Personal Information: ***** Hillcrest Circle, Willis TX 77318, U.S.A

Email: ac3i1n@r.postjobfree.com

Mobile Phone: +001-936-***-****

Career Summary: Pharmaceutical Scientist with strong Product Development, Project Management, Product Quality, and Regulatory experience. I am fully conversant with the development process from concept to product commercialization with 22+ years of experience in industry. Extensive experience with all pharmaceutical dosage forms, especially solids, semi-solids, and parenterals.

Professional Experience:

Glenmark Pharmaceuticals Europe Ltd

*September 2015 – June 2016

Manager, Special Projects Europe:

I built a strong Team of stakeholders across the company and moved the process forward to submit EU market applications for a multi-billion dollar in-licensed inhalation product.

Established a strong working relationship with external stakeholders in Poland, Czech Republic, Germany and India to facilitate cross-company collaboration with Glenmark stakeholders.

I frequently travelled nationally and internationally to build relationships and monitor project progress, troubleshoot bottleneck issues, and drive projects forward.

Developed project plans to outline key milestones of the project identifying the proper resources to ensure timelines and development costs were met throughout the lifecycle of the project.

Risk analysis to anticipate possible pitfalls and bottlenecks during the project life cycle and navigated or mitigated these risks when necessary

My efforts led to projects always being on time or ahead of schedule, conflict resolution, and a significant turnaround in the culture and atmosphere at Glenmark UK, from a feeling of despair to one of optimism and a can-do spirit.

*My successful management of this effort enabled Glenmark to move projects to Indi and the UK group was later disbanded. At this time, rather than remain and collect unemployment I left the U.K to undergo treatment for an injury which I suffered while travelling in Germany on business. I have been involved in treatment for this injury (lower back injury at L4 and L5), and physical therapy. I am now fully fit and ready to return to the workforce.

Shire Pharmaceuticals, Basingstoke U.K.

**August 2013 – March 2014

Non-Clinical Operations Development Manager (contract position)

I transferred one of Shire’s new ophthalmic acquisitions into the Regulatory systems of the company:

Developed a comprehensive understanding of 3D (Shire’s Documentum System).

Maintained and organized all flies associated with regulatory submissions.

Evaluated development studies for completeness including quality and regulatory compliance.

Managed outsourced development studies undertaken by CROs and outside vendors providing technical guidance where necessary.

**Upon successful conclusion of the above contract, I took a sabbatical and traveled to Belize due to two family medical emergencies. My sister suffered a detached retina and her husband suffered a minor stroke. I was there to help them overcome this period of hardship after which I returned to the U.K to join Glenmark.

Ethicor Pharma Ltd, South East England

+November 2012 – February 2013

Director Product Development:

Jump-stared the Brand New Company of Ethicor Pharma:

Initiated new relationships and negotiated contract terms with new partners, CROs, CMOs.

Managed all technical aspects of new products from concept to market, identifying market potential, developing suitable formulation concepts and advising contractors in technical aspects of the formulation development process.

Reviewed scientific literature of New Chemical Entities (NCE) to ensure Regulatory compliance, performed gap analysis and where deficiencies existed; established a path to compliance and acceptance.

+ Unfortunately, I was forced to terminate the relationship with Ethicor in February 2013 due to non-payment of my salary by the company, from November 2012 to February 2013.

Special Products Ltd, Weybridge Surrey, England

April 2010 – October 2012

New Product Development Manager:

Special Products had a number of products which had been identified by the MHRA as being pharmaceutically deficient. I evaluated these products and corrected the outstanding issues as well as introduced new products to round out the company’s product portfolio.

Managed the efficient and timely development of new products from concept to commercial manufacturing.

I reformulated over 29 liquid and 4 solid non-compliant products which had been removed from the company’s product portfolio, leading to significant enhancement in the product pipeline.

Reviewed and revised the Technical Specifications for ALL the company’s products due to inconsistencies and deficiencies which existed when I joined the company.

Penn Pharmaceutical Services, Tredegar Gwent, Wales.

December 2006 – January 2010

Senior Formulation Scientist:

Significant enhancement of Penn’s product pipeline and formulation development capabilities:

Formulated a novel parenteral nanoparticle drug delivery system, to deliver Dihydrocapsaicin to the heart muscle post cardiac arrest, to mitigate risks for cardiac muscle damage.

