Robert Hauser Email & Phone Number

Danbury Ct

Responsible for:1. The establishment of a formal Quality Management System. [Successfully passed 2 independent audits]2. The establishment of facility, quality and manufacturing related SOPs3. The establishment of a formal Quality Assurance and Quality Control operation.4. The establishment of a formal Stability Program for multiple drug product candidates.5. CMC development for lead candidate PER977 - Ciraparantag Acetate

Danbury Ct

Post-Clinical Formulation and Process Development of 6 separate products including BIOD-123 and BIOD-531 - injectable and oral products.Principal Scientist for 2 NIH SBIRsNovel Drug Delivery Systems development - Insulin and hormone peptides.Head of all Technical Services (analytical method development; process and cleaning validation).Head of all outsourced ManufacturingCMC SpecialistPatent Chemist

Directed Product, Process and Analytical Methods development and transfer to CMO's. Oversaw CMO management and compliance. Responsible for Quality Assurance until QA Director hired.

Baltimore, Maryland Area And Gulfport Ms

Responsible for all new Product & Process Development for an extensive line of liquid generic and OTC drugs; Technical Services including process and cleaning validation, process and assay development and company Stability program; Supply Chain; Regulatory Affairs (ANDA submissions; compliance) and Executive Management.

Responsible for establishing the Biological Laboratory Testing operation for a Homeland Defense Company. Commissioned a BSL-3 Laboratory and initiated business operations (Testing and Contract Research) for that segment of the business and assumed operational and business development responsibility for an existing Chemical Surity Laboratory operation. Position required a Secret/Top Secret security clearance. Wrote the Technical portion for 3 US Government project proposals - one being successful - technical management of Dugway Proving Grounds (UT).

Led the dramatic turn-around of a $32 million Therapeutic Business Unit; Planned, coordinated and reorganized (for improved Quality and Productivity) Clinical Operations (US and Canada), a $188 million operation.

Victoria, Canada

Hired by the Board of Directors to develop a Strategic Operating Plan for a developmental stage Biotechnology Company developing a vaccine for HPV. Work closely with the CEO to improve day to day operations and to optimize sales of the companies diagnostic products. Met all Board expectations well in advance of expected timelines.

Rockford, Illinois Area; Rolling Meadows, Il

Founded and commissioned a successful contract clinical packaging company. Responsible for all business development and Operations for 2 facilities. Business was sold to primary investor. Designed, developed and launched an electronic blister package (ExACT CM) that was designed to record the dispensing (time, date and position) of clinical drugs from a blister card in clinical trials (used in 16 clinical trials).

Ft. Totten, Ny

Medical Service Corps Officer (68C); Operations & Intelligence Officer (S2/S3); NBC Officer, Physical Security Officer, Mobilization Officer, Unit Field Training Officer, Primary Weapons Instructor, Unit Safety Officer and Unit Biochemist for the 344th General Hospital.Attached to the 310th Field Hospital (1984-86) as Food Service Officer (Unit won the Best Food Service Award in the 77th ARCOM)Attached to the 817th Evacuation Hospital (1989 -91) as Unit Supply Officer (S4), Mobilization Officer and Field Training Operations Officer.

Melrose Park Il

Responsible for all QC/QA for the US Sterile Products Operations (multi-facility operations).

Rochester, New York Area

Infant vaccine development and FDA approval; Facility commissioning with a complete systems validation; HibTiter development and product approval.

New York City

Senior Quality and Technical Services executive for Sterling Drug NA. Responsible for the Quality Operations and cGMP compliance for 9 North American plant sites.

Rouses Point, Ny

Responsible for the Quality Control laboratories, Quality Assurance and Validation efforts for Ayerst.

Directly involved in product development. Instituted a Process Development laboratory; developed numerous analytical methods for new products; performed forensic investigations to assess product /process failures.

Various

Qualified Mechanic and NATOPS Qualified Crew chief on the CH-46 and CH-53 helicopters; Flight Line Chief; Maintenance Chief; MAG-49 Intelligence NCOIC [Top Secret]Expert Rifle and Pistol

Teheran, Iran

Medical school instruction in Biochemistry; School of Allied Health & School of Nursing instruction in Chemistry. Curriculum development for all programs; Provide department leadership in resource development.

Brooklyn, Ny

Performed basic biochemical and biophysical research on artificial lipid-bilayer membranes and liposomes (including the liposome fusion mechanism).

Phd, Bioorganic Chemistry, Honors

Activities and Societies: American Chemical Society; Lecturer - Hunter College; RugbyIntensive study in Bio-Organic Chemistry

Ba, Chemistry

Activities and Societies: President, American Chemical Society Affiliate Captain - Swim Team Member of the Baseball and Rugby Teams

Science Diploma, Science, A-

Activities and Societies: Swim Team; Honor Guard

Diploma, General Studies

Activities and Societies: Boy Scouts