Senior CPD Technologist

at  Ipsen Manufacturing Ireland Ltd

Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company focused on innovation and specialty care.
We aim to make a sustainable difference by significantly improving patients’ health and quality of life and providing them with effective therapeutic solutions for unmet medical needs through differentiated and innovative medicines in Oncology, Neurosciences and Rare Diseases.
The patient is at the heart of everything we do, and we also care for our employees because they are the ambassadors who truly make the difference. We attract and develop bold, agile, entrepreneurial individuals who take full ownership of their decisions; leaders drawn by a purpose to make a direct impact through their work in people’s lives.
We offer employees a wealth of fulfilling challenges & growth opportunities, and the chance to contribute within a fast-moving organisation, an organisation that is genuinely game-changing.

SUMMARY:

Within the framework of Ipsen’s global Research and Development plans, and all relevant regulatory and EHS requirements, to develop, implement, scale-up and document manufacturing processes for new and existing API’s.

EDUCATION / CERTIFICATIONS:

• BSc or equivalent in Organic Chemistry or other relevant qualification.

EXPERIENCE:

• At least 2 years relevant pharmaceutical drug development experience in a process development role
  or minimum of 1 year experience in GMP environment.

MAIN RESPONSIBILITIES:

• Execute small-scale studies to develop and implement manufacturing routes for APIs. Provide synthetic

chemistry expertise in order to support development and scale-up of manufacturing routes for APIs.

• Produce batches of API to the required timeline, quantity and quality in support of preclinical and

clinical activities.

• Write and maintain SOPs relating to the group activities (API manufacture, equipment use and

maintenance etc.)

• Generate the necessary data and reports to support clinical trial application submissions for APIs.
• Record all work and maintain documentation to the required standard.
• Ensure the timely purchase of supplies where and when necessary to facilitate execution of various

process development and supply activities to plan.

• Carry out maintenance and calibration of equipment as required. Assist in sourcing equipment and in

its installation / commissioning as necessary.

• Knowledge of cGMP and adherence to IMIL site policies
• Ensure all CPD activities comply with local and group health and safety policies.

EHS RESPONSIBILITIES:

• Ensure Compliance with site EHS systems and procedures e.g. use of PPE, Permit to work Systems,

Incident/Accident Investigation procedures etc.

• Responsible for ensuring high standards of housekeeping are maintained within their area of work.
• Responsible for participation and active contribution to the departmental Risk Assessment Programme

as directed by their supervisor / department manager.

• Responsible for ensuring that all accident / incidents / near misses are reported to their area supervisor

/ department manager within a timely manner and contribution to subsequent investigations / reports.

• Responsible for contributing to the closure of EHS actions raised from accidents / incidents, audits, risk

assessments etc.

• Responsible for their respective attendance to scheduled EHS training modules as defined by the site

training calendar.

• Responsible for contributing to the departmental Continuous Improvement Programme as it pertains

to EHS/GMP on site