Bio-Process Engineer, Cell Therapies and ATMP

Are you ready to join a team committed to move cell therapies into clinical and commercial settings by supplying high quality neonatal amniotic MSCs for cell therapy use? Amniotics is at the start of an exciting journey, and we are looking for passionate individuals to join us on this important mission.

Amniotics is a pharmaceutical company, dedicated to developing and commercializing novel treatments for the benefit of patients suffering from rare and life-threatening diseases, and to function as a CDMO for other organizations wishing to produce their ATMP in a GMP licensed facility. All in all, Amniotics is currently a team of 7 and envision to be a team of about 10 people from autumn 2024.

Amniotics is seeking a Bio-Process Engineer who will be part of the production team and participate in GMP manufacturing of cells under aseptic conditions. Areas of responsibility will include installing, validating, and maintaining equipment and facilities as well as process development.

In this position, you will participate in the day-to-day drug product manufacturing operation to ensure clinical and commercial supply, using your technical expertise in the areas of aseptic processing, cell culture and aseptic fill/finish. You will also help improve processes for drug product manufacturing. The position will report to the Production Manager.

Amniotics uses English as the company language.

Responsibilities

· Maintain equipment and facilities, contact with suppliers.

· Produce clinical and commercial material that meets the company’s strategic objects and is compliant with GMP and safety regulations.

· Participate in investigations as related to the manufacturing process.

· Participate in tech transfer of new products and processes into the manufacturing area. Provide manufacturing feedback on engineering related projects.

· Identify and implement continuous improvement opportunities.

Qualifications

· Experience in biopharmaceutical based GMP manufacturing operations.

· Experience in cleanroom operation and aseptic processing

· Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.

· Experience in cell culture, aseptic fill/finish and pharmaceutical development a plus.

Please note this job description is not an exhaustive listing of activities, duties or responsibilities for this job. Duties, responsibilities and activities may change over time. This is a permanent position with a 6-month trial period.

For further information regarding the position, please contact:

Jan Talts, Production Manager, COO, +46-72 327 8530, jt@amniotics.com

You are welcome to send your application with CV to the above e-mail address. Applications are evaluated on an ongoing basis. The expected starting date is ASAP.