Developed a new group of company-owned product Specials, including what may have been the first aqueous Melatonin Liquid product commercially available.

Formulated several new products: solids, liquids, semi-solids, and parenteral, scale-up and technical transfer including supervision of commercial manufacturing batches.

Project Management: authored new Technical Specifications, formulation development reports, maintained timelines, technical assistance for IMPD and CTA submissions.

Morton Grove Pharmaceuticals, Inc. Vernon Hills, Illinois.

August 2003 – May 2006

Senior Scientist:

I led the Technical Development and equipment acquisition effort to establish Morton Grove Pharmaceutical’s’ new R&D Unit based in Vernon Hills:

Developed Generic Nasal Drug formulations including Fluticasone Propionate nasal spray. Authored written methods and SOP’S for incoming new equipment used in the physical characterization of Nasal Sprays as per FDA guidelines. Nasal Spray characterization for Plume Geometry, Spray Pattern, and Droplet and Particle Size Distribution. Developed working knowledge for the use and operation of other new laboratory equipment; and trained other scientists in the proper use of new instruments and equipment.

I led the selection process for identifying CROs, and frequently acted as the primary contact person with their representatives in all aspects of in-vitro and clinical testing. Identified and purchased the instrumentation necessary to equip a fully functional laboratory for Nasal Spray characterization. Also identified and purchased the equipment necessary to fully equipped three other R&D labs, on-site demonstration, supervise and oversee the writing of URS and acquisition, IQ OQ, PQ,SOPs, Validation and finally, training of other MGP scientists in the use of new equipment.

Center for Pharmaceutical Science and Technology

College of Pharmacy, University of Kentucky.

October 1999- January 2003

Formulation Development Manager:

As Formulation Development Manager I led a team which built a fledgling state-sponsored entity into a self-sufficient group of scientists developing traditional dosage forms as well as several later patented novel dosage forms. This grew to a small CRO which generated “a profit” of four million dollars annually.

Supervised and headed a group responsible for the development of several Nasal Spray formulations including: Midazolam Hydrochloride, THC, and Fentanyl Citrate, from proof of concept through manufacturing of clinical batches.

Formulated a novel Amlexanox gel as well as a new paste. Developed a new Recombinant Human Lactoferrin gel formulation. Developed several muco-adhesive gel and Semi- Solid drug formulations. Formulated and supervised the scale-up of all new gel and semi-solid formulations and also supervised the manufacturing of all Development Batches.

Developed new parenteral dosage forms including a subcutaneous gel for long acting drug delivery, a recombinant human lactoferrin product, and an injectable micro-emulsion drug delivery system, to name a few.

Formulated a novel nanoparticle drug delivery system (parenteral) to deliver Doxorubicin across the Blood Brain Barrier.

Acted as interim Quality Control Manager from May 2000 to March 2001 while still fulfilling my duties as Formulation Development Manager.

Guided Pharmaceutical Science graduate students in the principles of formulation development, particularly in the area of Semi-Solid formulations and trans-mucosal drug delivery.

Education: Brooklands Technical College, Wyebridge, Surrey, UK

T.E.C Certificate (HND/HNC equivalent)

Currently enrolled in the PIAT program at The University of Manchester

MSc in Pharmaceutical Science

Proficient in:

Development of Oral Solid dosage forms, Oral Liquids, Parenterals, Semi-Solids, Lotions, and Ointments.

Aseptic processing, and clean room/controlled environment manufacturing.

Terminal sterilization as well as sterile filtration.

Scale-up and technology transfer to commercial manufacturing.

Experience with Karl Fisher titrations for moisture determination, freezing point osmolality, HPLC, microscopy for particle sizing as well as using zetasizer.

Fully conversant with all analytical techniques employed in the characterization and quality of Drug Substances and Drug Products.

Microbiological and Immunological techniques, all forms of sterilization methods utilized in pharmaceutical manufacturing.

Experience in running animal studies, mice, guinea pigs, rabbits, pigs, avian.

Quality Systems, Change Control, and all relevant forms of documentation.

Process Analytical Technology and aspects of QBD to ensure a comprehensive Design Space for developed

products.

Batch Record preparation and documentation as well as SOP writing.

ICH guidelines Q8, Q9, Q10, cGMP, GXP, CFR Part 211 FDA guidelines, EMA guidelines.

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