Process Development Manager
Permanent role
Location: Cambridgeshire
Salary: 75,000
Benefits: Personal Days, Private Medical Cover, Enhanced MAT/PAT Leave, Bonus & more
An exciting opportunity for an established Process Development Managerhas arisen to join a global leader in contract manufacturing for medical device, diagnostics, and drug delivery.
Overview:
- Provide leadership direction and coaching to staff.
- Lead development and improvement actions for manufacturing processes
- Creation of quotations for Process Development and Manufacturing work
- Development and validation of manufacturing processes in support for business development and IP generation via proprietary processes or techniques.
- Implementation of pharmaceutical and regulatory requirements for manufacturing processes.
- Set and manage objectives and KPIs for the process development team
- Supporting manufacturing teams with technical troubleshooting of fill-finish processes
Key Responsibilities:
- Manage Process Development in an efficient and effective manner through processes, systems, people and data to maximise output and delivery.
- Foster a culture of continuous improvement, behavioural safety and employee engagement through coaching, mentoring and development opportunities.
- Ensure health, safety and environmental compliance. Work with the teams to improve employee engagement in these initiatives.
- Set department and individual objectives, complete regular performance reviews and monitor ongoing progress and performance in a timely manner.
- Draft, write and review process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to cGMP manufacturing.
- Draft, write, and review technology transfer documentation for any processes being used for fill-finish.
- Collaboratively improve and/or troubleshoot manufacturing processes and proposeneeded protocols for data collections and/or experimentation.
- Implement and maintain robust quality management systems across process development to ensure compliance with regulatory requirements and customer expectations.
- Risk analysis of processes including prioritisation and implementation of mitigations
- To work collaboratively with Business Development and other technical colleagues, providingsupport relating to proposal / project development and direct customer engagement.
- Any other appropriate duties relevant to success of the company
- Occasional travel.
- Responsible for Health & Safety and wellbeing of self, staff and visitors by ensuring that the function operates in accordance with any health, safety and environmental policies and procedures
Background & Qualifications:
- BSc or MScin biology, pharmaceutical science, biotechnology, or biomanufacturing
- Experience working within cGMP fill-finish environments (ISO:13485 and Annex 1).
- Manage CMOs and suppliers in technical and project planning activities for process development, technology transfer and validation.
- Experience in managing a small team.
- Lead/Manage elements of technology transfer into cGMP production
- Experience in risk assessment and risk management