Manufacturing Engineer (stem-cell products), Procella Therapeutics AB

At Procella Therapeutics (part of Smartcella Holding AB) we provide advanced capabilities within stem cell therapy development and have inhouse cGMP manufacturing. We have globally licensed cardiac stem cell therapy in clinical stages (in strong collaboration with AstraZeneca) and a growing pipeline of life changing stem cell therapies.

We are now seeking motivated Manufacturing Engineers, for permanent positions, to join the growing on-site manufacturing team in Tullinge, Stockholm.

Overview

You will be responsible for securing GMP compliance and technical readiness of the facility, equipment, process, and product. You will also be required to work within grade D, C, and B cleanroom classified areas applying a high standard of good manufacturing practices (GMP) and good documentation practices (GDP) as outlined by annex 1.

Your focus will be to support the GMP (clinical and/or commercial) manufacturing of ATMP, cell products and you will be required to display a continuous improvement mind set. The role includes cross-functional collaboration with other departments such as MSAT, QA, and Supply Chain.

The department will ensure compliance with Procella quality management systems, registered files, current regulatory requirements and quality criteria.

Responsibilities

- Produce clinical and/or commercial stem cells therapies in accordance with regulatory requirements.

- Support the daily activities in the GMP, cleanroom facility.

- Support cross-functional and external activities related to manufacturing.

- Execute GMP processes according to production schedules and instructions (e.g. MBR , eMBR, SOP, PTP, sampling plans, and work instructions).

- Take part in media fills / Aseptic process simulations.

- Comply with company policies, risk assessments, instructions, and protocols.

- Prepare, review, and revise GMP critical documentation.

- Participate in projects (e.g., internal, and external tech transfer activities, validations, eMBR construction, etc).

- Support periodic calibration, and maintenance and act as a superuser for equipment, instruments, and systems.

- Handling CAPA and initiation of deviation and investigations.

- Supervise and train team members in cleanroom environments and processes.

- Document and monitor quality issues through Procella quality systems.

- Initiate, review and approve change cases.

- Identifying and implementing areas of improvement.

- Ensure GMP compliance by complying with Procellas quality system and relevant guidelines, standards, and regulatory requirements

- Ensure GMP compliance within the development of documentation, revision, and training.

- Ensure GMP compliance within the validation lifecycle of equipment, systems, utilities, and processes.

Required qualifications

Practical experience:

- At least 2 years of proven experience working in a GMP manufacturing and/or quality control environment, including hands-on laboratory-based cell culturing experiences (preferably experiences growing stem-cells in various conditions).

Education:

- University degree (eg. BSc, MSc) in life science (biochemistry, chemistry, molecular biology, microbiology or in other relevant area).

This is a unique opportunity and you will be part of a great organization within the SmartCella group. Initial focus is to act hands-on to produce life changing products according to critical quality standards and to project plan. As the business grows there will be great opportunities for personal development and to take on new exciting projects/roles. You will receive a competitive compensation package including pension-, health covering- and insurance plans including a competitive monthly salary.

Submit your application today! We will review applications on an ongoing basis and hope to fill the position as soon as possible.

Reach out to Markus at markus.dahl@valleyrecruitment.se for questions regarding both the position and company.

About the company

SmartCella is a world-leading biotech & medtech company pioneering the future of targeted therapies by combining first-in-class delivery platforms with cutting-edge cell and gene therapies. The SmartCella group consist of SmartCella Holding AB, ProCella Therapeutics AB, SmartWise AB and SmartCella Solutions AB with a total of 60 employees from more than 20 nationalities.

Homepage: https://www.smartcella.com/procella/