RoslinCT is looking for a driven individual to join us a Manufacturing Manager. We are a world-leading contract manufacturing and development organisation, specialising in the field of cellular therapies, advanced therapeutic medicinal products and regenerative medicine.
We have embarked on an exciting period of growth and are now recruiting across all our teams to support our expansion. This position of Manufacturing Manager forms a key part of that growth.
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 RoslinCT's 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.
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.
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
Commitment to personal growth and development
Accountability for your work
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.
The ideal candidate should also be able to demonstrate:
Exceptional organisational and planning skills with the ability to plan ahead whilst delivering to deadline. Ability to handle multiple priorities in a client facing, dynamic environment.
Accountability for performance and drive for right first time execution of manufacturing processes.
Excellent communication and interpersonal skills and a proven track record in maintaining effective relationships and working with a wide range of people.
Excellent oral and written communication skills; able to explain technical or complex concepts in a clear format.
Proven logic and decision making abilities, critical thinking skills.
Excellent administration and record keeping skills.
Ability to learn and share knowledge with the management team and the wider team where appropriate.
Excellent attention to detail.
A determination to succeed, with a ‘can do attitude’.
A determination to continually develop and improve standards.
Ability to create a positive environment through self-awareness and social skills.
Ability to take responsibility for setting high standards and looks at the bigger picture to recognise the impact of actions.
Emotional resilience and an ability to work under pressure with good humour.
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.
We are based at Edinburgh BioQuarter, which acts as a hub for Scottish Life Science with close links to the University and the Royal Infirmary.
Please apply via the following link - https://roslinct.peoplehr.net/Pages/JobBoard/Opening.aspx?v=91286727-e30...