Team Leader - Cellular Therapy Manufacturing - (full-time)

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

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. This position will entail evening- and night work in an alternating shift program.

Responsibilities:

Team Leader Quality Control - (full-time)

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

Team Leader Quality Control (full-time)

The Position

You will work under the direction of the Manager Quality Control and lead a small team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. The Team Leader Quality Control works with autologous and allogeneic cell products in accordance to GMP conditions. Together with colleagues in Manufacturing and Quality Assurance the Team Leader Quality Control will be instrumental in the successful release of patient-specific medicines. 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 biological assays and analytical procedures (ELISA, FACS, cell counting, viability, sterility testing etc.) is a must. You are a people-oriented Team Leader, pro-active thinker, accurate, precise and constructively critical. This position will entail evening- and night work in an alternating shift program.

Responsibilities:

• Responsible for all QC assays (safety, potency and identity tests) and documentation compliant to GMP. Tests involve cell biological and microbiological techniques.
• Review and approval of QC related batch / unit documentation
  Writing and proactive follow-up of Non-Conformances, Planned Deviations and Corrective And Preventive Actions
• Writing SOPS and GMP documentation
• Trending assays and analytical methods
• Management and independent trouble-shooting for QC activities as shift supervisor
• Cross-departmental cooperation regarding technology and method transfer from clients into the QC department and preparing all work for routine testing to ensure efficient processing and timely release of final product
  

Qualifications:

• BSc./MSc. degree 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 experience in an industrial QC laboratory working on cell biological and cell culturing techniques (ELISA and flow cytometry and/or microbiological training is essential)
• Experience with GMP is required
• Motivation to take responsibility for patient outcomes and strict adherence to time schedules
• Strong communication skills with team and other departments (Manufacturing, QA, sponsor)
• Good proficiency in English
• Good knowledge of standard MS-Office products

Contact:
PharmaCell B.V.                   
Marianne Hellwig 

Mailing address:
Oxfordlaan 70
6229 EV  MAASTRICHT
The Netherlands
m.hellwig@pharmacell.nl
Telephone:  +31 43 3509910

Biotech Associate - Cellular Therapy Manufacturing (full-time)

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

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 when requiredis important. This position will entail evening- and night work in an alternating shift program.

 Responsibilities:

·    Execution of pharmaceutical cell culture processes (large and small) and other
     related procedures (sample preparation, sample shipping, media preparation,
     tool box preparation, ordering procedure, assist with logistics activities)
·    Accurate documentation according to GMP (e.g. filling out batch records, 
     writing reports)
·    Assistance in performing facility and equipment duties (assistance with 
     environmental monitoring of facility, equipment, room clearance/cleaning, 
     trouble shooting)

 Qualifications:

·    BSc. (Dutch qualification: HBO) with focus on biotechnology, bioprocessing, 
     cell biology and/ or human cell culturing techniques (stem cells, primary cells 
     and/or tissue culture)
·    2-5 years tissue or cell culture experience in a lab or GMP environment 
     (preferably in an industrial environment). Alternatively, technician-level (MLO) 
     degree with 5 years industrial experience in a biotech production environment
·    Good proficiency in English
·    Good knowledge of standard MS-Office products

Contact:
PharmaCell B.V.
Marianne Hellwig

Mailing address:
Oxfordlaan 70
6229 EV  MAASTRICHT
The Netherlands
m.hellwig@pharmacell.nl
Telephone +31-43-350 9910

Quality Control Associate (full-time)

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

Quality Control Associate (full-time)

The Position

You will work under the direction of the Team Leader QC in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. The Quality Control Associate works with autologous and allogeneic cell products in accordance to GMP conditions. Together with colleagues in Manufacturing and Quality Assurance the Quality Control Associate will be instrumental in the successful release of patient-specific medicines. 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 biological assays and analytical procedures (ELISA, FACS, cell counting, viability, sterility testing etc.) is a must.  You are a people-oriented team player, pro-active thinker, accurate, precise and constructively critical. This position will entail evening- and night work in an alternating shift program.

