Pharmaceutical Product Lifecyle Lead - Dun Laoghaire
Julie at CK Group is recruiting for a Pharmaceutical Product Lifecycle Lead to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 12 month contract basis.
The Company: Our client is one of the worlds leading manufacturers of biosimilar and biopharmaceutical products used in the treatment of a wide range of human healthcare conditions from cancer to arthritis. This company are a strong believer in helping patients by developing new treatments and taking them to market via their global network of specialist aseptic manufacturing, packaging and distribution sites.
The Location: This role is located on a state of the art manufacturing facility based in Dun Laoghaire and is a quick 30 minute drive away from the centre of Dublin, or 60 minutes drive from Dublin Airport. The site is easily commutable from Kildare or Wicklow by car and there is a good public transport network if you would prefer to live within Dublin itself. Dun Laoghaire is a vibrant cultural hub in south Dublin which is best known for its maritime history and locally caught sea food.
- Product Health Steward.
- Manage and develop site product lifecycle (multiple products).
- Assist in developing long term site product vision and strategy.
- Serve as main point of contact for global operations leads (GOLs) & PDT's.
- Ensure that site product needs are presented and prioritised appropriately at site and global level.
- Own product health for the site through product governance: capacity, changes, risks.
- Serve as main point of contact for global operations leads and ensure that site product needs are presented and prioritised appropriately at global level.
- Build and manage the relationship with the product & process knowledge SMEs at network and site level.
- Develop site product risks and implements plans to remediate risks.
- Makes critical decisions and provide Process Transfer Technical Leadership on the cross-functional Tech Transfer/NPI project team & at Technology Development and Transfer Governance Forums.
- Attendance at above site product governance meetings i.e. Product Review meeting, Site Ops meeting.
- Ensure changes to global product roadmap and contract books are fed back to site through Product governance and prioritised appropriately.
- Ability to influence key stakeholders on site and above site; Protecting site strategy while meeting network demands.
- Long range vision of product.
- Ability to prioritise complex projects.
- Support new product/market launch.
- Basic Qualifications.
- Technical Degree and/or Masters or equivalent.
- A strong working technical knowledge in a range of products and their associated manufacturing sciences, technologies and analytical processes from within parenteral fill-finish, or oral dosage forms and/or packaging is required.
- Strategic understanding of Product Lifecycle management.
- Ability to identify gaps/risks and put appropriate remediation plans in place.
- A proven track record in the ability to transfer goals and objectives into measurable plans.
- Strong process and manufacturing background.
- Strong understanding of current GMP regulations and industry practices & trends.
- Excellent Communication Skills - continually communicating with peers and to stakeholders both internally and globally.
- Ability to work independently.
For more information or to apply for this position, please contact Julie on 01438 723500 or email firstname.lastname@example.org. Alternatively, please click on the link below to apply online now. Please note that your CV should show exact dates of employment (month and year) and any gaps of a month or more should be explained.
CK Group is an Equal Opportunities employer and welcomes applications from all who meet our selection criteria.
If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment campaign. Entitlement to work in the EEA is essential. Please quote reference 45196 in all correspondence.