Engineer Chemical Engineering

Joseph H. Behyan

**** *. ********* *****

Anaheim Hills, California 92808

Home: 714-***-****

Cell: 714-***-****

Email: *******@*****.***

Joseph Behyan

OBJECTIVE: A Sr. Process Engineering / Product Development / Formulation Position in a pharmaceutical plant.

SUMMARY

B.S in Chemical Engineering + M.S in Environmental Engineering Management

24+ years of technical experience with process engineering, formulations, continuous improvements in the pharmaceutical Solid dosage industry, including extended/delayed release products

Handled all technical functions including process development, Scale- up, Tech-transfer, Process validation/documentation, process optimization, formulations, production support etc.

Extensive experience with unit operations like mixing, blending milling, drying, tablet compression, coating, coloring, encapsulation soft gel and packaging.

7+ years of experience with CMO companies like Jarrow, Anabolic, Leiner (NBTY)

Experience with continuous improvement using TQM, SPC. and Root cause analysis.

Experience with validation support for process, cleaning, equipment etc.

Familiar with process controls/automation using PLC/SCADA systems.

Ability to work for medium sized fast paced company.

Excellent team player. Work well with cross functional teams, production and external customers. Travelled to customer sites as needed.

Experience:

(Wakunaga of America., Co. Ltd.), Mira Loma, California March 2018 – Present

Manufacturer of Nutritional supplements

Senior Product Development Process Engineer

Develop, modify and / or adjust new product and / or current product of formulation, production method, machine condition, and package material

Operate mixing, tablet, capsule, coating and other machines, upon assignment. Include set-up, and startup

Perform complete process / equipment validations

Responsible purchasing compression as well as encapsulation machine. Complete validation of the equipment, writing protocol for Process qualification / verification

(Nature’s Made) Pharmavite, San Fernando, California September 2013 – March 2018

Manufacturer of Nutritional supplements

Senior Process Engineer / Formulator

Reason to leave: Commute

Independently provided effective and functional technical support for all dosage form for product and process optimization. Provided technical expertise to manufacturing and Product Development to assure the smooth and timely transfer of technology.

Independently developed process improvements related to all solid dosage / soft gels and/or delivery systems.

Prepared, reviewed and/or approved technical documents to include but not limited to: Technical Reports, SOP’S, Master Batch Records (MBR’s), Change Controls, Cost Quotes, Product and Process Verification/Validation Protocols.

Troubleshoot and investigated manufacturing problems, monitored the processes and optimized formulations and/or processes as required.

Maintained awareness of current developments in the functional discipline. Developed a network of outside contacts such as vendors, consultants, educators and appropriate continuing education courses. Worked with equipment suppliers and cross-functional team to develop a cost-effective and working production process.

Process Engineer for soft gel line. Increased the Technophar line speed encapsulation machine from 4 rpm to 6 rpm through Process validation and qualification.

Responsible for off line symatix inspection machine. Completed process qualification, training operator and supervisor.

Involved with process qualification for DelMix 1300 &Delmix 1000 liter mixer / homogenizer.

improved the high viscosity Gel Mass to run at higher speed on encapsulation machine

Expert on Enteric coated Fish Oil Soft Gels

Jarrow Industries, Inc, Santa Fe Spring, CA October 2012 – Oct 2013

CMO for Nutritional and prescription nutritional products

Sr. Formulation Scientist / Process Development Engineer

Coordinate outside contract manufacturing for lower volume tablet and soft gelatin capsules. Involved with auditing and qualifications / write formula and protocol procedure

Organized, monitored and prioritize the operation for the Encapsulation, Tablet Compression and Tablet Coating department personnel

Trained all new R&D and manufacturing employees

Formulated tablet formulation for dietary supplements, and transferred the technology to manufacturing stages

Generated raw material specification, and master formula

Process Engineer for scale up, feasibility, technology transfer and process validation for nutritional and OTC pharmaceutical solid dose products

Responsible for drafting, finalizing, approving and executing installation, operation and performance protocol validation documentation for tablet, two piece Hard shell equipment qualification

Formulated new nutritional supplement, drink mixes from phase I through phase III development to meet market requirements, create master formula for all new nutritional product, establishing formula, physical parameter, specification and manufacturing procedures for all new product based on pilot trial runs

Coordinated formulation development, pilot batch execution and process scale-up operations for new product line with product development unit and reformulation, manufacturing, troubleshooting and process optimization of existing formulation, with production personnel

Formulated new products in collaboration with marketing, science, and global operations to ensure consistency with client product specifications, product format, label claim, applicable regulations and manufacturing capabilities

Work seamlessly with operations, regulatory, quality assurance, and affiliated company source including manufacturing in raw materials sourcing and qualification providing specification and ensuring quality of materials sourced, as well as with external manufacturing sources

Evaluated and involved in installation and process validation protocol of new Bosch GFK 2000 capsule machined

Evaluated and set test method based on ISO, and USP requirements

Experience with DOE, write specification, test method and validation protocol

Hands on experience on tablet press, encapsulation, fluid bed granulator and tablet coating

Colorcon Inc, Santa Ana, CA Sept 2003 – Sept 2012

Development and Manufacturing of Pharmaceutical coloring for table coating

Senior Scientist

Assisted customer with outsourcing of their coating and tableting needs. Help outside contractor with troubleshooting and any problems involved with manufacturing of solid dosage products.

Novel Formulation Design experience pertaining to solid dosage forms with functional coatings, specialized functional resins and modified hydrophilic matrices to provide site and time specific release of the actives and barrier properties to the finished product in both OTC pharmaceutical and nutritional industry

Scale up feasibility trials, technology transfer and process validation of OTC pharmaceutical solid dose products.

