Freddy Padilla Email & Phone Number

Philadelphia, PA, US

San Ramon, California, US

· Managed and provided oversight for utilities and automation CQV deliverables.· Reviewed utilities commissioning and qualification protocols and punchlist items to ensure they are ready for turnover to the client· Assisted in authoring and implementing site maintenance policies and procedures that are compliant with industry expectations and site.

San Ramon, California, US

• Provided Process Engineering support for a facility expansion and new filling line.
• Supported clients in starting up new facilities and authoring operational procedures for facility cleaning, gowning, and access
• Conducted a Time and Motion Study, outlining processing steps and time constraints for process optimization for bulk drug substance manufacturing
• Consulted and authored a Validation Master Plan for the qualification of facility and equipment for a viral vector gene therapy facility
• Authored and reviewed equipment specifications and data sheets for GMP manufacturing and processing equipment

Brentford, Middlesex, GB

• Accountable for the sterile manufacture of clinical and developmental supplies, including planning, coordination, manufacturing operations, and line supervision of manufacturing team members comprised of 13 direct.
• Ensure all activities are conducted in full compliance with cGMP's, safety regulations, and critical business requirements.
• Technical subject matter expert for aseptic manufacturing operations within the Sterile Pilot Plant.
• Responsible for managing the introduction of new aseptic manufacturing equipment and technology, ensuring they are fit for GMP use.
• Review and endorse validation life cycle documents as the System Owner, including change controls and qualification packages for various processing equipment and utilities such as parts washer, autoclave, vial washer.
• Business lead investigator responsible for conducting deviation investigations and implementing CAPAs.

San Ramon, California, US

• Project Lead: Client – Lonza Group Ltd
• Organized and managed all validation deliverables for powdered media facility upgrade project
• Qualified GMP manufacturing area for ISO-8 classification, including HVAC and cleaning requirements
• Developed URS and performed Risk Assessments for powdered media manufacturing equipment
• Worked with 3rd party vendors to develop and complete commissioning of equipment and facilitiesSenior CQ Consultant: Client – Sanofi Pasteur Ltd.
• Organized the validation lifecycle and qualification of an Emerson DeltaV Process Control System to be used in a biological manufacturing environment

Blue Bell, PA, US

• Client: GlaxoSmithKline – Upper Merion, PA
• Met daily with client on-site to support and improve validation/compliance program for clinical manufacturing facility
• Managed the decommissioning of a R&D Clinical Manufacturing Facility surmounting deadline and budget expectations
• Performed validation maintenance, commissioning, and qualification of aseptic processing equipment
• Addressed various quality discrepancies and implemented corrective and preventive actions to ensure compliance with manufacturing and change management
• Worked with multiple departments to document and manage change control activities impacting the qualification of processing equipment, computerized systems, and utilities used to support aseptic processing

Toronto, Ontario, CA

• Client: Ben Venue Laboratories
• Provided technical consulting for improving freeze dryer and controlled temperature storage unit qualification practices and procedures under consent decree conditions
• Provided technical support in various periodic reviews, validation deviations, change actions, and change controls using TrackWise
• Advised and performed validation studies on production equipment used to manufacture sterile drug products

Ivyland, Pennsylvania, US

• Participated in sterilization, aseptic filling, environmental monitoring, lyophilization, inspection, and packaging activities
• Effectively processed cytotoxic, highly potent compounds and biologics using isolators and containment procedures
• Performed investigations and implemented corrective and preventive actions to ensure compliance in areas such as facilities maintenance, microbial control, operator training, and equipment use
• Proposed in house testing for water sampling, saving the company approximately $5,000 annually
• Revised and reviewed master batch records for use in drug manufacture and aseptic processing

• Collaborated with scientists while researching chemicals to be used in formulation for freeze drying.
• Formulated and filled active pharmaceutical ingredients in a clean room environment.
• Performed finished product testing such as reconstitution, pH sampling, and cake analysis. Edited and drafted SOPs to be used to train employees in laboratory practices.

Olean, NY, US

• Generated over $8,200.00 in personal sales part time.
• Collaborated with the sales manager during interviews, hiring, and training new representatives.
• Motivated and inspired employees in order to help create sales and build team morale.
• Coached lessons on time management, goals, closing sales, and gaining sales leads.
• Oversaw the day-to-day operations in the absence of the Pilot Sales Manager.

St. Louis, Missouri, US

• Prepared and used chromatography columns in order to purify and manufacture protein based therapeutics.
• Monitored and operated software used to control semi-automated chromatography skids.
• Assembled cassettes in conjunction with TFF membranes for protein purification.
• Cleaned and steamed machinery and equipment for aseptic use in compliance with cGMP standards.

Master Of Business Administration (M.B.A.), Pharmaceutical And Healthcare Business

Biological Sciences, Biological And Physical Sciences