Collins McNicholas currently have an exciting opportunity for a Manager – Biotech Production with one of their clients in the Mid-West Region. This role is a permanent position.
Summary: Oversees implementation of commercial & clinical manufacturing production schedules. Manages the manufacturing shift team in relation to process execution for Upstream/Midstream and/or Downstream processes
The following are the key requirements for the role:
- Manages commercial scale manufacturing of recombinant proteins according to approved protocols, regulation, and schedule.
- Manages a team responsible for the manufacture of bulk drug substance in a cGMP regulatory environment.
- Ensures that the highest safety and housekeeping standards are maintained.
- Builds strong teamwork and alliances with the other Shift Supervisors/Managers.
- Ability to train, develop and mentor direct reports and effectively manage the performance of individuals. Works closely with staff to develop and manage individual goals and objectives.
- Ensures that policies and procedures are effectively executed and that they comply with regulatory requirements.
- Tracks and trends relevant technical and business process metrics to ensure operations are performing effectively and efficiently.
- Ensures the effective use of material, equipment and personnel in producing quality products.
- Interfaces with other departments, such as Facilities, Process Development, Process Analytical Sciences, Regulatory, Quality Assurance and Quality Control.
- Provides technical input to resolve process problems.
- Leads and implements continuous improvement initiatives.
- Represents manufacturing during regulatory audit tours. Performs cGMP audits of production area.
- Participates in safety, process and environmental investigations. Reviews alert and action limits as needed and implements corrective action as appropriate.
- Requires a 3rd Level Qualification in Life Sciences with 7+ years of relevant experience in manufacturing within the Biopharma industry.
- Requires 5+ years supervisory experience.
- Knowledge of cGMP and ICH guidelines.
For a confidential discussion on the above role please contact Michael O’Leary on 061-512270