Responsibilities:

·         Responsible for taking and handling of test samples
          Responsible for all QC assays (safety, potency and identity tests), and
          documentation compliant to GMP. Tests involve cell biological and
          microbiological techniques
·         Release of incoming materials
·         Ensure proper operations of laboratory equipment
·         Initiation of Non-Conformances, Planned Deviations and Corrective And
          Preventive Actions
·         Cross-departmental cooperation to ensure timely processing and reporting
          of results

Qualifications:

·         MLO/HLO degree 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)
·         2-5 years experience in an industrial QC laboratory working on cell biological
          and cell culturing techniques (ELISA and flow cytometry training is essential)
·         Experience with GMP is highly preferred
·         Motivation to take responsibility for patient outcomes and adherence to time
          schedules
·         Good proficiency in English
·         Good knowledge of standard MS-Office products

Contacts:
PharmaCell B.V.
Marianne Hellwig

Mailing address:
Oxfordlaan 70
6229 EV  MAASTRICHT
The Netherlands
m.hellwig@pharmacell.nl
Telephone: +31-43-3509910

Quality Assurance Officer (full-time)

PharmaCell is an energetic, young company acting as a Contract Manufacturing Organization (CMO) in the area of cell therapy and regenerative medicine (tissue culturing). The company works with European and US-based biotechnology companies on clinical development projects and offers GMP and regulatory consultancy, cell culturing process development, fill and finish, QC-testing and GMP production services, as well as storage and distribution of clinical trial materials. The company is based in Maastricht (Netherlands), conveniently located at approximately 1 hour driving distance from Brussels, Antwerp, Cologne and Dusseldorf.

Quality Assurance Officer (full-time)

The Position
You will work under the direction of the Director QA in a team of young, driven professionals in a GMP environment on projects related to cell therapy and regenerative medicine. The Quality Assurance Officer works with autologous and allogeneic cell products in accordance to GMP conditions. Together with colleagues in Manufacturing and Quality Control the Quality Assurance Officer will be instrumental in the successful release of patient-specific medicines. 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. An understanding of aseptic processing and analytical procedures (cell counting, viability, sterility testing etc.) is a preferred.  You are a proactive thinking team-player, accurate, precise and constructively critical. This position will entail evening- and night work in an alternating shift program.

Responsibilities

• Responsible for schedule adherence for QA specific tasks: performs batch record review, resolve deviations and close out investigations, as outlined in the principal accountabilities
• Responsible for administration, and reporting of  progress (QPI) on the Quality Key Performance Indicators such as Non-Conformances,  Change control, CAPAs
• Responsible for reviewing and approving process related master documentation and writing and implanting procedures for Quality systems
• Responsible for introduction of GMP related training program for PharmaCell.
• Participate in external and internal audit program
• Secretary of the Quality Review Board
  

Qualifications

·         HLO/BS degree in Life Sciences- biochemistry, biology or biotechnology
·         Minimal 5 years relevant experiences in GMP – regulated industry is required
          of which minimal 2 years at Quality Assurance and at least 3 years in     
          Production (e.g. Aseptic Processing) or Quality Control (cell based assays or
          pharmaceutical microbiology)
·         Good Knowledge of cGMP regulations, preferably in Advanced Therapeutic
          medicinal Products (ATmPs), and the current Industry Standards
·         Demonstrated proficiency in word processing and database/spread sheet
          applications
·         Familiar with Operational Excellence
·         Strong organizational skills and can work independently
·         Strong communication skills (oral and written)
·         Commitment to Quality and promotion of Quality Standards
·         Drive for Decision Making and Resolution of Quality Issues
·         Commitment to solve Patient needs

Contacts:
PharmaCell B.V.
Marianne Hellwig

Mailing address:
Oxfordlaan 70
6229 EV  MAASTRICHT
The Netherlands
m.hellwig@pharmacell.nl
Telephone: +31-43-3509910