Adepto Technical Recruitment Ltd
Process Development Manager
Job Location
Pampisford, United Kingdom
Job Description
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
Location: Pampisford, GB
Posted Date: 12/25/2024
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
Location: Pampisford, GB
Posted Date: 12/25/2024
Contact Information
| Contact | Human Resources Adepto Technical Recruitment Ltd |
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