The successful candidate will be a key member of the downstream management team. Responsible for all facets of downstream commercial and clinical scale production of the site.
This managerial role is an exciting new position in a state of the art facility in Limerick. There will be 3 or 4 direct reports associated with this role which will be a dynamic, fast paced and rewarding opportunity for the successful applicant.
Repsonsibilities include (but not limited to):
- Managing downstream commercial & clinical scale manufacturing according to approved protocols, regulation, and schedule.
- Provides technical input to resolve process problems and complex compliance issues.
- Communicate with Supervisors/Managers regarding technical, compliance & production process related issues
- Implements new production processes transferred by the MSAT/PMPD teams
- Performs cGMP audits of production area.
- Represents manufacturing during regulatory audits.
- Ensures that safety standards are maintained. Supports departmental safety projects.
- Performs personnel management functions including scheduling of holidays, personnel development, and performance evaluations.
- Works closely with HR to ensure teams are managed adequately.
- Works closely with staff to develop and manage individual and team goals and objectives.
- Interfaces with other departments, such as Facilities, Engineering, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
- Formulates and recommends manufacturing policies, schedules, procedures and programs.
- Develop high level Schedules, detailed production plans, and material requirements.
- Coordinate and helps manage validation activities involving Manufacturing equipment and processes.
- Reviews, and/or approves Standard Operating Procedures, specifications, regulatory filing, or other controlled documents as needed.
- Leads and implements continuous improvement initiatives.
We are looking for candiates with 12+ YEARS experience in a Downstream environment as well as a proven ability to lead people. Other requirements include:
- Excellent interpersonal, written, and oral communication skills;
- Substantial knowledge of cGMP's and experience in engaging with regulatory authorities.
- Self-aware, self-motivated, self-confident individual who is comfortable operating with minimal direction and who thrives in a dynamic environment
- Able to engender trust and respect quickly as a manager of people, with a priority for the development of staff.
If you would like to discuss this role please feel free to contact me for a confidential conversation.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.