Associate Gmp Production Scientist

3 months ago

London, United Kingdom Achilles Therapeutics Full time

Achilles is a fast paced, trail blazing company. We are breaking new ground with our science creating products that have never been made. As no-one has done what we are doing before, there is no playbook to copy. This means we must innovate, adapt and collaborate across our organisation, working together to solve novel problems. This entrepreneurial spirit and approach runs through our company and those who thrive here are able to cope with anything that is thrown at them, enjoy ambiguity and thrive on making things happen even when there is not a detailed brief.
This is role is based at our production facility in the Royal Free Hospital in Hampstead.
Role Purpose
As an Associate GMP Production Scientist you will mainly perform routine manufacturing of clinical products of Achilles advanced therapies, support validation of new equipment and implementation of process changes. You will operate within a highly regulated environment because of the need to control quality and safety of our product. You will have high awareness of the research context of our advanced therapy. If you want to be a part of a well-funded, exciting new start-up, and enjoy playing an active role in supporting the development and clinical manufacture of ATMPs which have the ability to transform the clinical management of cancer, then this is the role for you.

**Responsibilities**:

- Perform the manufacture of Advanced Therapy Medicinal products according to Good Manufacturing Practice within a controlled clean room environment and ensure all manufacturing activities are undertaken in accordance with production requirements and GMP regulatory and quality standards.
- Perform routine maintenance of a laboratory environment suitable for the manufacture of ATMPs, cleaning of laboratories, clean room facilities in accordance with approved standard operating procedures.
- Support routine laboratory equipment maintenance tasks and qualification and validation of new or re-validation of existing equipment.
- Operating highly technical equipment, including but not limited to biological incubators, cell separation and washing devices, centrifuges and cryogenic storage vessels.
- Support process engineering activity in closed system cell culture and identifying and implementing procedures in accordance with GMP and regulatory standards.
- Support continued development and in-process improvement activity to streamline process operations and optimisation of manufacturing methods.
- Assist in receipt and storage of consumables and raw materials.
- Assist with coordination activities with QC to ensure appropriate and timely sampling and testing of in-process samples and finished product.
- Work with external service providers.
- Communicating with a wide range of scientific and non-scientific colleagues within the organisation such as Quality Control, Quality Assurance, Supply chain operators, supervisors as required.
- Be accountable to the head of production for all production operation.

**Requirements**:
Experience Required
- BSC/MSC in a Biological Science discipline.
- 1 years’ experience in a scientific laboratory role.
- Minimum of 1 years’ experience working in a regulated environment (GLP/GCLP/GMP).
- Able to work in a Grade B cleanroom production environment.
- Understanding of GMP, ATMP, and EUTCD regulations
- Strongly focused on quality and safety.
- Have excellent planning and organisational and time management skills.
- Have good communication and interpersonal skills
- Self-motivated with strong initiative and drive.

Desirable
- Experience in human cell isolation, and cell and tissue culture in a GMP compliant environment
- ATMP Process validation experience.
- Working knowledge of generating process and QC data for regulatory submissions.

Profile Required
- Focussed individual with a passion for delivery.
- Team spirited and also able to work independently.
- Solution focussed individual who is adaptable and comfortable with change.
- Results focussed.
- Proactive, someone who looks to make connections and is confident enough to push when they see action is required.
- Quick learner.
- Detail focussed and a completer finisher.
- Good communicator with an ability to influence at every level.
- Excellent planning, organisational and time management skills.
- Attention to detail
- Team Player: Ability to learn from senior and junior members of the team

**Benefits**:
This is a permanent role, offering a competitive benefits package

At Achilles you will enjoy a flexible and dynamic working environment that fosters creativity, leadership, and teamwork. We work hard and deliver a lot
Our benefits package includes a competitive salary and performance related bonus, group pension plan matched up to 6%, life insurance, private medical insurance, and a tax approved all employee share incentive plan.

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