Engineer Customer Service

David F. Ellis

Franklin Lakes, New Jersey

201-***-**** *********@*****.***

TECHNICAL OPERATIONS / SERVICES ENGINEER

Adept at composing, reviewing and executing submission, alternate API and validation batch documentation, granulation and modified release processing and drug product development. Mentor junior staff and provide training and technical assistance. Participate in all Safety Committee initiatives.

Process Validation Commercialization Technical Transfer Process Improvement Product Optimization Formulation Development Material Interactions Relationship Management Cross-Functional Communication Process Mapping and Training Scanning Electron Microscopy

EXPERIENCE

PAR PHARMACEUTICALS, Chestnut Ridge, NY Oct. 2011 – Sept. 2017

Senior Specialist (Jan. 2013 – Sept. 2017)

Technical Operations Specialist (Oct. 2011 – Jan. 2013)

Led process validation, technical transfer and scale up of solid dosage processes, commercialization, process optimization, troubleshooting, quality failure investigations and post validation process/product monitoring.

Composed, reviewed, and executed process validation protocols and final reports, as well as manufacturing batch records in support of submission batch, alternate API and formulation and validation batch manufacturing.

Mentored junior Technical Operations staff and Manufacturing staff and provide training and technical assistance to same.

Participated in deviation investigations, change control documentation and CAPA recommendations in conjunction with QA group.

Participate in new equipment IQ/OQ/PQ executions and cleaning validations.

Coordinate documentation and processing activities and travel to CMO sites for project oversight.

Work closely with QA, QC, Regulatory and Production groups to insure timely execution of processing and testing.

Participated in Company Safety Committee covering every day safety issues and potent compound Manufacturing.

Monitor commercial products for Continuous Improvement opportunities.

GLATT AIR TECHNIQUES, Ramsey NJ Oct. 1998 – Oct. 2011

Technical Services Engineer (Jan. 2007 – Oct. 2011)

Managed technical transfer and scale up of solid dosage processes, process optimization and troubleshooting both in house and in the field.

Created, reviewed, and implemented process manufacturing records, protocols and reports to support submission, validation and clinical supply manufacturing.

Prepared and presented technical presentations and training at industry symposiums and client sites.

Guided junior Process Scientists and manufacturing staff and train same.

Participate in new equipment IQ/OQ/PQ executions and cleaning validations.

Participate in deviation investigations, change control documentation and CAPA recommendations.

Technical resource for Glatt Sales and Formulation departments and liaison for client Scientists processing at Glatt facility and customer sites.

Scientist, Formulation Development (Jan. 2002 – Jan. 2007)

Collaborated with Formulators on product and process development activities for various solid dosage forms, modified/controlled release applications, and scale up of same.

Utilized creativity in overcoming process problems and improvised techniques.

Prepared statistical data for Director of Formulations and anticipated necessary actions in ongoing project work.

Lab Technician (Oct. 1998 – Jan. 2002)

Prepared equipment and solutions and conducted Solid Dosage Processing for various customers utilizing a wide variety of techniques and applications of Solid Dosage Technology.

CHEMIPHARM, Ramsey, NJ Apr. 1998 - Oct. 1998

Technical Support/Inside Sales/Customer Service

Provided Technical Customer Support and Inside Sales Assistance for Laboratory Equipment Supplier

WAKEFERN FOOD CORPORATION, Elizabeth, NJ Apr. 1996 – Mar. 1998

Warehouse Supervisor, Distribution Center

Oversaw shipping and receiving operation, inventory control, and general Warehouse Management in a union environment with 180 associates in 450,000 sq. ft. facility.

Handled independent projects for Operations Manager and covered for Shipping Coordinator in his absence.

David F. Ellis

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201-***-**** *********@*****.***

ADDITIONAL RELEVANT EXPERIENCE

THE GRAND UNION COMPANY, Carlstadt, NJ

Warehouse Manager

Promoted to oversee 12 supervisors, 10 clerks and 150 union associates in regional distribution center. Oversaw shipping, receiving, inventory control and daily operations of a 300,000 sq. ft. dry grocery and refrigerated facility. Participated in labor contract negotiations.

Warehouse Supervisor

FABRICOLOR, INC., Paterson, NJ

Production Supervisor

Directed actions of plant staff in Blending, Spray Drying, Tray Drying, Milling, Shipping, Warehousing and Raw Materials Departments for a Textile Dye Manufacturer.

EDUCATION

B.S., Wood and Cellulose Science, West Virginia University, Morgantown, WV

LEADERSHIP EXPERIENCE

Instructor, “Current Practices in Fluid Bed Processing” Seminar at Glatt Air Techniques (2002 – 2011)

Instructor, “Hands on Course in Tablet Technology” University of Tennessee (2007 – 2011)

Speaker, “Industrial Pharmacy Symposium” – St. Johns University (2009)

“Mixing Consultants” – Advances in Pharmaceutical Process Design (2009)

various Glatt Customers – (2007 – 2011)

cGMP Training, Monthly “Current Good Manufacturing Practices for Pharmaceutical Production”

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