GMP Process Lead

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Job Details

Location
Darlington, England
Salary
£32,000 - £42,400 per annum dependant on experience
Employment
Full-time - Permanent
Team
Operations
Deadline
30 Oct 2021 - 23:30
Reference
CPI-3082-21
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About CPI

At CPI we work with our partners to translate inventions into products and processes that enhance health and well-being, protect and improve our environment and increase productivity across industries.

With a deep understanding of innovation processes and funding, outstanding technical expertise and industry relevant assets, we enable products and processes to be quickly and cost-effectively brought to market. This supports the development of next-generation manufacturing, highly-skilled jobs and economic growth for the UK.

Our partners operate across many diverse markets including pharmaceuticals, speciality chemicals, food and drink, electronics and transportation.

Why this role is important for CPI’s work

CPI has an opportunity for an experienced GMP Process Lead to join us at the new RNA Centre of Excellence and training academy, based in Darlington, The centre supports the development, scale-up and manufacture of new and novel RNA therapies and vaccines. 

Read about the RNA Centre of Excellence here

The Process Lead will support cGMP manufacturing and participate with all cGMP production manufacturing operations on site. The role is to oversee and coordinate the daily activities, ensuring cleaning, environmental monitoring and maintenance schedules are up to date and maintained to GMP standards. Working alongside the GMP Facilities Lead. With a focus on the technical transfer of development projects into GMP manufacturers. Generating the relevant SOP’s and reviewing validation documentation for new and existing manufacturing processes. 

They will contribute extensively to development and improvement activities, identifying, and addressing future needs of the team to deliver on area strategy. As well as ensuring the required quality and safety standards are achieved and maintained with respect to cGMP operating procedures, all cGMP batch manufacturing documentation, area housekeeping in cGMP suites, SHE (Safety, Health & Environment), ensuring compliance with regulatory (MHRA Orange Guide etc) and legislative requirements.

Key responsibilities:

Accountable for ensuring procedures across the GMP shared areas are compliant and tailored to business and collaborator needs.

Generate, review, and approve GMP documentation such as Standard Operating Procedures, non-conformance reports, Out of specification results, review of Validation procedures.

Act as a point of contact for team members’ queries and escalations with regards to any Tech transfer project and or facility/​equipment issues within the GMP areas. 

The person we are seeking

Will have experience of Tech transfer — in the Pharmaceutical Manufacturing Industry, with experience within GMP environment.

Educated to HNC or Foundation Degree level (or equivalent) in a Scientific/​Engineering discipline plus significant industrial experience at a senior level 

Proven experience in Biologics or Pharmaceutical manufacturing.

Will have experience working within a GMP, Cleanroom environment and capable of generating, reviewing, and approving GMP documentation such as Standard Operating Procedures, Batch records, cleaning schedules, non-conformance reports and out of specification results

Desirable

Tech Transfer Background

What does CPI offer you?

At CPI, we offer a wide range of benefits to our employees, this includes:

  • Up to 33 days holiday, including bank holidays – Plus a holiday purchasing scheme
  • Generous pension scheme
  • Life assurance and accident insurance schemes
  • Flexible working
  • Learning and Development Opportunities
  • Free parking

Find out more about our culture and benefits.

Additional information

CPI is an organisation based in the UK. Commencement of employment is conditional to demonstrating right to work in the UK, sponsorship may be available.

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