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Manufacturing Manager

RoslinCT
Job LocationEdinburgh
EducationNot Mentioned
SalaryCompetitive salary
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypePermanent, full-time

Job Description

We are a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products and regenerative medicine.The Role:Reporting to the Head of Manufacturing Operations, you will have direct line management responsibility for multiple teams spread across different manufacturing sites. You will be responsible for leading and motivating RoslinCTs manufacturing teams ensuring safe and smooth execution of the manufacturing master production schedule. As a key member of the RoslinCT management team, the ideal candidate will demonstrate excellent staff management skills combined with the ability to forward plan, assimilate technical knowledge and drive a Quality/improvement/right first time mindset.This position would be an ideal opportunity for someone with prior experience of Biopharmaceutical manufacturing to develop their career in a new and exciting scientific arena. Candidates with previous cGMP cell and gene therapy, mammalian cell culture, sterile manufacturing and/or commercial manufacturing experience would be a good fit for this role.Responsibilities:As a key member of the RoslinCT management team in a fast-paced organisation your responsibilities will be varied, but will include;

  • Working closely with the Manufacturing Section Managers, Lead Biotechnologists and their teams to manage a wide range of manufacturing activities through preparation, scheduling, resource planning, pre-campaign briefing, execution and batch record review to ensure batches are manufactured correctly and released on time, in accordance with the manufacturing master production schedule and customer expectations.
  • Championing of a culture of high performance, focus, low error rate and consistent clean room behaviours with an on the ground approach.
  • Driving improvements to company processes, quality and right first time.
  • Monitoring of resources and training status to ensure they are aligned to the individual, process and commercial demand.
  • Ensure that all team colleagues have development goals which are aligned to corporate objectives.
  • Providing appropriate coaching, mentoring and performance feedback.
  • Providing input to the talent, promotion and salary review processes.
  • Pro-active management of inadequate performance following company guidance and policies.
  • Ensuring compliance with H&S standards (company policies, rules and regulations).
  • Completion, review and approval of quality related documentation including change controls, incidents/deviations and risk assessments in accordance with cGMP and standard operating procedures relating to the role.
  • Leading problem solving and root cause analysis sessions as necessary, providing transparent and open communication both to RoslinCT Senior/Executive Management and clients.
  • Alongside the Project Managers and the wider team, ensure timely, transparent and concise communication on manufacturing activities.
  • Working collaboratively with the RoslinCT Development team and/or client to manage smooth technical transfer of new processes into Manufacturing.
  • Ensure timely creation and/or review of GMP quality documentation including SOPs, batch records, incident/deviation reports, change controls and risk assessments.
    • Values:A key part of working at RoslinCT is being able to embody our company values, which are integral to the work we do here. As such, you should be able to demonstrate:
  • Passion for customer satisfaction
  • Ability to support a one team’ approach
  • Great communication
  • Commitment to personal growth and development
  • Accountability for your work
    • Qualifications:The ideal candidate will hold a Life Science degree, or degree in a related subject, or equivalent relevant training and experience that includes cell culture. Green Belt certification with experience of Lean Six Sigma implementation would be desirable.Skills and Experience:The ideal candidate will demonstrate:
  • Experience leading diverse, multi-functional teams.
  • Experience of cGMP cell and gene therapy, mammalian cell culture, sterile manufacturing and/or commercial manufacturing.
  • Excellent working knowledge of cGMP regulations (UK, European and US) particularly in respect of ATMPs, aseptic processing, contamination control, documentation and record management.
  • Detailed understanding of the expectations associated with ATMP commercial manufacture.
  • Experience of technology process transfer and a working knowledge of PICS and ISO regulations.
    • Benefits:In addition to a competitive salary and the opportunity to join an exciting, rapidly expanding company delivering life-changing therapies, we can offer:
  • Group Personal Pension Plan: 3% Employee contribution with an Employer contribution of initially 5% for the first year of joining the scheme then a 1% increase per year until a maximum of 8% is reached.
  • Group Life Cover, 3X Salary.
  • Health4All Cash Plan: Claim cash back towards dental check-ups and treatment, new glasses, contact lenses and therapy treatments such as physiotherapy and chiropody and more.
  • Employee Assistance Programme.
  • 31 days annual leave with an extra day from 3 years’ service and a further day from 5 years’ service.
  • 4 days public holidays leave.
    • Required skills
  • Cell Culture
  • GMP
  • Six Sigma
  • Staff Management
  • Manufacturing Operations

    • Keyskills :
    GMP Staff Management

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