Lead Manufacturing Biotechnologist - Clinical Projects

RoslinCT; City of Edinburgh; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading biotechnology company in Edinburgh is seeking a Lead Manufacturing Biotechnologist to oversee clinical projects in cell and gene therapy. This role includes direct management of a team, compliance with regulatory standards, and hands-on manufacturing activities. The ideal candidate will have a degree in Life Sciences and experience in cGMP environments, with strong communication and organisational skills. The company offers a competitive salary and comprehensive benefits package.

Benefits

31 days of annual leave plus public holidays

Competitive salary package

Pension scheme

Group Life Cover

Private healthcare

Flexible benefits including retail discounts

Qualifications

• Direct line managerial or supervisory experience is required.
• Experience in a cGMP manufacturing operation.
• Competence in documentation and record management.

Responsibilities

• Lead hands-on activities in manufacturing cell and gene therapy products.
• Manage quality-related documentation per SOPs.
• Assist in validating new production processes and equipment.
• Provide technical leadership for manufacturing projects.
• Serve as point of contact for client updates and information.
• Line manage a team of Manufacturing Biotechnologists.

Skills

Direct line managerial or supervisory experience

Experience with cGMP manufacturing

Cell culture methods and techniques

Knowledge of cGMP, PICS, and ISO regulations

Exceptional verbal and written communication skills

Continuous improvement mindset

Excellent organisational skills

Education

Degree in Life Sciences

Job description

Overview

Lead Manufacturing Biotechnologist – Clinical Projects

Location: Edinburgh BioQuarter

RoslinCT is a world-leading cell and gene therapy contract development and manufacturing organisation creating cutting-edge therapies that change people’s lives. Collaborative, dedicated and talented people are the backbone of our culture, working both autonomously and in driven teams to make life-changing products utilising ground-breaking science. Find out more about what we do here.

Why join us?

• The opportunity to join a rapidly expanding company which is changing lives, giving you the skills and experience to develop your career.
• A generous salary package – we reward our people at the level they deserve.
• 31 days of annual leave, plus 4 public holidays which increases with tenure.
• A competitive company pension scheme to help you save for the future.
• Group Life Cover – you are automatically covered for three times your basic salary to give you and your family peace of mind.
• Private healthcare and access to mental health/wellbeing support as your health and wellbeing means a lot to us.
• Flexible benefits such as retail discounts and access to the Cycle2Work scheme.

Your new role

The Lead Manufacturing Biotechnologist – Clinical Projects role is situated within the Manufacturing team who are responsible for the delivery of various Cell and Gene Therapy cell banks and drug products predominantly in the clinical phases of drug product development. This position involves performing direct hands-on activities associated with the manufacture of these products, ensuring all required quality and regulatory standards are met. You’ll also work within a cleanroom environment and provide line management support to a team of Manufacturing Biotechnologists.

• Supporting ongoing projects in the Manufacturing team, including processing technical transfer and GMP translation from laboratory to cleanroom.
• Completion of quality related documentation including batch production records, change controls, incidents / deviations and risk assessments in accordance with SOPs.
• Planning and supporting the validation of new production processes and equipment. Routine qualification, calibration and maintenance of production equipment.
• Providing technical leadership of manufacturing projects / campaigns.
• Point of contact for the client providing written and verbal technical / batch progress updates and other information when required.
• Line managing a team of Manufacturing Biotechnologists including managing employee performance and development.

About you

• Direct line managerial or supervisory experience.
• Experience working within a cGMP manufacturing operation, dealing with requirements in respect of aseptic processing, contamination control, documentation and record management.
• Experience of cell culture methods and techniques.
• Working knowledge of cGMP, PICS and ISO regulations.
• Exceptional verbal and written communication skills, with the ability to explain technical concepts clearly.
• Driving continuous improvement, encouraging right first-time execution.
• Taking responsibility for continually setting high standards, by developing and improving our processes.
• Excellent organisational skills, with the ability to plan ahead, deliver results and manage several tasks.

Qualifications

• A Degree within a Life Sciences discipline.

Next Steps

If this sounds like you, then please hit ‘Apply’ now. We will ask you to upload your CV and complete a short application form detailing why you are interested and why we should hire you.

At RoslinCT, we’re all about inclusivity and creating a fair, welcoming workplace. Our goal is to make sure everyone knows they’re valued and encouraged to be themselves, whether they’re our employees, customers, or partners.

We take pride in being an equal opportunity employer. We treat all applicants fairly and don’t discriminate based on any protected characteristics. So, no matter who you are, we welcome your application with open arms.

If you’ve got any specific needs or concerns regarding accessibility during the recruitment process, don’t hesitate to reach out to us at [e-mail]. We’re here to assist and make things as smooth as possible for you.