Merrion Pharmaceuticals plc, an international pharmaceutical product development company, announced today its preliminary financial results for the year ended 31 December 2010.

Operating highlights

• During November and December 2010, Merrion signed a number of feasibility and option agreements which significantly expanded the Company's partnered pipeline by an additional six compounds. The deals signed were as follows:
• On 21 December 2010, Merrion signed a collaboration and option agreement and warrant agreement with Novo Nordisk A/S, a world leader in diabetes medicine. Under this agreement, Merrion will evaluate the ability of the GIPET technology to boost the oral bioavailability of an undisclosed proprietary compound. Following the feasibility studies, Novo Nordisk will have the option to enter into a further licensing agreement for Merrion's GIPET technology on agreed terms. As part of the agreement Merrion has granted Novo Nordisk a warrant to acquire ordinary shares of up to €1,500,000 in Merrion at an agreed price following the signing of a license agreement. Merrion can also require Novo Nordisk to acquire up to €500,000 worth of shares in Merrion at the same agreed price following the signing of a license agreement.
• In November 2010, Merrion entered into a feasibility and option agreement with Rebel Pharmaceuticals LLC on two undisclosed compounds whereby Merrion will evaluate the ability of its patented GIPET technology to enhance the compounds' clinical profile and create a substantially improved product. Key license terms have been agreed, should the programmes progress to license.
• In December 2010, we signed a feasibility and option agreement for three compounds with an international 'top ten' pharmaceutical company. The agreement will evaluate the ability of Merrion's patented GIPET technology to boost the bioavailability of three of the 'big pharma' company's compounds.
• In November 2010, Merrion finalised a Phase III development programme for Orazol™ under Rule 505b (2) with the Food and Drug Administration (FDA) in the USA. The study will compare Orazol against placebo as an adjuvant breast cancer treatment (a new indication for zoledronic acid) with a primary endpoint of disease free survival of patients with breast cancer. Previous (third party) large scale studies of zoledronic acid have shown its benefits in reducing breast cancer recurrence and death. The Company had previously agreed its Phase III trial design with the European Committee for Medicinal Products for Human Use (CHMP) for Orazol in Europe for bone metastases. It is the Company's intention to license Orazol to a partner to complete trials and file for registration.
• The Company continues to work with Novo Nordisk on its oral insulin and oral GLP1 product. Novo Nordisk has commenced Phase I clinical trials for oral GLP-1 and oral insulin analogues using Merrion's GIPET technology. The Company expects these clinical trials to continue through 2011.
• During the year, Merrion was issued two important US GIPET patents covering the GIPET technology and our Orazol product.
• In July 2010, our new 30,000 sq.ft. state of the art facility in Citywest was granted a license under the EU Clinical Directive for Investigational Medicinal Products, allowing Merrion to manufacture for clinical trials.
• In addition, during the year, several feasibility studies were conducted on potential new products, new technology development programmes were initiated and Dr. Hing Kin Chan was appointed as Chief Business Officer.

Gerry Kennedy : 01 2302400: gerry(at)rftgroup.ie : www.rftgroup.ie

Health Outcomes Manager
 
Our client is a major multinational blue chip pharmaceutical manufacturer. Based on a fixed term contract at their national headquarters in Dublin the newly appointed Health Outcomes Manager will report to the Launch Director  and will be responsible for leading  the health outcomes team in the generation of high quality and timely data to support the launch and continued access of brands for Ireland.

They will also take the lead role in evaluating and managing the early pipeline products for the company in Ireland. They will ensure the market access hurdles and the size of the commercial opportunity is understood and communicated to senior leadership and that launch excellence for these early assets is effectively delivered. 
 
