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 Operations Manager, this position is responsible for representing operations on NPI tech transfer teams, manufacturing readiness for the NPI and supporting first line trouble-shooting of the day to day activities within Operations. These activities include but are not confined to:
· Represent Operations on cross functional project implementation teams
· Monitoring and troubleshooting of the manufacturing process and equipment issues and process optimization
· Monitoring and reporting of process performance using statistical process control
· Investigating and resolving issues raised within the Manufacturing Department
· Participate in/ Lead Cross Functional teams when required
· Support of Commissioning and Qualification activities
· Preparation and updating of Batch Records, Standard Operating Procedures and Work Instructions
· Provide process and equipment related training as required within the Manufacturing Department
· Completion of assigned tasks to support manufacture of quality biomedicines in accordance with cGMP and EHS requirements.
· Managing QI (Quality Investigations).
General scope of responsibilities:
- Lead by example and strive to perform to high standards at all times
- 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.
- Carry out routine and non-routine tasks delegated by the USP MPS Lead according to appropriate procedures, values and standards.
- Carry out all activities in compliance with corporate and cGMP/EHS regulatory requirements.
- Compliance with Manufacturing and general site procedures at all times.
- Completion of all documentation in compliance with site procedures and GDP.
- Execution of activities as necessary to meet operational and business needs.
- Lead, support and participate in commissioning and qualification activities both current and future projects (and annual re-qualification activities). Also support to validation activities.
- Prioritize and schedule activities to support business needs and to meet requirements of Master Production Schedule.
- Lead and Support investigation and resolution of problems on plant.
- Participate in and lead Cross-Functional teams as necessary.
- Generate and assist with generation, review and revision of Manufacturing documentation as necessary.
- Ensure that personal training requirements are completed in compliance with site procedures. Training and support for new recruits to the Manufacturing group
- Support ongoing studies by Validation, OTS and other support functions.
Leadership responsibilities/ individual contribution:
· Report to USP MPS Lead.
· Represent Operations on cross functional project teams
· Be familiar with daily activities in Manufacturing
· Facilitate an environment of continuous improvement
· Facilitate an environment of open communication
· Lead investigations in work area as necessary.
· Lead Cross-Functional teams as necessary to support site goals.
· Support training of other Manufacturing colleagues.
- Collaboration and teamwork.
- Initiative and motivation.
- Share ideas and suggestions for improvement and encourage others to do the same.
- Demonstrate Credo value of integrity
· A relevant third level qualification in either Microbiology, Biochemistry, Pharmacy, Biotechnology, Science or Engineering
· Manufacturing experience within a GMP regulated environment.
· Experience of the cell culture or purification processes
· Project / New equipment installation experience
· Process engineering experience
· Commissioning and qualification experience
· Postgraduate Qualification.
· Experience of Microsoft Word, Excel and Outlook.
Key competencies required:
- Excellent interpersonal skills.
- Ability to operate as part of a team is critical.
- Customer focus.
- Mechanical/Technical aptitude.
- Excellent communication skills both written and verbal.
- Attention to detail.
- Good problem solving skills.
- Results and performance driven.
- Adaptable and flexible.