GERMAN BALLESTEROS
Pompano Beach,USA
Summary
I am a highly motivated professional with twenty-four years of experience in the bio-pharmaceutical industry. My career began as a production operator, during which I gained comprehensive experience in all areas of manufacturing and advanced through roles of increasing responsibility, including supervisor and manager. I have consistently demonstrated strong organizational, communication, interpersonal, and problem-solving skills. I am seeking an opportunity to contribute to a high-standard, quality-driven environment while continuing to grow professionally. I am fluent in both English and Spanish. Efficient Manufacturing Manager with many years of experience in product manufacturing. Committed to thorough leadership and implementing modern systems of organization. Proficient in long-term budget management and acting as liaison between various departments.
Overview
25
25
years of professional experience
Work History
Production and Packaging Manager
Aveva Drug Delivery Systems
Tamarac, USA
07.2015 - Current
- Direct day-to-day site operations by setting priorities, managing activities, and ensuring the reliable production and delivery of high-quality products to Aveva’s customers in alignment with company goals.
- Align site operational strategy with broader business objectives, including demand forecasting, capacity planning, and successful execution of new product introductions.
- Lead, mentor, and develop a high-performing technical operations team, fostering a culture of ownership, accountability, collaboration, and continuous improvement.
- Cultivate a high-trust, results-driven work environment in which individuals and teams take clear ownership of outcomes; oversee establishment and maintenance of sterile manufacturing environments (ISO 7 & ISO 8).
- Oversee end-to-end production of sterile injectable products across multiple delivery formats, including Blow-Fill-Seal (BFS), vials, syringes, and cartridges.
- Optimize core manufacturing processes—compounding, aseptic filling, and packaging—to increase efficiency, reduce cycle times, improve yields, and minimize waste.
- Ensure project timelines, deliverables, and performance standards are clearly defined and consistently achieved.
- Define, track, and manage critical operational KPIs, including batch yield and scrap rates, throughput and cycle times, first-pass quality and deviation metrics, machine downtime and OEE, and on-time delivery and supply plan adherence.
GPO Manager
Abba Worldwide Solutions, Inc.
Houston, USA
08.2024 - 06.2025
- Established office in Houston to cover and support Central and West region.
- Determined annual unit and gross-profit plans by implementing marketing strategies and analyzing trends.
- Set sales objectives by forecasting and developing annual sales quotas for regions and projecting expected sales volume and profit for existing and new products.
- Implemented national sales program by developing field sales action plans.
- Maintained sales volume, product mix, and selling price by keeping current with supply and demand, changing trends, economic indicators, and competitors.
- Established and adjusted sale prices by monitoring costs, competition, and supply and demand.
- Managed national sales staff results by counseling and evaluating employees, planning, and monitoring.
- Consulting (Pharmaceutical, Bio-Medical, Vitamins – Process Improvement in Production)
Manufacturing Supervisor
Lonza Biologics
Houston, USA
11.2021 - 07.2024
- Managed team adherence to safety and cGMP regulations.
- Responsible for the execution of USP/DSP activities in the clean room.
- Plan daily activities in the clean room and provide the first line of problem-solving in case of any event.
- Ensure critical supplies are in stock and available for production.
- Responsible and accountable for the Kanban system.
- Train, coach, and mentor team in aseptic aspects of the department.
- Open & close deviations, CAPAs, work with the Investigation Team, QA, MSAT, and FE.
- Contributor or leader on MFG and OE projects to optimize and streamline processes.
- Responsible for interacting with other departments concerning the operations in Grade A/B/C/D environment.
- Complete and review batch records and production documents.
- Review and approve batch records, change controls, SOPs, and other documentation required for production operations.
- Member of audit teams: FDA, EMA and OSHA preparedness.
- Perform process and equipment validation (IQ/OQ/PQ).
- Conduct interviews for Core Technicians and supervisors.
- Employees reviews (Semestral), one-on-one (Biweekly), Disciplinary actions.
- Adhere to ALCOAC++ and CGDocP requirements while accurately performing procedures.
- Monitor the Aseptic Procedure System activities after each shut down.
- Achievements: Color-coded system for vent and expiry FIT (Filter Integrate Testing) process, Waste segregation System (EHS, EDS, ABM), Reduced DRs for the manufacturing department, Developed leadership (Core Techs), Coordinated and synchronized activities with ABM (Cleaning Team), Developed and supported shift change Notes, Created and developed cross-training system for the manufacturing department, Improved GDP, Batch records review improvement, RFT improvement, 6s for Portable Equipment, Materials & Gowning supplies, Improved cold material transfer system from Warehouse to Manufacturing, Increase lots produced, Cleaning change over activities improved, Reports and data analysis generated for production meetings.
GPO Manager
Abba Worldwide Solutions, Inc.
Houston, USA
10.2015 - 10.2021
- Established office in Houston to cover and support Central and West region.
- Determined annual unit and gross-profit plans by implementing marketing strategies and analyzing trends.
- Set sales objectives by forecasting and developing annual sales quotas for regions and projecting expected sales volume and profit for existing and new products.
- Implemented national sales program by developing field sales action plans.
- Maintained sales volume, product mix, and selling price by keeping current with supply and demand, changing trends, economic indicators, and competitors.
- Established and adjusted sale prices by monitoring costs, competition, and supply and demand.
- Managed national sales staff results by counseling and evaluating employees, planning, and monitoring.
- Consulting (Pharmaceutical, Bio-Medical, Vitamins – Process Improvement in Production), Optimize warehouse, Negotiation with suppliers, Transportation lead time, Season special stock.