ACCOUNTABILITY: 
 
Development & management of the Health Outcomes Team
·     Lead the development, management and implementation of health outcomes strategies to support the launch and commercial objectives of products in collaboration with colleagues in the launch directorate
·     Identify and coordinate local epidemiological and studies with health outcomes component
·     Develop and/or modify cost effectiveness and budget impact models to support the delivery of the business objectives (e.g. market assess/formulary listing and promotion )for vaccines and commercialized brands
·     Manage relationships with the National Centre for Pharmacoeconomics, the Health Information & quality Authority, the Department of Health & the Health Service Executive on pricing & reimbursement issues.
·     Represent the company in Ireland on the N&W Health Outcomes and other relevant networks

 
New product introductions:
·     For early pipeline assets be the lead source of knowledge for Ireland and, drawing on support from Decision Support function, retain an oversight to ensure that appropriate progress is made in delivering commercialization of these early assets prior to allocation of dedicated cross functional resource to the assets.
·     To coordinate and support the interface with horizon scanning agencies within Ireland to ensure appropriate and timely information on the pipeline is provided in collaboration with medical colleagues.
·     Establish strong collaborative links with relevant Centres of Excellence for the various early pipeline assets and maximize Ireland’s participation in European Advisory Boards, CRTs, and costing studies as these early plans evolve.
·     Establish and chair a periodic Future Portfolio Team meeting to drive senior management engagement with early pipeline assets and allow a future view be formed both of commercial potential and resourcing requirements in a 2yr plus horizon.

 
Developing people:
Provide a mentoring role to the Health Outcomes Specialists to develop their technical skills and capabilities.

 
 
COMPLEXITY: 
 

·     In-depth understanding of the company’s portfolio of medicines & vaccines.

·     Ability to understand the rapidly changing external prescribing/payer environment within Ireland.

·     Ability to adapt quickly to changing market place and business climate to ensure identification of markets and business opportunities for a number of early pipeline assets.

·     Ability to network effectively, internally and externally to develop productive working relationships with key stakeholders.

·     Ability to work with senior leaders across the business without line-management authority.

·     Works closely with European HO and market access colleagues to share best practice.

SPECIALISED KNOWLEDGE:
 

·     Graduate degree in economics, health economics or health services research.

·     Experience of working in the health sector would be considered an advantage.

·     Must have a broad understanding of the Irish healthcare system and specifically the Health Technology Assessment process.

·     Strong economic modelling skills with academic or practical experience.

·     Strong written and verbal communication skills with an ability to work in collaboration with others.

·     Strong team working and inter-personal skills

·     Must have the ability to lead a HIQA/NCPE submission process for relevant products.

·     Must have the ability to plan/implement projects that are appropriate and realistic and to deliver results within agreed timeframes.

·     Must have the ability to successfully manage multiple projects.

·     Ability to build and sustain relationships internally and externally.

·     The ability to influence internal and external customers on issues that are new and potentially controversial

Please contact Gerry Kennedy, on 01 2302400 or email your CV to gerry(at)rftgroup.ie,

All applications will be held in strict confidence. Please call me if you have any further queries.

Operations Manager

Our client is a leading global player in the development and manufacture of biotechnology based products and services designed to enable researchers to accelerate scientific exploration, driving to discoveries and developments that improve the human condition and the world around us.
Our clients customers do their work across the biological spectrum, working to advance personalized medicine, regenerative science, molecular diagnostics, agricultural and environmental research, and 21st century forensics.

With historical sales of approximately $3.5 billion, a presence in more than 100 countries, and a rapidly growing intellectual property estate of over 3,600 patents and exclusive licenses, our clients are poised to truly shape the world of science. Employing 9,500 employees around the world who are engaged, curious, insightful, responsible and driven to make life even better.  
   
Main Position Objectives:  This newly created role reports to: Head of local business entity (solid line) and Head of Instrument Manufacturing
The management, co-ordination and planning of design for manufacturing, manufacturing pilot (including custom elements), and transfer to mainstream manufacturing. 
Management and oversight of related functions/activities, e.g. Quality, EHS, Project Management, Productivity and Facilities.

Responsibilities:
Collaborates with R&D to ensure design for manufacturing, and prepares effective pilot manufacturing activities and manufacturing transfer. These activities should include developing strategies and tactics for the introduction of required capabilities and infrastructure for the development and production of products, ensuring adequate documentation, training and validation of new processes, parts and methods/SOPs.
Management and oversight of local operational functions, e.g. EHS, Quality, Facilities, etc., ensuring compliance with required local regulations and company policies.
Ensures appropriate focus on Continuous Improvement targets to meet and/or exceed ongoing Cost, Quality, Availability and Safety objectives. Results in increased profitability and added value.
Participates in personal development programmes to further enhance skills and knowledge relevant to the position. Additionally, promotes and implements staff training, motivation and personal development.  

