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 Manager has arisen to join a global leader in contract manufacturing for medical device, diagnostics, and drug delivery.
Overview:
1. Provide leadership direction and coaching to staff.
2. Lead development and improvement actions for manufacturing processes.
3. Creation of quotations for Process Development and Manufacturing work.
4. Development and validation of manufacturing processes in support for business development and IP generation via proprietary processes or techniques.
5. Implementation of pharmaceutical and regulatory requirements for manufacturing processes.
6. Set and manage objectives and KPIs for the process development team.
7. Supporting manufacturing teams with technical troubleshooting of fill-finish processes.
Key Responsibilities:
1. Manage Process Development in an efficient and effective manner through processes, systems, people and data to maximise output and delivery.
2. Foster a culture of continuous improvement, behavioural safety and employee engagement through coaching, mentoring and development opportunities.
3. Ensure health, safety and environmental compliance. Work with the teams to improve employee engagement in these initiatives.
4. Set department and individual objectives, complete regular performance reviews and monitor ongoing progress and performance in a timely manner.
5. Draft, write and review process descriptions, equipment SOPs, process change controls, process risk assessments, batch manufacturing records and other documentation relevant to cGMP manufacturing.
6. Draft, write, and review technology transfer documentation for any processes being used for fill-finish.
7. Collaboratively improve and/or troubleshoot manufacturing processes and propose needed protocols for data collections and/or experimentation.
8. Implement and maintain robust quality management systems across process development to ensure compliance with regulatory requirements and customer expectations.
9. Risk analysis of processes including prioritisation and implementation of mitigations.
10. To work collaboratively with Business Development and other technical colleagues, providing support relating to proposal/project development and direct customer engagement.
11. Any other appropriate duties relevant to success of the company.
12. Occasional travel.
13. 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:
1. BSc or MSc in biology, pharmaceutical science, biotechnology, or biomanufacturing.
2. Experience working within cGMP fill-finish environments (ISO:13485 and Annex 1).
3. Manage CMOs and suppliers in technical and project planning activities for process development, technology transfer and validation.
4. Experience in managing a small team.
5. Lead/Manage elements of technology transfer into cGMP production.
6. Experience in risk assessment and risk management.
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