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:

• 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 propose needed 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, providing support 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 MSc in 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