Interfaces with Others
Local entity management, R&D colleagues (local and cross site), manufacturing personnel Operations management.
Direct and indirect reports, including Mfg, Quality, HR, EHS, & Finance colleagues 

Education, Knowledge & Business Expertise. Language and Computer Skills:
First and/or Second Degree level in an appropriate science discipline and/or relevant industrial experience.
Excellent commercial and financial awareness and a thorough understanding of Company operations.
Excellent leadership and people-development skills.
Experience of operations in a foreign country preferable.
Practical knowledge of Continuous Improvement approaches (e.g. Lean Enterprise and 6-Sigma), and their implementation desirable.
Extensive management experience, to Senior Manager level, in a high technology Development and/or Operations role, which would preferably include experience in instrument and reagent development and manufacturing.
Ability to lead and develop a group of broadly based technical staff up to PhD level.
5 years + experience

 
CV to gerry(at)rftgroup.ie     Recruitment for Technology Ltd     00 353 1 2302400    www.rftgroup.ie 

 

Lean Sigma Manufacturing Engineer - Pharma - Ireland
Responsibilities
Impart Lean training to colleagues.
          Method 4
          Lean Leadership Awareness
          Associated Lean tools (e.g., 5S, Standard Work, SMED, Poka Yoke, Cell manufacturing, Kaizen events)

Coach and mentor Lean GB and Lean BB upon completion of projects.
Approve Lean GB and BB projects.
Execute high impact Lean projects.
Develop, maintain and review lean training materials.
Support product End to End projects to map current products lead time and identify improvement opportunities including projects at each individual site. Work with sites to identify waste within their value stream.
Develop roadmap on how to reach the strategic goals for the extended value stream.
Identify improvement opportunities at the interfaces between sites.
Work with Supply Chain Management to align flow of product through the value stream with customer demands.
Provides guidance in prioritizing the areas of opportunities and support the project selection process.
Perform assessments to evaluate Lean readiness and site stage of development.
Develop business unit Lean deployment strategy.
Liaison with other Lean Deployment Leaders to ensure alignment of the Lean program global standards.
Work closely with site RFT colleagues to provide strategic advice to sites on Lean deployment and utilization.
Maintain a business unit Lean colleagues' capabilities record.
Responsible to develop next generation of Lean Masters.
Support site transformation projects including:
Coaching and guiding plants from the Diagnostic to the Implementation phases of a full site transformation cycle.
Aiding plants in identification of highest value areas for improvement and supports diagnostic of plant performance with site improvement teams and operators to confirm opportunities.
Finalising project charters, developing project plans, mobilizing site resources.
Supporting performance/culture diagnostic, identification, quantification and prioritization of improvements by effort / value.
Supporting plant teams to establish pilots, refine solutions / targets, design implementation plans, and identifying needed changes to mindset and capabilities.
Designing continuous improvement process and trains up colleagues for sustainability. 

Qualifications:
BS degree in a technical discipline.
Relevant years experience in the pharmaceutical manufacturing environment.
Relevant years experience in a manufacturing and / or quality role.
Demonstrated teaching and coaching skills.
Proven negotiation and influencing skills.
Demonstrated problem-solving abilities.
Minimum certified Green Belt. Black Belt. or Lean Master preferred.
Other Information - Internal
Experience in a leadership role.
Adapt to work priorities in response to complex or rapidly changing environment.
Operate in a multicultural environment.
Deliver results with limited resources.
Develop and execute strategies with minimum guidance.
There is a significant amount of travel with this role. 

Please contact Laurentina Kennedy, on 01 2302400 or email your CV to laurentina@rftgroup.ie, Skype: rftgroup-laurentina-kennedy.

All applications will be held in strict confidence. Please call me if you have any further queries.