2001 - 01.2007
M.B.A. -
UMASS Lowell
Bachelor of Science - Health Science
Massachusetts College of Pharmacy
Master of Science - Biopharmaceutical Regulatory Affairs
Northeastern University
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