GMP Operations Manager

Highly Competitive
  1. Permanent
  2. Good Manufacturing Practice (GMP)
  3. United Kingdom
Stevenage, England
Posting date: 24 Sep 2019
QA.KB.25417_1569335771

An international biotechnology company is recruiting a GMC Operations Manager to their UK office. The organisation focuses on gene therapy to treat the suffering of people suffering from chronic systemic diseases. With a next-generation gene therapy platform to provide treatments for a wide range of diseases, this position represents an exciting opportunity to work with a leading company.

Job Responsibilities:

  • Working closely with the Dir. GMP Operations in the establishment and operation of company manufacturing capability within the CGT-MC for on-time delivery of Drug Substance for clinical supply.
  • Working 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.
  • Managing the production schedule, maintenance schedule and annual facility shutdowns.
  • Mapping out campaigns 12 months in advance to meet clinical supply demand across multiple programs.
  • Acting as 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.
  • Attending daily planning meetings, operations forums and steering meetings with CGT-MC.
  • Acting as team lead for safety in both internal and CGT-MC for a.
  • Coordinating and leading GMP Operations daily, weekly and steering meetings, setting agenda, capturing actions and tracking completion.
  • Maintaining accurate and up-to-date training matrix for all GMP Operations team personnel and auditing for compliance.
  • Onboarding new team members, coordinating training (company and CGT), and site induction.
  • 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.
  • 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.

Skills and Requirements:

  • Educated to degree level or equivalent in chemistry or a biological science.
  • 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.
  • Proven track record in project management for biotech/pharma development.
  • Experience leading cross-functional teams.
  • Demonstrable multitasking, project management, and execution skills.
  • Good interpersonal skills, including communication, presentation, persuasion, and influence.
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
  • Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Katty Maia at +44 2038543317 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

#LI-KB1

#Compliance/Quality

close