Sr. QA Specialist Biologicals

  • Location:
    Leiden, NL
  • Education:
    Academic
  • Job type:

    Full Time (36h/w)

Leiden, NL – Bio Science Park

The Position

Are you a Senior QA Specialist ready to play a key role in realizing a state-of-the-art GMP research, development and production facility for cell and gene therapies?  Be among the first to join our expanding team and support the establishment of a sound QMS from scratch and reach GMP certification by early 2022.

At NECSTGEN we work together with our clients to challenge today’s possibilities and get more novel therapies into the clinic and to the patient.

What you will do

NECSTGEN will provide expert knowledge for the development, production and commercialization of cell and gene therapies to a variety of collaborators and customers at various stages of the therapy life cycle. Since NECSTGEN is a scale-up we are looking for a specialist with flexibility and a hands-on mentality.

In short, you as Sr. QA specialist will:

  • Collaborate directly with the Head of QA supporting the QMS realization and accompany the new facility GMP certification process, lead projects;
  • Support the deployment of the new eQMS;
  • Coordinate and collaborate with external consultants;
  • Support the recruitment and training of future QA staff;
  • Support in writing, reviewing and advising on GMP documentation like SOPs, qualification/validation documentation, batch records, etc…;
  • Depending on your ambition and skills, specialize in Quality Systems, operations, projects, or any other interesting direction for the business and you.

About NECSTGEN

At NECSTGEN we look beyond today’s possibilities and together with our clients and partners aim to get more novel cell and gene therapies into the clinic and to the patient. NECSTGEN spun out of the Leiden University Medical Center (LUMC) by recognizing the needs of specifically early-stage research organizations and start-ups to efficiently develop cell and gene therapies.

NECSTGEN is not a regular CDMO but a centre of expertise with a unique position enabling us to dedicate our resources to delivering high quality services accessible for early stage research organizations. We support the translation of novel therapies and technologies to GMP operations and clinical trials.

NECSTGEN offers development and GMP manufacturing services, including fill and finish and brings together expertise from R&D, process development including analytical, Quality Assurance, Quality Control, Regulatory Affairs, Business development and manufacturing in a purpose-built non-profit GMP production facility.

Our current team consists of professionals from industry and academia with an entrepreneurial mind-set and a drive to make a difference. We are a flat organization with a participative management style.

If this position sparks your enthusiasm, we would love to hear from you! Don’t hesitate to contact Geertje Janssen at g.janssen@necstgen.com or +31(0) 6 15 93 34 54 for more information.

What we ask

We are looking for a Sr. QA specialist, preferably with an educational background in Life Science or related and:

  • Over 5 years of experience in GMP;
  • Experience within a sterile manufacturing environment (biologicals, vaccines, injectables, parenterals or ATMPs) this is a must;
  • Experience with writing and reviewing QA documentation and (leading) CAPAs, Change controls and deviations;
  • Understanding of the dynamics, opportunities and demands of a scale-up environment;
  • Hands-on experience with electronic quality systems like Trackwise, EtQ, Doc Space, Doc Share, Agile or related.

Offer

As Sr. QA specialist at NECSTGEN you will enjoy the best of both worlds; excellent fringe benefits, a competitive salary and the opportunities and dynamics of a scale-up environment. A standard fulltime position at NECSTGEN is 36 hours, a parttime position is negotiable. In addition to your salary you receive a 13th-month payment and 8% holiday allowance.

Because as Sr. QA specialist at NECTGEN you will join the team at a very early stage there will be plenty of career opportunities and we support you with a personal training and development plan.

If this position sparks your enthusiasm, we would love to hear from you! Don’t hesitate to contact Geertje Janssen at g.janssen@necstgen.com or +31(0) 6 15 93 34 54 for more information.

Application closes on November 20 or earlier if a suitable candidate is found. First interviews are scheduled for November 2nd.


Head of Production

Netherlands Center for the Clinical Advancement of Stem Cell & Gene Therapies

NECSTGEN LOGO

Netherlands Center for the
Clinical Advancement of
Stem Cell & Gene Therapies

NECSTGEN

Visiting adress
Sylviusweg 62
2333 BE Leiden
Leiden Bio Science Park
The Netherlands

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