Medical R&D Manager

Galway

About Chanelle Pharma:

Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.

Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions. 

Building on over 35 years of research and development, with over 4,500 licenses registered worldwide, Chanelle Pharma is headquartered on an 18-acre campus in Loughrea, Co Galway, with three manufacturing facilities, four research and development laboratories and a fifth R&D laboratory in Jordan. The company employs 550 people in Ireland, UK, Jordan and India. At Chanelle Pharma our employees drive our success and you will have the opportunity to collaborate in our diverse and inclusive environment, the ability to learn and grow in your career, and an opportunity to make a direct impact on our business and customers. 

Chanelle Pharma has a proven track record of innovation and makes a significant investment in R&D annually and has doubled its sales growth in the last 5 years.

In 2018, the company announced an €85 million investment, the single largest investment by any Irish owned company, to double manufacturing capacity, launch 96 new products and grow its workforce to 850 people over a period of 5 years. As part of the investment, Chanelle opened a purpose built €10 million manufacturing facility in 2018 for the company’s expansion plans into the US market. The facility received FDA approval in September 2019.

Chanelle Pharma is on an ambitious growth trajectory and expanding its workforce across a number of disciplines in science, engineering, quality, finance, sales and marketing.  The company won 2018 Pharma Company of the Year and Industry Company of Year, the first indigenous Irish company to win the award.

 

The Opportunity:

This is an opportunity to be part of a dynamic team within the Medical R & D formulation function. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
In this role you will report into Head of R & D

KEY RESPONSIBILITIES:

Responsible for the formulation of Chanelle medical pipeline products and the running of the R&D pilot scale manufacturing area within a GMP manufacturing facility.
• The development and scale-up of solid dosage and liquid dosage formulations for the European and global markets.
• Assist in the transfer of R&D medical products into production
• Responsible for the placing of R&D orders to production, preparation of batch manufacturing and packaging records, R&D process validation protocols and reports stability protocols and reports and familiarity with Bill of Material.
• Interpretation of analytical results i.e. formulations is required.
• Preparation and approval of all Development and analytical reports for R&D medical products
• Comply with all the relevant regulatory guidelines for European and US FDA, ICH guidelines for development, analytical, process validation and stability studies.
• Overseeing process optimisation and process validation of medical R&D products.
• Familiarity with operation principles of standard manufacturing equipment used in solid oral dosage forms and liquid dosage forms and GMP principals required for scale up batches (including biostudy batches)
• Coordination with external formulation sites.
• People management: Managing and developing direct reports to include coaching, motivating and ensuring adequate training in order to meet and exceed individual and team goals.
• To drive efficiency and effectiveness within the medical R&D team and the processes employed in medical R&D area.
• Work with the medical regulatory team to respond to all Authority R&D questions as required.

COMPETENCIES:

Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication skills.
• The ability to plan and execute multiple development projects and to work in a busy development environment
• Sound knowledge of formulation development and tech transfer for the solid oral and liquid oral dosage forms in pharma companies in previous role/s.
• Sound knowledge on the regulatory requirements for EU/Canada/US/Australia and ROW
• Project management experience is essential
• Excellent written and communication skills.
• Experience in the formulation of medical oral solid dosage forms, liquids and modified released products etc. Post graduate qualifications in Pharmaceutical technology an advantage
• Demonstrate initiative in idea generation, experimental design and write reports with minimal consultation.
• A strong working knowledge of best practice processes, change management implementation.
• Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
• Ability to build relationships and collaborate with others is vital.
• Demonstrate and lead on the values, initiatives and culture of an organization. Professional expertise.
• Positive and proactive person who is energized by having great responsibility.

  • Practical, action-orientated approach to managing priorities and teams.
    • Strong computer skills in MS Office

QUALIFICATIONS:

Applicants will hold a Masters in pharmacy /PhD in pharmacy desirable
• Have 15+ years formulation development experience in the pharmaceutical industry with at least 3+ years in EU formulation developments
• Experience in the formulation of medical oral solid & liquid dosage forms.
• Experience working within a pharmaceutical cGLP Environment; with knowledge of EU GMP and US FDA Guidelines
• Demonstrate initiative in idea generation, experimental design and write reports with minimal consultation.
• Excellent written and communication skills.
• Strong computer skills in MS office.

Medical R&D Manager

Galway