Team Leader - Cellular Therapy Manufacturing (full time)

The Position

You will work under the direction of the Manager Production and lead a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. The Team Leader – Cellular Therapy Manufacturing works with autologous and allogeneic cell products in accordance to GMP conditions in a clean-room environment. In this position, the team leader will interact with PharmaCell clients and he/ she can make an important contribution to advancing this exciting new area of drug development for a number of international companies.

You have affinity with GMP guidelines and you like to work in a quality-oriented environment. Experience with standard cell culturing techniques and analytical procedures (cell counting, viability, sterility sampling etc.) is a must.  You are a people-oriented team leader and -player, pro-active thinker, accurate, precise and constructively critical.A willingness to work flexible hours (incl. weekends) when required, and shifts is important.

 Responsibilities:

·          Responsible for production planning (including logistical organization of resources, material and equipment)

·          Leading a small team of biotech associates

·          Assist with writing on NCs, PDs and CAPAs

·          Accurate documentation and control according to GMP (reviewing batch records etc.)

·          Collaboration within installation and qualification of equipment

·          Application of cell biology and (human) cell culturing techniques (cell counting etc.).

·          Execution of pharmaceutical cell culture processes and other related procedures

·          Performing facility and equipment duties (Environmental monitoring of facility, equipment/ room clearance/ cleaning, trouble shooting)

·          Assist with writing protocols, reports, SOP and Batch production documents  (internally or for international companies)

·          Cross-departmental cooperation regarding technology transfer into production scale

Qualifications:

·          MSc.  in Molecular Biology, Biotechnology, Medical Biology or equivalent with focus on cell biology and/ or human cell culturing techniques (stem cells, primary cells and/or tissue culture)

·          5 years tissue or cell culture experience in a lab or GMP environment (preferably in an industrial environment).

·          Good proficiency in English

·          Good knowledge of standard MS-Office products

Manager Quality Enginering and Logistics (full time)

The Position

You will be responsible for the coordination, supervision and execution of the main engineering activities of the equipment and infrastructure within PharmaCell’s GMP quality systems (operate EMS/ BMS). The activities will include installation, maintenance, calibration and qualification of lab and GMP-production equipment. You will work closely with the department managers and team members to ensure timely maintenance and (re-) qualification of equipment to ensure uninterrupted operation of the facility at all times with minimal downtime. Furthermore, you will have responsibility for warehousing and international.

You have affinity with GMP guidelines and you like to work in a quality-oriented environment. A willingness to work flexible hours and perform on call duties when required is important.

Responsibilities:

·          Arrange planning for preventive maintenance, calibration and re/-qualification activities internaly and with suppliers (first contact person for suppliers)

·          Perform small engineering and maintenance activities by daily/ weekly/ yearly checking/ monitoring of the equipment status (e.g. testing power back-up system, first contact person for breakdown maintenance)

·          Accurate documentation and control of maintenance, calibration and qualification activities on equipment according to GMP (logbooks, equipment management system (EMS), equipment dossier etc.)

·          Operate the Building Management System (BMS) and associated installations; follow-up on alarms as main contact person (incl. schedule for TD). Main contact person for all operation activities related to BMS/ datalogger. Support in budget planning for engineering and maintenance activities

·          Writing, reviewing and approval of qualification documents, user requirement specification (URS), qualification/ re-qualification report, Standard Operation Documents, training documents

·          Assist in improvement of new processes and contribute in solutions for process bottlenecks with respect to equipment related activities

·          Responsibility for warehousing (incoming and outgoing goods, inventory management) and international logistics (delivery of cell samples/vials to and from hospitals and client facilities).

Qualifications:

·          BSc. (HLO) in biotechnological/pharmaceutical engineering, or technical (MLO) degree with 5 years of experience.

·          Experience with equipment qualification tasks (IQ, OQ, PQ), writing URS

·          Experience with HVAC, water systems, alarm systems,data logging systems and basic biotechnology equipment (centrifuges, incubators, LAFC, pumps, balances etc.) is recommended

·          Experience in working with GMP quality systems

·          Prior experience with warehousing and logistics a plus

·          Good proficiency in English

·          Good knowledge in standard MS-Office products

·          Good knowledge in process engineering,

·          Good knowledge of equipment management systems and building management systems

Biotech Associate - Cellular Therapy Manufacturing (full-time)

The Position

You will work under the direction of the supervisor in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. The Biotech Associate – Cellular Therapy Manufacturing works with autologous and allogeneic cell products in accordance to GMP conditions in a clean-room environment. In this position individuals can make an important contribution to advancing this exciting new area of drug development for a number of international clients.

You have affinity with GMP guidelines and you like to work in a quality-oriented environment. Experience with standard cell culturing techniques and analytical procedures (cell counting, viability, sterility sampling etc.) is a must.  You are a proactive thinking team-player, accurate, precise and constructively critical.  A willingness to work flexible hours (incl. weekends) when required, and shifts is important.

  Responsibilities: