The employee is acquainted with the annual company and division goals and is aware of how he/she can influence these through his/her performance.
Essential Job Duties and Responsibilities
Reporting to Digital & Technology Lead, this position is responsible for leading the implementation of digital and technology projects within the Clinical Manufacturing team.
· Lead the introduction of MES to our Clinical Manufacturing facility
· Lead or support cross-functional for the deployment of new technologies within the Clinical Manufacturing facility
· Assess implementation requirements to prepare implementation plan and budgetary requirements for new technology projects
· Prepare budget requirements and develop business cases where needed
· Ensure knowledge is successfully captured
- Provide appropriate documentation and trainings for introduced technologies
General scope of responsibilities:
- Contribute to ideation and identification of technologies to onboard
- Lead by example and strive to perform to high standards at all times
- Carry out routine and non-routine tasks delegated by the D&T Lead according to appropriate procedures, values and standards.
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
- Responsible and accountable for assuring the safe accomplishment of job activities, following good environmental practices and procedures. Commit to and demonstrate safe behavior in every activity.
Leadership responsibilities/ individual contribution:
· Project Management skills
· Change Management skills
· Facilitate an environment of continuous improvement
· Facilitate an environment open communication
· Collaboration and teamwork.
- Initiative and motivation.
- Demonstrate Credo value of integrity
· Minimum of 4+ years of experience working in pharmaceutical development and/or manufacturing operations across drug substance and/or drug product.
· A relevant third level qualification in either Pharmacy, Biotechnology, Science or Engineering
· Knowledge of cGMP’s and Agency requirements for biopharmaceutical manufacturing is required.
· Experience with managing projects
· Manufacturing experience within a GMP regulated environment.
· Process engineering experience
Key competencies required:
- Excellent interpersonal skills.
- Ability to operate as part of a team is critical.
- Customer focus.
- Technical aptitude.
- Excellent communication skills both written and verbal.
- Attention to detail.
- Good problem solving skills.
- Results and performance driven.
- Adaptable and flexible.