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Amniotics is a stem cell 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 CMO for other companies wishing to produce their ATMP in a GMP licensed facility. All in all, Amniotics envisions to be a team of about 16-20 people from spring 2021.

 

As a growing company, we are always looking for new talent to join our team in Medicon Village in Lund. The working environment is fast-paced, collaborative and outcome-focused. If you are interested in joining our team and inventing tomorrow’s medicines, then send your application to: jobs@amniotics.com

Quality Control Scientist, ATMP and Stem Cells

Amniotics is seeking a Quality Control Scientist who will also be part of the R&D team and participate in development of processes for GMP manufacturing of cells under aseptic conditions. Areas of responsibility will also include running QC testing of finished product.

This position will provide technical expertise in the areas of cell culture, flow cytometry and quantitative PCR. The candidate will help improve processes for drug product manufacturing and participate in the day to day drug product quality control operation to ensure clinical and commercial supply. The position will report to the QC Manager.

Responsibilities

  • Support activities related to the transfer and validation of analytical methods.
  • Perform routine in-process and release QC testing of cell products.
  • Perform routine environmental monitoring.
  • Execute analytical method qualifications, validations and transfers including drafting technical protocols, reports and troubleshooting.
  • Maintain, calibrate and operate equipment and instruments supporting Flow Cytometry.
  • Track and test products according to stability protocols.
  • Complete routine record review of test data and related documents for in-process testing, drug substance and drug product release.
  • Perform QC lab duties and R&D technical projects as required.

Qualifications

  • Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • Experience in a number of analytical techniques, including but not limited to, Flow Cytometry, Real Time PCR, ELISA, Cell Viability measurement, Environmental monitoring etc.
  • Preferred:
    • Experience in performing analytical method validation and supporting method transfer activities.o Experience in QC department in the biotech and/or pharmaceutical industry.
    • Knowledge of GMP, SOP’s and quality control process.
    • Excellent oral and written communication skills. Strong technical writing ability.
    • Experience with cell therapy manufacturing 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: Lisbeth Svensson, QC Manager, +46-73 507 0769, lsv@amniotics.com or Jan Talts, COO, +46-72 327 8530, jt@amniotics.com

You are welcome to send your application with CV to one of the above e-mail addresses. Applications are evaluated on an ongoing basis. The expected starting date is early spring 2021.

Supply Chain Manager / QA, ATMP and Stem Cells

Amniotics is seeking a Supply Chain Manager / QA who will manage Amniotics supply chain and participate in QA activities for GMP manufacturing of cells under aseptic conditions. Areas of responsibility could also include preparing and reviewing CMC related documents for clinical trial applications as well as having contact with suppliers of facility and other services.

The candidate will help improve processes for material and services supply as well as supplier handling to ensure clinical and commercial supply. The position will report to the COO.

Responsibilities

  • Manage all aspects of supply chain including purchasing and shipping
  • Establish and manage strategic sourcing of raw materials and production supplies, including materials of biological origin.
  • Manage all purchasing, warehousing activities, receiving, shipping, storage and inventory control while adhering to cGMP regulations
  • Develop KPI (Key Performance Indicators) to monitor performance
  • Manage vendor oversight, relationships and selection related to supplies and raw materials
  • Work closely with the engineering and production teams to clearly understand technical requirements and sensitivities as they relate to manufacturing
  • Identify and mitigate areas of risk with supplier and vendors
  • Work closely with R&D to source new materials for future and current projects.
  • QA responsibilities as part of the QA team (e.g. QMS maintenance, quality assurance tasks related to deviations, CAPAs, change control

Qualifications

  • Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • Experience in procurement of biological raw and starting materials for biopharmaceutical based GMP manufacturing operations a must.
  • Experience with supplier qualification
  • Experience with Quality Assurance
  • Experience with CMC activities
  • Experience in equipment procurement, maintenance and validation 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: Sidonie Karlsson, Production Manager, +46-73 545 8018, sk@amniotics.com or Jan Talts, COO, +46-72 327 8530, jt@amniotics.com

You are welcome to send your application with CV to one of the above e-mail addresses. Applications are evaluated on an ongoing basis. The expected starting date is early 2021.

Production Scientist, ATMP and Stem Cells

Amniotics is seeking a Production Scientist who will be part of the production team and participate in GMP manufacturing of cells under aseptic conditions. Areas of responsibility will also include process development and validation.

This position will provide technical expertise in the areas of aseptic processing and fill/finish, drug production technology, process analytics and validation of equipment. The candidate will help improve processes for drug product manufacturing and participate in the day to day drug product manufacturing operation to ensure clinical and commercial supply. The position will report to the Production Manager.

Responsibilities

  • 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. Participate in process development and validation. Provide manufacturing feedback on engineering related projects.
  • Participate in equipment and facilities maintenance, as required
  • Identify and implement continuous improvement opportunities.

Qualifications

  • Minimum BS degree in biological sciences, biochemistry, chemical engineering, bioengineering, or related technical field, or equivalent industry experience.
  • Experience in biopharmaceutical based GMP manufacturing operations.
  • Experience in cleanroom operation and aseptic processing
  • 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: Sidonie Karlsson, Production Manager, +46-73 545 8018, sk@amniotics.com or Jan Talts, COO, +46-72 327 8530, jt@amniotics.com

You are welcome to send your application with CV to one of the above e-mail addresses. Applications are evaluated on an ongoing basis. The expected starting date is early 2021.

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