Senior Manager; Product Development, Research & IP

PROFILE:

Highly motivated individual with strong leadership skills, having 15+ years’ international R&D leadership experience in the biotech industry with a proven ability in leading highly technical teams. Efficiently managed and launched +7 Class II/III bioactive products working to CFR and ISO quality system regulations, having an accumulative sales value of +$220 million. Strong communications skills, reflected by an ability in technical and scientific paper writing, technical presentation and patent generation in building a strong global presence in the commercial, clinical and scientific communities. Eligible and qualified to be granted a professional visa to work in the US.

PROFESSIONAL EXPERIENCE:

Senior Manager; Product Development, Research and IP 2008-present

Stryker ORTHOBIOLOGICS; Limerick, IRELAND/ Boston, USA

Stryker OrthoBiologics is a leading research and manufacturing of biotech based technologies for the regeneration and healing in patients suffering from bone, cartilage and soft tissue injuries and defects

Achievements;

• Technical lead in an divisional BD&L and M&A activity that was accretive in the first year resulting in a 100% increase in market share and increased growth of revenues by $95 million annually,

• Currently direct and manage an annual Product Development and R&D expense budget of $2.6 million,

• Experience in directing technology exploration, analysis and execution for growth opportunities to satisfy unmet customer needs within both existing market categories and also the creation and redefining of new categories for market growth,

• Managed Product Development program to gain further regulatory indication approval to deliver unmet customer needs that lead to a 120% increase in associated EU product sales,

• Directed project teams in the completion of multiple Stage Gate milestones and feasibility initiatives on divisional program portfolio in preparation for commercial launch,

• Managed Product Development of multiple line extension programs to support existing products,

• Establish and maintain key surgeon and regulatory representative relationships,

• Oversaw prosecution of some 16 patent applications in five countries with three outside legal firms, whilst personally authored and filed 8 PCT patent applications,

• Establishment of high value partnerships with international research and preclinical organizations in the development of driving collaborative programs,

• Sourced, identified (and member of audit team) multiple vendors including raw material suppliers, preclinical facilities and test laboratories,

• Represented Stryker in multiple Tradeshows, Clinical and Research Summit meetings including key technical lead in two successful divisional plant FDA audits,

• Finalist for Stryker’s R&D Awards for the category “Best New Product”,

• Award winner at Stryker’s Patent Society Dinner Awards for 5+ years for granted IP.

Research & Development Manager; Biomaterials 2005-2008

Stryker OSTEOSYNTHESIS, Freiburg, GERMANY

Stryker Osteosynthesis is a market leader in Trauma and Craniomaxillofacial products and services.

Achievements;

• Founded, set-up and managed a 15-person R&D and biotech manufacturing group,

• Controlled, planned and budgeted all necessary expenditure related to the biotech group (avg. yearly budget of $4+ million),

• Managed the transition and integration of next generation & 3 existing product lines to both internal and external manufacturing locations,

• Managed BD&L of outsourced products to enable distribution within Stryker’s customer base,

• Lead the development and launch of multiple product lines, e.g.;

o Delta Bioresorbable System™ resorbable plate & screw technology, [FDA 510(k) clearance no.; K993061], resulting in ~$4mill annual sales,

o Bioresorbable Flatfoot Implant™ [CE Mark only], having ~$2mill annual sales,

o HydroSet® [FDA 510(k) clearance no’s; K051603, K060061, K060750 and K060763], with ~$33mill associated annual sales,

• Lead the development effort for technology feasibility evaluations on the following technologies;

o Antibacterial and Osteoconductive coating technologies, and

o Next Generation composite bioresorbables.

• Delivered multiple presentations to prospective customers and participated in many international trade shows and exhibitions (NAAS, ORS, EFORT),

• Front room audit lead in one FDA plant audit and three CE Mark site audits,

• Winner for Stryker’s R&D Awards for the category “Best New Technology” and “Best Team Synergy”.

Senior Project Engineer; Biomaterials 2003-2005

Stryker ORTHOPAEDICS, Limerick, IRELAND

Stryker Orthopaedics is a global leader in the development, manufacture and sale of orthopaedic products and services.

Achievements;

• Lead the development effort and supported the launch of Calstrux™ Bone Void Filler, [FDA 510(k) clearance no.; K041421], with resultant ~$5mill annual sales,

• Provided manufacturing support to increase efficiencies in the production of calcium phosphate based products, resulting in increases of up to 300% in productivity output,

• Supervision of 2 postgraduate and 3 University based degree projects through Stryker funded studies,

• Publication of product based findings in 5 journal papers to support marketing and sales teams,

• Drafting and submission of two patent applications for Intellectual Property protection,

• Support of Marketing & Sales groups through provision of data to the field and Sales meetings support,

• Front room audit lead in one FDA plant audit and two CE Mark site audits.

Research Engineer; Biomaterials 1998-2003

Stryker ORTHOPAEDICS, Limerick, IRELAND

A global leader in the development, manufacture and sale of orthopaedic products and services.

Achievements;

• Team member in the development of multiple bioactive coatings and bone void fillers including;

o Peri-apatite® osteoconductive coating, [FDA 510(k) clearance no.; K971206], having ~$20mill associated annual sales,

o BoneSource® Classic and BoneSource® BVF Bone Cement, [FDA 510(k) clearance no’s; K021440 and K031435], with ~$12mill associated annual sales,

o RapidSet™ Bone Cement, [FDA 510(k) clearance no.; K032366], having ~$5mill associated annual sales.

• Successful scale-up and transfer of new processes and equipment from research based projects ready for transfer to manufacturing,

• Process optimisation and troubleshooting which required working closely with Manufacturing and Quality Departments in order to deliver more cost effective, safe and robust processes,

• Publication of product based findings in 5 journal papers to support marketing and sales teams,

• Drafting and submission of one patent applications for intellectual property protection.

Junior Research Engineer; Biomaterials 1997-1998

Pfizer HOWMEDICA, Limerick, IRELAND

A global leader in products for orthopaedic reconstruction, trauma repair and craniofacial surgery

Achievements;

• Development of multiple surface treatments processes for use in metallic and ceramic based biomaterials to increase their functional life-span,

• R&D team member in the validation of a wet chemical precipitation process of a bioactive calcium phosphate coating (Peri-apatite®),

• Sourcing and development of external product testing.

EDUCATION:

Doctorate in Philosophy (Ph.D.) 1998-2002

University of Limerick, IRELAND

Bachelor of Science: Materials Science (Honours Degree) 1994-1998

University of Limerick, IRELAND

PUBLICATIONS:

A list including public informative articles, patents (10), peer-reviewed publications (19) and numerous conference proceedings (27) that have been published is available upon request.

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