Manufacturing Manager
Florida Supplement
Miramar, USA
06.2014 - 05.2015
- Developed and executed the monthly/yearly manufacturing plan for production volume, cost and quality to reach the business objectives.
- Participated with the manufacturing facility construction (Supplements & Vitamins) and equipment installation.
- Established and maintained a standard of performance for the operation team.
- Ensured the manufacturing principles were aligned with the company’s vision and priorities.
- Continuously developed and implemented optimizations which resulted in faster processing time.
- Ensured health & safety procedures policies were followed and company guidelines were implemented.
- Coordinated with the Engineering team to set up and implement operating procedures for production.
- Ensured deadlines were followed, and products were produced on time and were of good quality.
- Conducted performance appraisal for direct reports and ensured improvement with the overall quality of product.
- Estimated costs and maintained expense budget for production.
- Assessed manufacturing operations, specifically staffing, and skills. Developed a plan to address department needs following the assessment.
- Established manufacturing priorities and allocated the resources to achieve them.
- Developed and executed LEAN, 5s, and Six Sigma projects.
- Knowledge and implementation of maintenance requirements to ensure all equipment remains operational and safe for use.
Manufacturing Supervisor Dry Dosage
Watson Laboratories
Davie, USA
01.2009 - 01.2013
- Oversaw Granulation, Milling, Blending, Compression, Laser and Encapsulation processes.
- Prepared the training and qualification curriculum for production departments.
- Product transfer from other facilities.
- Created and prioritized daily workload and set timelines to meet required deadlines.
- Collaborated with the operational manager in R&D, cleaning validation, and production projects (Manufacturing processes and procedures).
- Supervised, coordinated and assured the procedures for all manufacturing equipment are performed in compliance with the SOPs and cGMP’s.
- Prepared, routed for approval, and submitted change control documents, CAPAs and investigations.
- Involved in the daily work assignments to provide consistent material flow throughout manufacturing.
- Participated in the manufacturing renovation facility (Oral Contraceptives), buying equipment, equipment installation and cleaning validation process.
- Writing and implemented standard operational procedures for manufacturing department.
- Implemented goals and objectives to increase productivity.
- Conducted employee evaluations and promotions twice a year.
- Reviewed executed batch records for errors.
- Oversaw granulation, milling, blending, compression, coating, and packaging processes for oral contraceptives and potent compounds.
- Ensured purity and quality of the product by monitoring manufacturing.
- Reviewed procedures striving to improve efficiency, enhance safety, and ensure compliance.
- Conducted monthly safety and housekeeping audits to ensure GMP compliance.
Unit Coordinator/Supervisor (Cleaning Science Department)
Watson Laboratories
Davie, USA
01.2006 - 01.2009
Unit Coordinator II / Mfg Supervisor (Acting) – Oral Contraceptives
Watson Laboratories
Davie, USA
01.2004 - 01.2006
Unit Coordinator
Watson Laboratories
Davie, USA
01.2002 - 01.2004
Manufacturing Operator
Watson Laboratories
Davie, USA
01.2001 - 01.2002
Education
International Management -
Externado University
Bogota, Colombia11.1997
Business Administration -
Agraria University
Bogota, Colombia01.1996
Skills
- Continues improvement
- One Time Delivery
- Excel (Pivot Tables and Slicers)
- SAP
- Smartsheets
- MODA ES
- JDE
- Trackwise
- Qmas
- ISO Train
- MACOLA
- Power BI
- Cost Reduction
- Planning Scheduling and Strategies
- Able to take on ancillary cross-functional projects and drive to completion
- OSHA
- Material Safety Data Sheets
- Product Process Validation
- New Equipment Validations (IQ, PQ, OQ, etc)
- Cleaning Validation and Verification
- Lean Manufacturing
- 6s
- Six Sigma
- Qualification in Tablet presses (Kikusui, Killian, Fette)
- Glatt
- Pan Coating
- Blending and Packaging
- Fitzpatrick Milling Machine
- Tray Dry Ovens
- Train the Trainer
- Able to establish new systems or processes to achieve manufacturing goals and reduce workplace error
- Pharmaceuticals Manufacturing Management
- Incident Investigation
- Operations and Materials Management
- CAPA workshop
- The Most Effective Supervisor
- Personal Protective Equipment
- RFT New Culture
- Process Manufacturing and Validation
Training
- Pharmaceuticals Manufacturing Management
- Incident Investigation
- Operations and Materials Management
- CAPA workshop
- The Most Effective Supervisor
- Personal Protective Equipment
- RFT New Culture
- Process Manufacturing and Validation
- Certified Forklift Operator
- Current Good Manufacturing Practices (cGMP)
- SOP Compliance Training & Safety Awareness 21 CFR Part 210 & 211
Timeline
GPO Manager
Abba Worldwide Solutions, Inc.
08.2024 - 06.2025
Manufacturing Supervisor
Lonza Biologics
11.2021 - 07.2024
GPO Manager
Abba Worldwide Solutions, Inc.
10.2015 - 10.2021
Production and Packaging Manager
Aveva Drug Delivery Systems
07.2015 - Current
Manufacturing Manager
Florida Supplement
06.2014 - 05.2015
Manufacturing Supervisor Dry Dosage
Watson Laboratories
01.2009 - 01.2013
Unit Coordinator/Supervisor (Cleaning Science Department)
Watson Laboratories
01.2006 - 01.2009
Unit Coordinator II / Mfg Supervisor (Acting) – Oral Contraceptives
Watson Laboratories
01.2004 - 01.2006
Unit Coordinator
Watson Laboratories
01.2002 - 01.2004
Manufacturing Operator
Watson Laboratories
01.2001 - 01.2002
International Management -
Externado University
Business Administration -
Agraria University