Jose M. Del Toro

*** ***** ** *** *******, MA ***52

787-***-**** ad36mq@r.postjobfree.com

http://www.linkedin.com/in/deltoroj80

CAREER SUMMARY

Production leader with over 15 years of experience in the Biopharma, Pharmaceutical, and Medical Device Industry. Managed high-performance teams in Aseptic Sterile Filling operations. Provided leadership during shutdowns, product transfer, and start-up processes while adhering to FDA, cGMP, and other regulatory requirements. Experienced in Process Qualification and Execution (IQ, OQ, and PQ), Computer System Validation, Change Control, and cost-saving projects. Experience also includes Maintenance and Calibration of production equipment.

EDUCATION

MBA, Industrial Management (GPA 3.78/4.00)

Universidad del Este, Carolina, PR.

Bachelor’s in Science, Electronics Engineering Technology (GPA 3.31/4.00)

Universidad Interamericana, Aguadilla, PR

COMPUTER SKILLS

SAP, TrackWise, Kronos, MP2, Software Validation, Blue Mountain, and Veeva. Microsoft Office Words, Excel, PowerPoint, Outlook, Access, TEAMS. Smartsheet (MS Project). MasterControl.

QUALIFICATIONS AND SEMINARS

Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP)

Good Clinical Practice (US FDA Focus) – Expires May 2026.

Compliance with Regulation 21 CFR Part 11 (Electronic Records and Signatures)

ISO 9000 Internal Auditor

Instructor Development Workshop

Chemical Curriculum Course

Programmable Logic Circuit (PLC) Level III

PROFESSIONAL EXPERIENCE

uniQure. Lexington, Massachusetts. November 2020 – November 2023

Quality Lead

uniQure is a Biopharma performing Research and Development aiming for Gene Therapy for Hemophilia and Huntington’s Disease.

Working with Strategic Quality Leadership at uniQure

Led Change Control activities in the QC department and partnered with support teams related to compliance aspects of changes. Led Changes Assessments. Facilitated multidepartment discussions.

Proactively manages the progression of tasks for timely closure of changes.

Provided support for QC site operations, including facilities, lab operations, and IT operations. 21 CFR Part 11, Data Backup and Recovery. Changes to URSs and SOPs.

Generated, executed, and performed post-execution review and approval of analytical method validation protocols and reports.

Provided Analytical QC approval of Non-conformances (NC), Corrective and Preventive Actions (CAPA), and change controls. Used fishbone diagrams and 5 Whys.

Equipment Quote, Capital Assets Requisition, Installation Qualification, Equipment Decommission

Review and approve Certificates of Analysis (COAs) to support equipment release for GMP use.

Analytical Equipment, Stability Chambers

Akorn Inc. Decatur, Illinois. July 2019 – January 2020

Production Manager

Injectables and ophthalmic aseptic filling. Isolators. Liquid and lyophilized products. Ampoules

Formulation, Equipment Preparation, Glass Preparation, Filling, and Capping

In charge of two Production Supervisor and 35 operators

Approval of Change Control, validations, Standard Operating Procedures (SOPs), and Batch Records

Provided Management approval for Investigation closures.

Led the daily communication hurdles with all departments in the shift.

Guided to develop production line leaders.

American Regent, New Albany, Ohio. June 2014 – July 2019

Inspection/Packaging Supervisor

Led a start-up operation.

Redesigned a manual process operation with an improvement in output of 500%

Authored SOPs. Batch records creation. FDA submissions. DEA products. KPI.

Track of Operating Equipment Effectiveness (OEE)

Protocol preparation and execution of IQ, OQ, and PQ.

Generated change requests for packaging material

Continuous Improvement. Introduced 5S and lean manufacturing concepts to the organizational culture.

Employee selection and training

Led a team of 30. Prepared performance reviews. Coached and mentored.

Reviewed and approved timesheets and ensured the transmittal of information to Payroll.

Prepared staff for the next level. Made recommendations for promotions.

Led Root Cause Investigation and Corrective/Preventive Actions (CAPA) for packaging.

Bausch & Lomb, Tampa, Florida. November 2010 – February 2014

Manufacturing Supervisor

Managed aseptic sterile filling and packaging for the 3rd shift.

This plant fills plastic bottles with plastic caps and spray pumps. Solutions, suspensions, and ointments.

Wise Owls (OSHA) environment (Continuous Safety Surveillance)

Employee hiring, performance review, employee relations, attendance, training, and compliance.

Investigations of non-conformance and corrective actions (CAPA)

Direct reports included 1-Group Leader, 7-Line Leaders, and a staff of 35.

Wyeth, Carolina, PR. 2003 –2008

Manufacturing Supervisor

Formulation, Freeze drying (Lyophilizers), and Capping. Single-use filtration.

Investigations, root cause, Corrective/Preventive actions. Effectiveness check.

Change Control

Failure Mode Effect Analysis (FMEA)

Saved $30K/year in scrap.

Guidant, Dorado, PR. 2002 –2003

Facilities Supervisor

Curtis Instruments, Carolina, PR. 2000 - 2002

Maintenance Supervisor

Baxter IV System, Carolina/Aibonito, PR. 1997 - 2000

Production Supervisor

Lutron SM, Inc., Humacao, PR. 1995 - 1997

Facilities Coordinator

Hewlett Packard Aguadilla, PR. 1990 - 1995

Process Technician/Operator

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