Lead Manufacturing Biotechnologist

7 months ago

Edinburgh, United Kingdom RoslinCT Full time

**Lead Manufacturing Biotechnologist - Commercial Manufacturing**

**Location**: Edinburgh BioQuarter, Little France

**Who are we?**

We are RoslinCT, 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 will provide leadership to a team of scientific and technical employees responsible for the manufacture of an autologous, commercially licensed, Nobel prize winning CRISPR-Cas9, gene-edited product according to Good Manufacturing Practice within a highly controlled clean room environment.
- Provide line management and leadership to a team of Manufacturing Biotechnologists and Manufacturing Technicians. Please note this is a shift-based position.
- Accountable for their team’s general compliance, completion of quality related documentation (manufacturing batch records, forms, and logbooks) to a high level of GDP following all relevant standard operation procedures and instructions.
- Foster a professional, inclusive, and supportive team environment.
- Contribute to the wider manufacturing management team by working collaboratively with senior colleagues to ensure a consistent approach to management and problem solving.
- Ensure controlled documents as part of the quality system are prepared, issues, managed, and updated in compliance with Good Manufacturing Practice.
- Perform document management duties using Q-Pulse electronic document management and paper-based systems, including but not limited to manuals, policies, SOPs, forms, and logs.
- Responsible for day-to-day co-ordination and decision-making in respect of their team, escalating more complex matters to the Manufacturing Section Manager and/or Manufacturing Manager as required.
- Plan and undertake the validation of new production processes and equipment. Routine qualification, calibration, and maintenance of production equipment.
- Provide technical leadership of manufacturing products/campaigns.
- Act as the manufacturing point of contact for the client providing written and oral technical/batch progress updates and other information as required. Liaise with the manufacturing training team to ensure development of relevant training pathways for all direct reports and support the timely achievement and delivery of all milestones.

**About you**
- Relevant experience within a cGMP manufacturing documentation.
- Experience of cell culture methods and techniques.
- Experience of working in an aseptic sterile manufacturing environment or supporting functions.
- Excellent working knowledge of cGMP requirements in respect of aseptic procession, contamination control, documentation, and record management.
- A working knowledge of cGMP and the regulatory requirements associated with ATMP and sterile pharmaceutical manufacturing.
- You will have excellent communication and interpersonal skills and a proven track record in building effective relationships with stakeholders across the organisation.
- Ability to handle multiple priorities in a very dynamic environment.
- You must have a good working knowledge of Microsoft Office and other planning tools as appropriate.
- Excellent attention to detail and administration and record keeping skills.
- Ability to learn and share knowledge with the management team and the wider team where appropriate.

**Qualifications**
- A degree in a Life Science discipline.

**Next Steps**
- 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._

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