Operational Team

Mr. Mills has nearly 20 years of pharmaceutical professional experience with a focus on commissioning, qualification and quality assurance programs.  Having worked at production facilities for the top pharmaceutical companies in the world, Mr. Mills brings a depth of experience to any GMP project.  He has the ability to manage, develop, install, commission, calibrate and maintain environmental, process and utility control systems.  Mr. Mills is skilled in the selection and qualification of critical instrumentation and his expertise is highly sought by the industry in the establishment of instrumentation standards and calibration procedures.  For a full CV click here.

Mr. Moodley is a seasoned pharmaceutical industry professional with over 30 years of experience in the development, scale-up and manufacture of extended-release medications and other drug delivery technologies.  Mr. Moodley represents the bridge between drug discovery and commercial development.  In over 20 years with Élan Pharmaceuticals alone, he developed and introduced to the market Cardizem, Veralan and Theolan – all in extended-release formulations.  Prior to joining Élan, Mr. Moodley was with Controlled Medications, Inc., which was established as a generic contract manufacturing company by Dr. Donald E. Panoz founder of Mylan Laboratories and Élan Corporation PLC.  The primary objective was to exploit the generic markets of South East Asia, Africa and Europe.  In excess of 500 million doses of tablets, capsules and liquids were manufactured annually.  Products included antibiotics, pain relief, anti-hypertensives, TB-related, vitamins and others.  He was responsible for the Scale-Up of all products, supervising 15 Engineers and Technicians and Validation of process equipment as well as qualification of vendors.  The sourcing and qualification of contract manufacturing companies, project management, construction, set-up of new facilities, and procurement of equipment are all areas where Mr. Moodley is expert.  For a full CV click here.

Mr. Saltsgaver is an innovative entrepreneurial Engineer with over 19 years experience in an advanced engineering environment.  A strong leader able to bring long-term strategies into current business needs, Mr. Saltsgaver has a demonstrated creative ability to add value to new processes, products and technologies. Outstanding management, team leader and interpersonal skills, Mr. Saltsgaver brings superb project management abilities to any pharmaceutical or biotech endeavor with significant experience in Project Management, Validations, Sterile Fill, cGMP, Packaging, 21 CFR Part 11, Kaizen, Scale Ups, Commissioning, SOP’s, FMEA’s, Process Improvement, ISO, Change Control, Functional Specifications, Bid Specifications, Aseptic Processes, Capital Projects, Acceptance Testing and 8D Quality Methods.  For full CV click here.

Dr. Shulenberger’s basic philosophy when writing a grant application, imposed on developing teams, is to carefully define the question, and then build a dream-team that disregards topical, administrative and university boundaries.  The effort is successful: he has been deeply involved in upwards of $1.5B of successful proposals, ranging from $15k to $86.6M in a single grant.  This work involves assembling multidisciplinary teams, usually with members from many departments, often from several universities and/or countries, to do complex large-scale research projects. Dr. Shulenberger’s job is to assemble a group, teach it how to work together, send a successful proposal out the door, and then salute as the group marches off to have fun doing the proposed work.  For Full CV click here.

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RCMills Resume BW
Joey Moodley
Duane Saltsgaver