CK Group is recruiting for a Process Development Manager to join a company in the Pharmaceutical industry at their site based in Dun Laoghaire on a 6 month contract basis.
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.
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.
The Process Development Manager you will manage and develop site product lifecycle and assist in developing the long term site product vision and strategy.
Key Responsibilities include:
· Serves as main point of contact for global operations leads
· Ensures that site product needs are presented and prioritized appropriately at site and global level
· Owns product health for the site through product governance: capacity, changes, risks
· Serves as main point of contact for global operations leads and ensures that site product needs are presented and prioritised appropriately at global level
· Builds and manages the relationship with the product & process knowledge SMEs at network and site level
· Develops site product risks and implements plans to remediate risks
· Ensures changes to global product roadmap and contract books are fed back to site through Product governance and prioritized appropriately
· Ensure compliance to cGMP at all times
To succeed in this role you will have extensive working experience in a similar role within the pharmaceutical or biotech industry. You will also have a working technical knowledge in a range of products and their associated manufacturing sciences, technologies and analytical processes from within fill-finish, or oral dosage forms and/or packaging. You will come from a strong manufacturing background and have an excellent understanding of GMP regulations and industry practices & trends and development, technical, manufacturing, validation, quality and regulatory processes.
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 45429 in all correspondence.
You MUST be eligible to work in Munster. Learn more
- Agency: CK Group
- Contact: Natasha Young
- Phone: 01246 457722
- Reference: 45429
- Posted: 2nd May 2019
- Expires: 30th May 2019