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Process Development Manager

Adepto Technical Recruitment Ltd
Posted 17 days ago, valid for 6 days
Location

Cambridge, Cambridgeshire CB21NT, England

Salary

£75,000 - £80,000 per annum

Contract type

Full Time

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Sonic Summary

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  • The role of Process Development Manager is a permanent position located in Cambridgeshire with a salary of £75,000.
  • Candidates should have a background in biology, pharmaceutical science, biotechnology, or biomanufacturing, along with experience in cGMP fill-finish environments.
  • The position requires leadership skills to manage and coach a small team, as well as experience in technology transfer and risk management.
  • Key responsibilities include overseeing process development, ensuring compliance with health and safety standards, and implementing quality management systems.
  • The role also involves occasional travel and offers benefits such as personal days, private medical cover, and enhanced maternity/paternity leave.

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

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