Edward Parent Email & Phone Number

Wilson, Nc, Us

Gaithersburg, Maryland, Us

 Process Validation, Engineering Studies, Risk Assessments, Media Fills, and Validation Documentation with the purpose of scale-up and transfer the manufacture of Parenteral dosage forms, formulation and fill finish. Risk Assessments for PUPSIT, Sterility Assurance, Cross-Contamination, Extractable and Leachable, Critical and Key process parameters. Design single use assemblies for filling and PUPSIT. Write and execute Engineering studies and PPQ protocols and Reports. Write SOP’s.

Basel, Baselstadt, Ch

Technical Transfer of Oral Solid Dosage. Including validation, engineering studies, risk assessment, establishing critical process parameters.

Develop Processes to manufacture medical device for customers under GMP at the Flex Medical Device Design Center.

Dallas, Texas, Us

Update Quality System and Quality Manual based on ISO 13485. Conduct internal audits. Host external audits. Write quality procedures. Maintain NC and CAPA system. Facilitate management reviews, track quality KPI's, Supplier evaluation and control, Review batch records. Conduct impact assessments and root cause analysis.

Project manager/responsible to successfully bringing a line of sterile polymer based excipients from inception to market. Scale-up and technical transfer of manufacture excipient PLGA biomaterials. Develop Scale-up and technical transfer plans. Develop and implement new manufacturing processes. Write SOP’s, Work Instruction, and Development Reports. Use quality by design for development. Conduct PHA, PSSR, process FMEA, determine critical process parameters. Product Development. Mentor junior staff.

Scale-up and optimize the manufacture of intraocular lenses using Design of Experiments. Develop and validate cleaning cycles. Write IQ OQ protocol for parts washer. Statistical analysis of experimtal data. Write SOP’s, Work Instructions, Development reports.

Hayward, California, Us

Technical transfer and scale-up of parenteral emulsion using Quality by Design. Worked on team to develop and implement technical transfer plan. IQ OQ new equipment.

Support and implement Cleaning Validation of a newly installed Clean-In-Place system. Work with cross functional teams to troubleshoot and improve CIP and SIP cycles. Support IQ OQ of new system, Write and review SOP’s and protocols. Supervise and train junior staff.

Us

Key Results:Transfer technology of topical emulsions and OTC drugs and to bring these products form bench to large scale manufacture. Optimize and streamline manufacturing processes. Work to improve and develop formulations of emulsions using design of experiments. Optimize mixing and homogenization methods. Track and improve process capability of manufactured products using Minitab. Working under GMP. Write SOP’s, Protocols, and technical reports

Key Results: Developed and Patented polymeric biomaterials for drug delivery, soft tissue augmentation, medical implant, and opthalmic use based on bio-polymer hydrogels. Patent issued. Developed and patented a surface active modified natural polymer for formulations in topical drug delivery. Patent issued. Scale up and manufacture of polymeric ingredient to a contract manufacture improving the manufacturing process, increasing batch size, and improving the critical process parameters. Developed and scaled-up a topical cross-linked hydrogel sold to the cosmetic industry.

Paris, France, Fr

Worked in large groups on several projects simultaneously to develop new drug delivery systems, new polymeric based biomaterials, and to develop and scale up new products. Some projects I worked on include:  Developed and scale-up hyaluronic acid based medical device Developed hydrogel based drug delivery system for Intraarticular drug delivery.  Developed opthalmic drug delivery for corneal wound repair. Developed coatings for polyurethane catheter. Develop delivery systems for proteins, peptides, and small drugs. Developed prototype of a drug eluting stent coated with cross-linked Hyaluronic acid Develop and scale up new implantable arthritis device based on biomaterial Developed and patented a HA – drug conjugate for targeted drug delivery of alpha-interferon  Developed an opthalmic drug delivery system for corneal wound healing  Troubleshoot manufacturing Atomic Force Microscopy  Radiation Safety Officer  Supervised Biochemistry R&D labs, including Safety and efficacy, Drug Delivery, Material development, and Tissue Culture

Key Results:Worked at a start-up company with 9 other people, Biomatrix grew to a company with 500+ employees worth $750M. Worked to develop biomaterials marketed as medical products such as Synvisc, Hylaform, and Hylashield.  Developed and implemented testing procedures for biocompatibility and efficacy to qualify Hyaluronic acid based medical devices. Developed viscosupplement device for inter-articular, soft tissue, and opthalmic use. in-vitro compatibility with blood and tissue  Immune response and ELISA development  Degradation and metabolic clearance studies.  Studied hyaluronan in bodily fluids, i.e. the vitreous and synovial fluid  Studied receptor binding, endocytosis, cell adhesion, and proliferation  Supervise technical staffPurified and characterized enzymes, and proteins Tissue culture and organ culture. Write SOP’s, Protocol’s, Reports. Developed and evaluated a platform of Drug Delivery Systems for a variety of applications.Worked to bring products from bench to pilot plant, prepared products for clinical trial, Key scientist that brought several products from concept to clinical trial or market including;Synvisc(R), Hylaform(R), Hylagel(R)Uro, Hylagel(R), Hylasine(TM), Hylashield(R), Hylagel(R)Eye, Hylagel(R) Vasc, Captique(TM).

Biochemistry And Cell Biology

Bs, Biology