Experience base includes understanding of wet & dry granulation processes – roller compaction, beads drug loading, extrusion- spheronization- blending, high speed tablet manufacturing, SMI instrumented tablet press, aesthetic and functional coating and hard gelatin capsule Mfr.

Provided technical assistance to customers in terms of immediate and modified release solid dose formulation development, trouble shooting and small scale and commercial scale trial support. Involved in internal and external training seminars on coating process development, optimization and scale-up and core formulation development. Managed projects also at customer site.

Planned, managed and executed all coating seminar. Conducted coating presentations at customer site/operator training. Assisted customers with start-up of the new tablet coating equipment and troubleshooting the existing ones. Discussed regulatory issues with customer on all aspect of the pharmaceutical coating products that includes functional coating. Introduce and promote Methocel, Ethocel and polyox raw materials

Led technical application, discussions with customers and sales teams using the various technical information tools available

Assisted customer with core formulation and guide development and troubleshooting strategies

Recommend optimal color / pigment selection based on customers desired target markets and associated regulatory requirements. Coordinate communications between the customer and Colorcon Regulatory department.

Assisted customer with benefits of Colorcon Modified Release Technologies. Recommend their application based on customer’s drug release, formulation and processing requirements.

Coordinated the provision of Colorcon product samples to customer in a timely fashion in close cooperation with the sample lab. Provided clear and detailed instructions to the sample laboratory.

Traveled to customer’s R/D and manufacturing sites to promote the use of Colorcon products.

Prepared Technical Service project reports, itineraries, and lab work reports

Prepared and presented technical information (oral and written) for both internal and external training seminars and product promotion events

Promoted Colorcon capabilities, applications data sheets and technical information to target customers in the pharmaceutical and food/confectionary industries

Anabolic Laboratories, Irvine, CA March 2001 – Sept 2003

CMO for Nutritional and prescription products

Senior Scientist formulation

Responsible for developing new and improving existing vitamin, OTC and prescription drug solid dosage products in quality, timely and cost efficient manner

Evaluated and approved raw materials and identified appropriate vendor; conducted engineering studies and assessed project feasibility; designed and monitored scale-ups; submitted completed pilot batch samples for stability testing; analyzed data and developed process controls; assisted in technology transfer to production; provided production floor technical support; assured reproducibility, quality in all product and processes; investigated non-conformance results and took corrective action to prevent reoccurrence

Approved raw material specifications, master formulation and bulk specifications; developed and wrote protocol documentation for equipment, blend and cleaning validation execution; collected relevant documentation for ANDA and NDA drug application submission to FDA

Enforced Current Good Manufacturing Practice, SOP’s, equipment and safety practices

Converted majority of products requiring wet granulation and solvent-based coating into directly compressible and aqueous-based coated formulation resulting in material and labor cost saving.

Leiner Health Product, (NBTY) Garden Grove, CA Dec 1997 - Mar 2001

CMO for Nutritional and prescription Nutritional products

Senior Scientist / Process Engineering Dept

Involved and coordinated outside tabletting and coating contractor for low volume product as well as all gelatin base products. Audit the outside vendor, review documentation / process validation and labelling of the products.

Formulated all new direct compression / granulation formula for Multi Vitamins, Minerals and Herbal products.

Plan and executed process optimization; developed innovative process technologies

Managed product development projects, including formulation, process scale-up

Provided technical / production support to R&D and production

Scale up feasibility trials, technology transfer and process validation for nutritional and OTC pharmaceutical solid dose products

Experience includes understanding of wet and dry granulation processes, roller compaction and extrusion, spheronization, blending, high speed tablet press & continuous coating equipment, manufacturing, aesthetic and functional coating, hard gelatin capsule, and capsule filling

Experience and understanding of cGMPs and related protocol development and documentation

Developed new formulations for the Softgel, Tablet and Capsule market

Assisted in design of a new Softgel Production Facility for Fish Oil Softgels

Nutrilite Products Inc – Buena Park, CA May 1993 - Dec 1997

CMO for Nutritional products for AMWAY

Sr. Process Engineer / Pilot Plant

Managed and supervised Pilot Plant process engineer and technicians, responsible for all annual reviews, and promotions

Scale-up materials, Nutritional Supplements from R&D to manufacturing scale

Identifying elements of process control, implementation and validation of Pilot Plant equipment

Specify quality improvements, equipment cost and process evaluation per tablet

Analyzed process through plant trials and set specification by SPC & Design of experiment to implement and generate the master formula

Experience in granulation, blending tablet /capsule press

Conduced process validation on all new product and processes

Prepared budget proposals, supervision of installation, time schedules, establish guidelines and quality control procedure

Evaluated and sourced raw materials based on quality attributes and cost; created process flow based on critical control parameters by pilot batch design and analysis; assigned lot size according to process scalability and equipment capacity; troubleshoot on the manufacturing floor non-conformance process issue; recommended improvements to achieve batch-to-batch reproducibility

Education & Training

West Coast University, Los Angeles, California

Master of Science Degree, Environmental Engineering Management

California State University, Long Beach, California

Bachelor of Science Degree, Chemical Engineering

University of Wisconsin, Madison; Certificate - Solid Dosage Systems

Tech source, Indianapolis, Indiana; Certificate – Tablet Manufacturing Technology

University of California Los Angeles; certificate – Composite Material, Processing, Quality Assurance and Repair engineering

The center for Professional Advancement, NJ; Certificate - Current Good Manufacturing Practice (CGMP) Regulations

University of Dayton, Ohio; Certificate - Shainin Quality Improvement – Statistical engineering

Contact this candidate