GMP Operations Manager

  • Freeline
  • Job type: Permanent
  • Closing by 15/11/2019
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Description

Freeline is a privately-held clinical-stage biotechnology company based in the UK and Germany. We have an ambitious vision to create better lives for people suffering from chronic systemic diseases using gene therapy as a one-off curative treatment. Freeline has a clear focus on gene therapy (AAV) targeting the liver with the aim to provide treatments for diseases with significant unmet patient needs.

Our gene therapy treatment builds upon the pioneering, world renowned work by the Freeline CSO, Professor Amit Nathwani. His award winning scientific work has already been life changing for patients with Haemophilia B by making gene therapy safe, effective and reliable.

Innovation and entrepreneurial spirit is at our core, but our passion is working together as one team and tangibly making life changing impact. We are therefore looking for talented and passionate professionals who are driven and team orientated. If you share our vision for excellence and are looking for a high paced work environment you may be a great fit for our team.

Role and responsibilities 

To work closely with the Dir. GMP Operations in the establishment and operation of Freeline manufacturing capability within the CGT-MC for on-time delivery of Drug Substance for clinical supply

Work closely with the Dir. GMP Operations in planning for and establishing new GMP facilities. Manage the project plan and work as part of a multi-disciplinary matrix team to drive on-time delivery

To manage the production schedule, maintenance schedule and annual facility shutdowns

Mapping out campaigns 12 months in advance to meet clinical supply demand across multiple programs

Be the GMP Operations team primary point of contact with CGT-MC for scheduling activities in the facility including material / waste transfer, equipment transfer, equipment maintenance, qualification activities etc

Attend daily planning meetings, operations forums and steering meetings with CGT-MC

Team lead for safety in both internal and CGT-MC fora

Coordinate and lead Freeline GMP Operations daily, weekly and steering meetings, setting agenda, capturing actions and tracking completion

Be responsible for maintaining accurate and up-to-date training matrix for all GMP Operations team personnel and auditing for compliance

Be responsible for onboarding new team members, coordinating training (Freeline and CGT), and site induction

Be responsible for tracking open GMP Operations deviations, change controls, corrective and preventative quality and safety actions. Providing weekly status updates to GMP Operations team, ensuring actions are closed on time

To be a key senior team member working closely with technical managers and supply chain managers in GMP Operations, QA, QC and equivalent functions within CGT-MC able to work effectively as senior matrix team member representing Freeline

Represent Freeline in regulatory inspections

Qualifications, education and experience

Education: 

Educated to degree level or equivalent in chemistry or a biological science.

Experience:

Operations experience preferably in a manufacturing setting with experience of development of systems and processes to enable both team operation and facility operation

Experience of working in a continuous improvement environment / implementing lean methodologies

Excellent verbal and written communication and computer literacy skills

Strong project planning skills with familiarity with MS project and typical Project Management tools

Proven track record in project management for biotech / pharma development

Experience leading cross-functional teams

Demonstrates strong analytical and problem-solving skills

Other:

Fluent in English

Line / matrix management experience

Excellent verbal and written communication and computer literacy skills

Excellent interpersonal and facilitation skills

Ability to work well autonomously and within a multi-disciplinary team environment

Effective time management

Job type

Permanent, full time

Location

Stevenage, UK

Apply now

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